Acute Kidney InjuryPhase 3PHOS-CRRTNCT07550894

Phosphate-Containing Replacement Fluid for Patients Undergoing CRRT

A Phase 3 study testing Phosphate-containing Replacement Fluid and Standard Phosphate-free Replacement Fluid in people with Acute Kidney Injury and Sepsis, run by Sun Yat-sen University at 15 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Brief Summary: Evaluating a New Phosphate-Containing Fluid for Blood Purification (CRRT) Why is this study being done? Patients in the Intensive Care Unit (ICU) often need a treatment called Continuous Renal Replacement Therapy (CRRT). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Kidney Injury, Sepsis, Critically Ill Patients Requiring Continuous Renal Replacement Therapy
What is being tested?: Phosphate-containing Replacement Fluid and Standard Phosphate-free Replacement Fluid
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 220 participants
Where: 15 sitesChina
Study dates: 1 May 2026to 30 Jun 2028
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants must meet all of the following criteria to be eligible for the study:
Aged 18 years or older, regardless of gender.
Meet the clinical indications for Continuous Renal Replacement Therapy (CRRT) as defined by the "Standard Operating Procedures for Blood Purification (2021 Edition)" and assessed by a qualified nephrologist or intensive care physician.
Expected continuous blood purification duration is 72 hours or longer.
The participant or their legal guardian has a full understanding of the purpose and significance of the trial, voluntarily agrees to participate and comply with the study procedures, and has signed the written Informed Consent Form (ICF).

Who cannot join

Participants meeting any of the following criteria will be excluded from the study:
Known allergy to any component of the investigational drug, or individuals with an allergic constitution.
Inability to establish suitable vascular access for CRRT.
Persistent hypotension (Systolic Blood Pressure < 90 mmHg or Mean Arterial Pressure < 65 mmHg) that is difficult to correct, unless judged by the investigator as potentially correctable with intervention.
Presence of malignant tumors with systemic metastasis (except for those who previously underwent radical surgery without recurrence).
Pregnant or breastfeeding women.

Show all 10Show fewer

Receipt of any form of renal replacement therapy (RRT) or blood purification treatment within 24 hours prior to screening.
Receipt of peritoneal dialysis within 24 hours prior to screening.
Participation in any other clinical trial involving investigational drugs or devices within 1 month prior to screening.
Any other condition or reason that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jianfeng Wu, MD PhD contact

+86-20-87755766 ext 8454

wujianf@mail.sysu.edu.cn

Chuanxi Chen, MD PhD contact

+86-20-87755766 ext 8454

chenchx23@mail.sysu.edu.cn

City, postcode or hospital

15 sites in 1 country

China15 sites

Sichuan Provincial People's Hospital
Chengdu, Sichuan
Xiaobo Huang, 8628-87393999, drhuangxb@163.com
West China Hospital of Sichuan University
Chengdu, Sichuan
Ping Fu, 8628-85422114, fupinghx@scu.edu.cn
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Fachun Zhou, 8623-88955818, zhoufachun@hospital.cqmu.edu.cn
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
Zhongqing Chen, 86-13503049103, 13503049103@163.com
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong
Xiangdong Guan, 8620-87755766, guanxd@mail.sysu.edu.cn
Wei Chen, MD, PhD
The Third Affiliated Hospital, Sun Yat-Sen Unive
Guangzhou, Guangdong
Benquan Wu, 8620-85253333, zswbq@163.com
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong
Zhanguo Liu, 8620-62782020, zhguoliu@163.com
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan
Junxia Wang, 86-18638859997, lyyzwjx@126.com
Jiangsu Province Hospital
Nanjing, Jiangsu
Huijuan Mao, 8625-52271000, maohuijuan72@njmu.edu.cn
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
Shulin Xiang, 86771-2803237, xiangshulin27@163.com
Renji Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality
Yuan Gao, 8621-58752345, gaoyuanzhuren@126.com
Shanxi Provincial People's Hospital
Taiyuan, Shanxi
Xiaoshuang Zhou, 86351-4960081, zhouxiaoshuang@sxmu.edu.cn
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei
You Shang, 86-15972127819, you_shanghust@163.com
The First Affiliated Hospital of Xi 'An Jiaotong University
Xi'an, Shaanxi
Qindong Shi, 8629-85323200, shiqindong@163.com
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Zhanzheng Zhao, 86-13938525666, 13938525666@139.com

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Parallel-Controlled, Multicenter, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Phosphate-Containing Replacement Fluid in Continuous Renal Replacement Therapy

A common problem during this treatment is that vital minerals, like phosphate, are washed out of the blood along with the toxins. Low phosphate can lead to muscle weakness and breathing problems. Currently, doctors must manually add phosphate to the treatment fluids, which can be inconsistent. This study aims to test a new, pre-mixed fluid that already contains phosphate to see if it works better and is safe.

