Maintenance HemodialysisPhase 3NCT03861247
Individualized Treatment of Hyperphosphatemia in Maintenance Hemodialysis Patients
A Phase 3 study testing Phosphate-binder intervention and Phosphorus-restricted dietary intervention in people with Maintenance Hemodialysis and Hyperphosphatemia, run by Chen Jing at 2 sites in China.
Trial summary
The research is designed as a prospective, randomized, controlled clinical trial without blinding. A total of 116 participants with hyperphosphatemia will be enrolled from three hemodialysis center (56 from Huashan Hospital, 30 from Huadong Hospital and 30 from Tongji Hospital). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Maintenance Hemodialysis, Hyperphosphatemia
- What is being tested?
- Phosphate-binder intervention and Phosphorus-restricted dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 2 sitesChina
- Study dates
- 29 Nov 2019to 15 Apr 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject within 18-85 years old, male or female.
- Subject receiving maintenance hemodialysis 3 times weekly at least 3 months with autologous arteriovenous fistula.
- Subject with hyperphosphatemia as defined by serum phosphorus concentration >1.45mmol/L.
- Subject in a good general condition with a stable dietary habit.
- Subject has insight of the disease and treatment himself/herself and haves ability to communicate with others.
- Subject has provided informed consent.
Who cannot join
- Subject has residual renal function.
- Subject with severe infection, anemia (Hb<60g/L) or hypoproteinemia (Alb<30g/L).
- Subject has cancer or cachexia.
- Subject with a history of myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 3 months.
- Subject with severe hematopoietic system disease, such as aplastic anemia, thalassemia and thrombocytopenic purpura.
- Subject with severe gastrointestinal system disease such as dysphagia, hypohepatia, Active gastrointestinal bleeding, ileus, enterobrosis, or received subtotal gastrectomy.
Show all 12Show fewer
- Subject with disease which affects serum phosphorus concentration such as hypoparathyroidism (iPTH<11pg/ml), severe hyperparathyroidism (iPTH>600pg/ml) and type 2 vitamin D dependence rickets.
- Subject is pregnant.
- Subject is currently enrolled in or has completed any other investigational device or drug study<30 days prior to screening, or is receiving other investigational agents.
- Subject has inadequate hemodialysis with a recent spKt/V<1.2.
- Subject has a poor nutritional status with a recent (nPNA<1.0g/kg/d) .
- Subject is not a good participant for the research in the opinion of the investigator.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Huadong Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
Tongji Hospital, Tongji University
Shanghai, Shanghai Municipality, 200000
About this study
Official title: Individualized Treatment of Hyperphosphatemia Based on Phosphate Balance in Maintenance Hemodialysis Patients: a Multicenter, Randomized Clinical Trial
The research is designed as a prospective, randomized, controlled clinical trial without blinding. A total of 116 participants with hyperphosphatemia will be enrolled from three hemodialysis center (56 from Huashan Hospital, 30 from Huadong Hospital and 30 from Tongji Hospital). All participants will be randomly divided into control group and intervention group in a ratio of 1:1. Phosphorus balance status is evaluated in participants of the intervention group by the phosphorus balance calculator. Then, these participants will be given individualized phosphate-binders, dietary and dialysis intervention according to the results of phosphorus balance evaluation. Participants in the control group will not receive the phosphorus balance status evaluation but receive phosphate-binder treatment according to the KDIGO Guidelines. Dietary phosphorus intake, dialysate calcium concentration and dose of active vitamin D, phosphorus-binders of all participants will be recorded during the whole research program. After two-week treatment, the phosphorus balance of participants in intervention group will be evaluated again and the therapeutic strategies then will be adjusted. At the same time, the therapeutic strategies of participants in the control group will be adjusted according to the serum phosphorus concentration. All participants will be followed up for two weeks again and receive blood test and related examinations at the end of study. The results of final examinations will be analyzed to evaluate the efficacy of individualized treatment of hyperphosphatemia.
- Conditions
- Maintenance Hemodialysis, Hyperphosphatemia
- Being tested
- Phosphate-binder intervention, Phosphorus-restricted dietary intervention
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phosphate-binder interventionDrug
Use phosphate-binders according to KDIGO Guidelines, Chinese Guidance for Diagnosis and Treatment of Mineral and Bone Disorder in Chronic Kidney Disease and drug specification .
Phosphorus-restricted dietary interventionDietary supplement
Also called Additional dialysis intervention
Use low phosphorus diet and prolong the time of hemodialysis according to the phosphorus balance evaluation if necessary
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Not described Receives: Drug: Phosphate-binder intervention |
| Intervention group | Experimental | Not described Receives: Drug: Phosphate-binder intervention; Dietary Supplement: Phosphorus-restricted dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum phosphorus concentration
Measured: Four weeks after treatment
Achievement rate of serum phosphorus
Measured: Four weeks after treatment
Secondary outcomes (3)
Serum calcium concentration
Measured: Four weeks after treatment
Serum iPTH concentration
Measured: Four weeks after treatment
Serum albumin concentration
Measured: Four weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start29 Nov 2019
- Primary completion3 Jan 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maintenance HemodialysisStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chen Jing
- Sponsor type
- University, hospital or other
- Collaborators
- Huadong Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine
- Responsible party
- Sponsor-investigator, Chen Jing, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861247
- Sponsor's protocol ID
- KY-2018470
- Status last verified
- Aug 2021
- First submitted
- 28 Feb 2019
- Last updated
- 31 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Treatment of Hyperphosphatemia Based on Phosphate Balance in Maintenance Hemodialysis Patients: a Multicenter, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03861247
- Acronym / sponsor ID
- KY-2018470
- Conditions
- Maintenance Hemodialysis, Hyperphosphatemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Chen JingUniversity, hospital or other
- Collaborators
- Huadong Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine
- Study start
- 29 Nov 2019 (actual)
- Primary completion
- 3 Jan 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 4 Mar 2019 (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.
The research is designed as a prospective, randomized, controlled clinical trial without blinding. A total of 116 participants with hyperphosphatemia will be enrolled from three hemodialysis center (56 from Huashan Hospital, 30 from Huadong Hospital and 30 from Tongji Hospital). All participants will be randomly divided into control group and intervention group in a ratio of 1