What are the main questions the study aims to answer?

Does the new fluid help keep phosphate at a healthy level in the blood during the first 72 hours of treatment?

How does the new fluid affect kidney function compared to the standard fluid?

Is the new fluid safe for patients to use?

Who can take part in this study?

The study is looking for adults (18 and older) who:

Are in the ICU and need CRRT treatment as decided by their doctor.

Are expected to need this treatment for at least 72 hours.

Are willing to participate (or have a legal guardian who agrees).

People who are pregnant, have known allergies to the fluid ingredients, or have very low blood pressure that cannot be corrected may not be able to join.

How will the research happen? This is a "double-blind" study involving 220 participants across 15 hospitals. This means neither the patients nor the doctors will know which fluid is being used until the study is over.

Participants will be put into one of two groups by a computer:

Group 1 (New Fluid): Receives the blood purification fluid that has phosphate already in it.

Group 2 (Standard Fluid): Receives the standard fluid that does not have phosphate.

What will participants have to do?

Receive Treatment: Participants will receive their assigned fluid during their normal CRRT care for up to 7 days.

Blood Tests: Doctors will take regular blood samples to check mineral levels and kidney health.

Monitoring: The medical team will closely watch participants for any side effects or safety concerns.

Follow-up: There will be a safety check-up 7 days after the treatment ends.

Possible Benefits and Risks The new fluid may help prevent low phosphate levels, which could help with recovery. However, as with any medical treatment, there is a risk of side effects or electrolyte imbalances. The research team will monitor every participant 24/7 to ensure their safety.

Read the detailed description

Scientific Rationale and Study Objective:

Continuous renal replacement therapy (CRRT) is a standard life-support intervention in the ICU. However, standard phosphate-free replacement fluids frequently lead to unintended phosphorus removal, causing treatment-induced hypophosphatemia. This electrolyte imbalance is clinically significant, as it is linked to impaired muscle function and delayed respiratory weaning. This Phase III trial evaluates a novel, pre-mixed, phosphate-containing replacement fluid designed to maintain physiological phosphorus homeostasis and provide high-quality evidence for its standardized use in preventing CRRT-induced complications.

Study Design and Multicenter Implementation:

This is a randomized, double-blind, parallel-controlled trial conducted across 15 tertiary medical centers in China. A total of 220 participants requiring ≥ 72 hours of CRRT will be randomized 1:1 via a central Interactive Web Response System (IWRS). The study utilizes a dual-primary endpoint framework to demonstrate that the phosphate-containing fluid is non-inferior to standard therapy in renal replacement efficacy (creatinine clearance) and superior in preventing hypophosphatemia (serum phosphorus < 0.81 mmol/L). All sites follow a standardized CRRT protocol, including unified blood flow rates and effluent dosing, to minimize confounding variables.

Blinding and Intervention Protocol:

To ensure the integrity of the double-blind design, the experimental phosphate-containing fluid and the control fluid are identical in appearance, labeling, and packaging. The intervention lasts for a maximum of 7 days, followed by a 7-day post-treatment follow-up. Clinical monitoring includes regular assessments of vital signs, fluid balance, and blood gas analysis. Secondary outcomes focus on organ function (SOFA scores), mechanical ventilation duration, and comprehensive metabolic stability, including glycemic and electrolyte balance.

Data Management and Quality Assurance:

Data integrity is managed through an Electronic Data Capture (EDC) system with rigorous Source Data Verification (SDV) at all 15 sites to ensure compliance with Good Clinical Practice (GCP). An independent Data Monitoring Committee (DMC) is established to periodically review safety data and protect participant welfare, ensuring the scientific rigor and safety of this multicenter clinical investigation.

Conditions: Acute Kidney Injury, Sepsis, Critically Ill Patients Requiring Continuous Renal Replacement Therapy
Being tested: Phosphate-containing Replacement Fluid, Standard Phosphate-free Replacement Fluid
Keywords: CRRT, Phosphate-containing replacement fluid
Medical subject headings: Acute Kidney Injury, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Phosphate-containing Replacement FluidDrug
Phosphate-containing Replacement Fluid is an investigational Class 2.3 modified chemical drug approved by the NMPA (No. 2021LP00824). It is a premixed, electrolyte-balanced replacement fluid containing phosphorus. The solution is administered via the extracorporeal circuit during Continuous Renal Replacement Therapy (CRRT). The dosage and flow rate are standardized according to the subject's body weight and clinical requirements (typically 25-35 mL/kg/h).
Standard Phosphate-free Replacement FluidDrug
A marketed phosphate-free replacement fluid (standard of care). Administration via extracorporeal circuit with doses identical to the experimental group. Treatment is expected for 72 hours, up to a maximum of 7 days, or until CRRT is clinically terminated. This comparator evaluates the efficacy of the phosphate-containing solution in preventing treatment-induced hypophosphatemia.

Study groups in NCT07550894
Study group	Role	What they receive
Experimental Group: Phosphate-containing Replacement Fluid	Experimental	Participants in this arm will receive the phosphate-containing replacement fluid during Continuous Renal Replacement Therapy (CRRT). The solution is a premixed, electrolyte-balanced fluid containing phosphorus (as phosphate ions). Administration: Delivered via the replacement fluid port of the CRRT machine. Dose/Flow Rate: Standardized according to the study protocol (e.g., 25-35 mL/kg/h) to maintain hemodynamic stability and solute clearance. Duration: Expected intervention duration is 72 hours, with a maximum treatment period of up to 7 days, or until clinical termination of CRRT. Receives: Drug: Phosphate-containing Replacement Fluid
Control Group: Standard Phosphate-free Replacement Fluid	Sham comparator	Participants in this arm will receive a standard phosphate-free replacement fluid (Basal replacement solution) during Continuous Renal Replacement Therapy (CRRT). This solution contains standard electrolytes (Sodium, Potassium, Calcium, Magnesium, Chloride) and bicarbonate but lacks phosphate. Administration: Delivered via the replacement fluid port using the same CRRT equipment and settings as the experimental group. Dose/Flow Rate: Managed identically to the experimental group to ensure a comparable dialysis dose. Duration: Expected intervention duration is 72 hours, with a maximum treatment period of up to 7 days, or until clinical termination of CRRT. Receives: Drug: Standard Phosphate-free Replacement Fluid

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Serum Creatinine at 72 Hours
Percentage change in serum creatinine from baseline to 72 hours to evaluate the non-inferiority of the phosphate-containing fluid in solute clearance.
Measured: 72 hours
Incidence of Hypophosphatemia Within 72 Hours
Percentage of participants with any measured serum phosphorus < 0.81 mmol/L during the 72-hour treatment window.
Measured: Up to 72 hours

Secondary outcomes (17)

Percentage Change From Baseline in Serum Creatinine
The relative change in serum creatinine concentration compared to the baseline value. It is calculated as: [(Value at post-treatment visit - Baseline Value) / Baseline Value] x 100%.
Measured: Baseline, 24 hours, 48 hours, and 72 hours after CRRT initiation, and every 12-24 hours thereafter until the end of treatment (up to 7 days).
Sequential Organ Failure Assessment (SOFA) Score
The Sequential Organ Failure Assessment (SOFA) score is used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. The total score ranges from 0 to 24, with higher scores indicating more severe organ dysfunction.
Measured: Baseline, 24 hours, 48 hours, and 72 hours after CRRT initiation, and every 24 hours thereafter until the end of treatment (up to 7 days).
Total Amount of Exogenous Phosphorus Supplementation
The cumulative amount of exogenous phosphorus administered to participants to maintain serum phosphate levels within the target range.
Measured: Within 24 hours, 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Incidence of Exogenous Phosphorus Supplementation
The percentage of participants who required exogenous phosphorus supplementation during the CRRT procedure to maintain serum phosphorus levels within the target range. This measure evaluates the clinical demand for phosphorus replacement in both groups.
Measured: Within 24 hours, 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Change From Baseline in Serum Phosphorus Levels
The absolute change in serum phosphorus concentrations measured at each specified time point relative to the baseline value. This measure evaluates the stability of phosphate homeostasis during the CRRT procedure.
Measured: Baseline, 24 hours, 48 hours, and 72 hours after CRRT initiation, and every 24 hours thereafter until the end of treatment (up to 7 days).
Duration of Mechanical Ventilation During the Treatment Period
The cumulative number of hours the participant requires mechanical ventilation (including invasive and non-invasive). The measurement period starts from the initiation of CRRT and continues until 7 days after the cessation of CRRT treatment.
Measured: From the initiation of CRRT through 7 days after the completion of CRRT treatment.
Incidence of Hypophosphatemia (Excluding the 72-hour Primary Endpoint)
The percentage of participants who develop hypophosphatemia, defined as serum phosphorus levels below 0.81 mmol/L. This measure specifically tracks the occurrence within the first 24 hours, 48 hours, and throughout the entire treatment course to assess the early and overall safety profile, distinct from the primary endpoint assessed at 72 hours.
Measured: Within 24 hours, 48 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Duration of Hypophosphatemia
The cumulative duration (in hours) during which the participant's serum phosphorus level is below 0.81 mmol/L. The duration is calculated based on serial measurements: every 6 hours during the first 72 hours, and every 12 hours thereafter until the end of the treatment period.
Measured: Within the first 24 hours, 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Incidence of Hyperphosphatemia
The percentage of participants who develop hyperphosphatemia, defined as a serum phosphorus level above 1.45 mmol/L (or according to the institutional standard), at any time during the specified intervals.
Measured: Within the first 24 hours, 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Duration of Hyperphosphatemia
The cumulative duration (in hours) during which the participant's serum phosphorus level is above 1.45 mmol/L. The duration is calculated based on serial measurements: every 6 hours during the first 72 hours, and every 12 hours thereafter until the end of the treatment period.
Measured: Within 24 hours, 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Recovery Rate of Hyperphosphatemia
The percentage of participants with baseline hyperphosphatemia (serum phosphorus > 1.45 mmol/L) who achieve and maintain normal serum phosphorus levels (≤ 1.45 mmol/L) during specified intervals. Recovery is defined as phosphorus levels remaining ≤ 1.45 mmol/L consistently from 24 to 48 hours, 48 to 72 hours, and from 72 hours until the end of the treatment period (if treatment exceeds 72 hours).
Measured: 24 to 48 hours, 48 to 72 hours, and from 72 hours until the end of the treatment period (if treatment exceeds 72 hours).
Proportion of Participants With Normal Serum Phosphorus Levels
The percentage of participants whose serum phosphorus levels are within the normal range, defined as ≤ 1.45 mmol/L and ≥ 0.81 mmol/L. This measure is assessed once daily through laboratory monitoring.
Measured: At 48 hours, 72 hours after CRRT initiation, and every 24 hours thereafter until the end of treatment (up to 7 days).
Incidence of Hyperglycemia
The percentage of participants with baseline blood glucose < 10 mmol/L who develop hyperglycemia (defined as blood glucose ≥ 10 mmol/L) at any point during the specified time intervals. This measure evaluates the impact of the intervention on glycemic control.
Measured: Within 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Incidence of Hypoglycemia
The percentage of participants with baseline blood glucose ≥ 3.9 mmol/L who develop hypoglycemia (defined as blood glucose < 3.9 mmol/L) at any point during the specified time intervals. This measure is used to evaluate the metabolic safety of the intervention.
Measured: Within 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Incidence of Electrolyte and Acid-Base Deviations
The percentage of participants with electrolyte and acid-base values outside the clinical reference ranges for Sodium (Na+), Calcium (Ca2+), Magnesium (Mg2+), Chloride (Cl-), Bicarbonate (HCO3-), and pH. Deviations will be analyzed and reported separately as the proportion of participants with values below the lower limit of normal (LLN) and the proportion with values above the upper limit of normal (ULN) at each specified time point.
Measured: Baseline, 24 hours, 48 hours, 72 hours after CRRT initiation, and every 24 hours thereafter until the end of treatment (up to 7 days).
Incidence of Adverse Events
Percentage of participants experiencing at least one adverse event (AE). An AE is defined as any untoward medical occurrence, including worsening of pre-existing conditions, new clinical symptoms, signs, or clinically significant laboratory abnormalities, regardless of causal relationship with the study drug.
Note: Expected disease progression related to CRRT indications or comorbidities is not considered an AE unless it results in death or is more severe than expected. Notably, hypophosphatemia and hyperphosphatemia are reported separately and are NOT counted as AEs in this study.
Measured: From the initiation of CRRT through 7 days after the completion of CRRT treatment.
Incidence of Clinically Significant Abnormalities During the Treatment Period
The percentage of participants experiencing at least one clinically significant abnormal change in vital signs, 12-lead electrocardiograms (ECG), or laboratory parameters. "During the treatment period" is defined as the interval from the initiation of Continuous Renal Replacement Therapy (CRRT) until the cessation of the treatment.
Measured: From the initiation of CRRT until the end of CRRT treatment (up to 7 days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202630 Jun 2028

First posted24 Apr 2026
Study start1 May 2026 (estimated)
Primary completion31 Dec 2027 (estimated)
Study completion30 Jun 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a multicenter, randomized, double-blind, parallel-controlled, Phase III study. A total of 220 eligible participants will be randomized in a 1:1 ratio to either the experimental group (phosphate-containing replacement fluid) or the control group (standard phosphate-free fluid). Stratified Randomization: Randomization is managed via a central Interactive Web Response System (IWRS), stratified by: Baseline Serum Phosphorus: (\< 0.81 mmol/L; 0.81-1.45 mmol/L; \> 1.45 mmol/L). Baseline Serum Creatinine: (≥ 353 μmol/L; \< 353 μmol/L). Blinding Integrity: To maintain the double-blind design, the experimental and control fluids are provided in identical 4,000 mL bags with masked labeling. Participants, investigators, and outcome assessors remain blinded throughout the intervention period.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 220 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07550894
Sponsor's protocol ID: A1805-PL-LC-301
Acronym: PHOS-CRRT
Status last verified: Apr 2026
First submitted: 28 Mar 2026
Last updated: 24 Apr 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data (IPD) that underlie the results reported in the final publication, after de-identification (including demographic data, baseline clinical characteristics, and primary/secondary efficacy and safety outcomes), will be made available for sharing. This includes the analytic data set, the study protocol, and the statistical analysis plan. Data will be shared with qualified researchers who provide a methodologically sound proposal and have obtained ethical approval from their respective institutions. The purpose of the data sharing must be for secondary analysis to foster scientific advancement in critical care nutrition and phosphorus homeostasis.

Publications

Crowley KE, DeGrado JR, Charytan DM. Serum glucose and phosphorus concentrations during continuous renal replacement therapy using commercial replacement solutions with or without phosphorus. Hemodial Int. 2020 Jul;24(3):330-334. doi: 10.1111/hdi.12834. Epub 2020 Apr 29.
PubMed 32351011
Pistolesi V, Zeppilli L, Polistena F, Sacco MI, Pierucci A, Tritapepe L, Regolisti G, Fiaccadori E, Morabito S. Preventing Continuous Renal Replacement Therapy-Induced Hypophosphatemia: An Extended Clinical Experience with a Phosphate-Containing Solution in the Setting of Regional Citrate Anticoagulation. Blood Purif. 2017;44(1):8-15. doi: 10.1159/000453443. Epub 2017 Feb 21.
PubMed 28219057
Broman M, Carlsson O, Friberg H, Wieslander A, Godaly G. Phosphate-containing dialysis solution prevents hypophosphatemia during continuous renal replacement therapy. Acta Anaesthesiol Scand. 2011 Jan;55(1):39-45. doi: 10.1111/j.1399-6576.2010.02338.x. Epub 2010 Oct 29.
PubMed 21039362
Godaly G, Carlsson O, Broman M. Phoxilium((R)) reduces hypophosphataemia and magnesium supplementation during continuous renal replacement therapy. Clin Kidney J. 2016 Apr;9(2):205-10. doi: 10.1093/ckj/sfv133. Epub 2015 Dec 19.
PubMed 26985370
Pistolesi V, Zeppilli L, Fiaccadori E, Regolisti G, Tritapepe L, Morabito S. Hypophosphatemia in critically ill patients with acute kidney injury on renal replacement therapies. J Nephrol. 2019 Dec;32(6):895-908. doi: 10.1007/s40620-019-00648-5. Epub 2019 Sep 12.
PubMed 31515724
Lim C, Tan HK, Kaushik M. Hypophosphatemia in critically ill patients with acute kidney injury treated with hemodialysis is associated with adverse events. Clin Kidney J. 2017 Jun;10(3):341-347. doi: 10.1093/ckj/sfw120. Epub 2017 Jan 5.
PubMed 28616212
Hendrix RJ, Hastings MC, Samarin M, Hudson JQ. Predictors of Hypophosphatemia and Outcomes during Continuous Renal Replacement Therapy. Blood Purif. 2020;49(6):700-707. doi: 10.1159/000507421. Epub 2020 Apr 22.
PubMed 32320987
Demirjian S, Teo BW, Guzman JA, Heyka RJ, Paganini EP, Fissell WH, Schold JD, Schreiber MJ. Hypophosphatemia during continuous hemodialysis is associated with prolonged respiratory failure in patients with acute kidney injury. Nephrol Dial Transplant. 2011 Nov;26(11):3508-14. doi: 10.1093/ndt/gfr075. Epub 2011 Mar 7.
PubMed 21382993
Pasko DA, Mottes TA, Mueller BA. Pre dialysis of blood prime in continuous hemodialysis normalizes pH and electrolytes. Pediatr Nephrol. 2003 Nov;18(11):1177-83. doi: 10.1007/s00467-003-1258-2. Epub 2003 Oct 2.
PubMed 14523635
Yessayan L, Yee J, Frinak S, Szamosfalvi B. Continuous Renal Replacement Therapy for the Management of Acid-Base and Electrolyte Imbalances in Acute Kidney Injury. Adv Chronic Kidney Dis. 2016 May;23(3):203-10. doi: 10.1053/j.ackd.2016.02.005.
PubMed 27113697

Interested in taking part?

Jianfeng Wu, MD PhD

+86-20-87755766 ext 8454

wujianf@mail.sysu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Parallel-Controlled, Multicenter, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Phosphate-Containing Replacement Fluid in Continuous Renal Replacement Therapy
ClinicalTrials.gov ID: NCT07550894
Acronym / sponsor ID: PHOS-CRRT / A1805-PL-LC-301
Conditions: Acute Kidney Injury, Sepsis, Critically Ill Patients Requiring Continuous Renal Replacement Therapy
Keywords: CRRT, Phosphate-containing replacement fluid
Phase: Phase 3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 220 participants (estimated)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Collaborators: Chengdu Qingshan Likang Pharmaceutical Co., Ltd
Study start: 1 May 2026 (estimated)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 30 Jun 2028 (estimated)
First posted: 24 Apr 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

What are the main questions the study aims to answer?

Does the new fluid help keep phosphate at a healthy level in the blood during the first 72 hours of treatment?

How does the new fluid affect kidney function compared to the standard fluid?

Is the new fluid safe for patients to use?

Who can take part in this study?

The study is looking for adults (18 and older) who:

Are in the ICU and need CRRT treatment as decided by their doctor.

Are expected to need this treatment for at least 72 hours.

Are willing to participate (or have a legal guardian who agrees).

People who are pregnant, have known allergies to the fluid ingredients, or have very low blood pressure that cannot be corrected may not be able to join.

Participants will be put into one of two groups by a computer:

Group 1 (New Fluid): Receives the blood purification fluid that has phosphate already in it.

Group 2 (Standard Fluid): Receives the standard fluid that does not have phosphate.

What will participants have to do?

Receive Treatment: Participants will receive their assigned fluid during their normal CRRT care for up to 7 days.

Blood Tests: Doctors will take regular blood samples to check mineral levels and kidney health.

Monitoring: The medical team will closely watch participants for any side effects or safety concerns.

Follow-up: There will be a safety check-up 7 days after the treatment ends.

Detailed description

Scientific Rationale and Study Objective:

Study Design and Multicenter Implementation:

Blinding and Intervention Protocol:

Data Management and Quality Assurance:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: This is a multicenter, randomized, double-blind, parallel-controlled, Phase III study. A total of 220 eligible participants will be randomized in a 1:1 ratio to either the experimental group (phosphate-containing replacement fluid) or the control group (standard phosphate-free fluid). Stratified Randomization: Randomization is managed via a central Interactive Web Response System (IWRS), stratified by: Baseline Serum Phosphorus: (< 0.81 mmol/L; 0.81-1.45 mmol/L; > 1.45 mmol/L). Baseline Serum Creatinine: (≥ 353 μmol/L; < 353 μmol/L). Blinding Integrity: To maintain the double-blind design, the experimental and control fluids are provided in identical 4,000 mL bags with masked labeling. Participants, investigators, and outcome assessors remain blinded throughout the intervention period.

Arm	Type	Receives
Experimental Group: Phosphate-containing Replacement Fluid	Experimental	Drug: Phosphate-containing Replacement FluidParticipants in this arm will receive the phosphate-containing replacement fluid during Continuous Renal Replacement Therapy (CRRT). The solution is a premixed, electrolyte-balanced fluid containing phosphorus (as phosphate ions). Administration: Delivered via the replacement fluid port of the CRRT machine. Dose/Flow Rate: Standardized according to the study protocol (e.g., 25-35 mL/kg/h) to maintain hemodynamic stability and solute clearance. Duration: Expected intervention duration is 72 hours, with a maximum treatment period of up to 7 days, or until clinical termination of CRRT.
Control Group: Standard Phosphate-free Replacement Fluid	Sham comparator	Drug: Standard Phosphate-free Replacement FluidParticipants in this arm will receive a standard phosphate-free replacement fluid (Basal replacement solution) during Continuous Renal Replacement Therapy (CRRT). This solution contains standard electrolytes (Sodium, Potassium, Calcium, Magnesium, Chloride) and bicarbonate but lacks phosphate. Administration: Delivered via the replacement fluid port using the same CRRT equipment and settings as the experimental group. Dose/Flow Rate: Managed identically to the experimental group to ensure a comparable dialysis dose. Duration: Expected intervention duration is 72 hours, with a maximum treatment period of up to 7 days, or until clinical termination of CRRT.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Participants must meet all of the following criteria to be eligible for the study:

Key exclusion criteria (10 listed)

Participants meeting any of the following criteria will be excluded from the study:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Phosphate-containing Replacement FluidPhosphate-containing Replacement Fluid is an investigational Class 2.3 modified chemical drug approved by the NMPA (No. 2021LP00824). It is a premixed, electrolyte-balanced replacement fluid containing phosphorus. The solution is administered via the extracorporeal circuit during Continuous Renal Replacement Therapy (CRRT). The dosage and flow rate are standardized according to the subject's body weight and clinical requirements (typically 25-35 mL/kg/h).	Drug	Experimental Group: Phosphate-containing Replacement Fluid
Standard Phosphate-free Replacement FluidA marketed phosphate-free replacement fluid (standard of care). Administration via extracorporeal circuit with doses identical to the experimental group. Treatment is expected for 72 hours, up to a maximum of 7 days, or until CRRT is clinically terminated. This comparator evaluates the efficacy of the phosphate-containing solution in preventing treatment-induced hypophosphatemia.	Drug	Control Group: Standard Phosphate-free Replacement Fluid

Primary outcome

Change in Serum Creatinine at 72 Hours
Time frame: 72 hours
Percentage change in serum creatinine from baseline to 72 hours to evaluate the non-inferiority of the phosphate-containing fluid in solute clearance.
Incidence of Hypophosphatemia Within 72 Hours
Time frame: Up to 72 hours
Percentage of participants with any measured serum phosphorus < 0.81 mmol/L during the 72-hour treatment window.

17 secondary outcomes

Percentage Change From Baseline in Serum Creatinine
Time frame: Baseline, 24 hours, 48 hours, and 72 hours after CRRT initiation, and every 12-24 hours thereafter until the end of treatment (up to 7 days).
Sequential Organ Failure Assessment (SOFA) Score
Time frame: Baseline, 24 hours, 48 hours, and 72 hours after CRRT initiation, and every 24 hours thereafter until the end of treatment (up to 7 days).
Total Amount of Exogenous Phosphorus Supplementation
Time frame: Within 24 hours, 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Incidence of Exogenous Phosphorus Supplementation
Time frame: Within 24 hours, 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Change From Baseline in Serum Phosphorus Levels
Time frame: Baseline, 24 hours, 48 hours, and 72 hours after CRRT initiation, and every 24 hours thereafter until the end of treatment (up to 7 days).
Duration of Mechanical Ventilation During the Treatment Period
Time frame: From the initiation of CRRT through 7 days after the completion of CRRT treatment.
Incidence of Hypophosphatemia (Excluding the 72-hour Primary Endpoint)
Time frame: Within 24 hours, 48 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Duration of Hypophosphatemia
Time frame: Within the first 24 hours, 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Incidence of Hyperphosphatemia
Time frame: Within the first 24 hours, 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Duration of Hyperphosphatemia
Time frame: Within 24 hours, 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Recovery Rate of Hyperphosphatemia
Time frame: 24 to 48 hours, 48 to 72 hours, and from 72 hours until the end of the treatment period (if treatment exceeds 72 hours).
Proportion of Participants With Normal Serum Phosphorus Levels
Time frame: At 48 hours, 72 hours after CRRT initiation, and every 24 hours thereafter until the end of treatment (up to 7 days).
Incidence of Hyperglycemia
Time frame: Within 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Incidence of Hypoglycemia
Time frame: Within 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Incidence of Electrolyte and Acid-Base Deviations
Time frame: Baseline, 24 hours, 48 hours, 72 hours after CRRT initiation, and every 24 hours thereafter until the end of treatment (up to 7 days).
Incidence of Adverse Events
Time frame: From the initiation of CRRT through 7 days after the completion of CRRT treatment.
Incidence of Clinically Significant Abnormalities During the Treatment Period
Time frame: From the initiation of CRRT until the end of CRRT treatment (up to 7 days).

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
Results publication: PubMed 32351011Crowley KE, DeGrado JR, Charytan DM. Serum glucose and phosphorus concentrations during continuous renal replacement therapy using commercial replacement solutions with or without phosphorus. Hemodial Int. 2020 Jul;24(3):330-334. doi: 10.1111/hdi.12834. Epub 2020 Apr 29.
Results publication: PubMed 28219057Pistolesi V, Zeppilli L, Polistena F, Sacco MI, Pierucci A, Tritapepe L, Regolisti G, Fiaccadori E, Morabito S. Preventing Continuous Renal Replacement Therapy-Induced Hypophosphatemia: An Extended Clinical Experience with a Phosphate-Containing Solution in the Setting of Regional Citrate Anticoagulation. Blood Purif. 2017;44(1):8-15. doi: 10.1159/000453443. Epub 2017 Feb 21.
Results publication: PubMed 21039362Broman M, Carlsson O, Friberg H, Wieslander A, Godaly G. Phosphate-containing dialysis solution prevents hypophosphatemia during continuous renal replacement therapy. Acta Anaesthesiol Scand. 2011 Jan;55(1):39-45. doi: 10.1111/j.1399-6576.2010.02338.x. Epub 2010 Oct 29.
Results publication: PubMed 26985370Godaly G, Carlsson O, Broman M. Phoxilium((R)) reduces hypophosphataemia and magnesium supplementation during continuous renal replacement therapy. Clin Kidney J. 2016 Apr;9(2):205-10. doi: 10.1093/ckj/sfv133. Epub 2015 Dec 19.
Results publication: PubMed 31515724Pistolesi V, Zeppilli L, Fiaccadori E, Regolisti G, Tritapepe L, Morabito S. Hypophosphatemia in critically ill patients with acute kidney injury on renal replacement therapies. J Nephrol. 2019 Dec;32(6):895-908. doi: 10.1007/s40620-019-00648-5. Epub 2019 Sep 12.
Results publication: PubMed 28616212Lim C, Tan HK, Kaushik M. Hypophosphatemia in critically ill patients with acute kidney injury treated with hemodialysis is associated with adverse events. Clin Kidney J. 2017 Jun;10(3):341-347. doi: 10.1093/ckj/sfw120. Epub 2017 Jan 5.
Results publication: PubMed 32320987Hendrix RJ, Hastings MC, Samarin M, Hudson JQ. Predictors of Hypophosphatemia and Outcomes during Continuous Renal Replacement Therapy. Blood Purif. 2020;49(6):700-707. doi: 10.1159/000507421. Epub 2020 Apr 22.
Results publication: PubMed 21382993Demirjian S, Teo BW, Guzman JA, Heyka RJ, Paganini EP, Fissell WH, Schold JD, Schreiber MJ. Hypophosphatemia during continuous hemodialysis is associated with prolonged respiratory failure in patients with acute kidney injury. Nephrol Dial Transplant. 2011 Nov;26(11):3508-14. doi: 10.1093/ndt/gfr075. Epub 2011 Mar 7.
Results publication: PubMed 14523635Pasko DA, Mottes TA, Mueller BA. Pre dialysis of blood prime in continuous hemodialysis normalizes pH and electrolytes. Pediatr Nephrol. 2003 Nov;18(11):1177-83. doi: 10.1007/s00467-003-1258-2. Epub 2003 Oct 2.
Results publication: PubMed 27113697Yessayan L, Yee J, Frinak S, Szamosfalvi B. Continuous Renal Replacement Therapy for the Management of Acid-Base and Electrolyte Imbalances in Acute Kidney Injury. Adv Chronic Kidney Dis. 2016 May;23(3):203-10. doi: 10.1053/j.ackd.2016.02.005.
Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in the final publication, after de-identification (including demographic data, baseline clinical characteristics, and primary/secondary efficacy and safety outcomes), will be made available for sharing. This includes the analytic data set, the study protocol, and the statistical analysis plan. Data will be shared with qualified researchers who provide a methodologically sound proposal and have obtained ethical approval from their respective institutions. The purpose of the data sharing must be for secondary analysis to foster scientific advancement in critical care nutrition and phosphorus homeostasis.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Jianfeng Wu, MD PhD contact

+86-20-87755766 ext 8454

wujianf@mail.sysu.edu.cn

Chuanxi Chen, MD PhD contact

+86-20-87755766 ext 8454

chenchx23@mail.sysu.edu.cn

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jianfeng Wu, MD PhD (+86-20-87755766 ext 8454, wujianf@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Serum Creatinine at 72 Hours (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07550894, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.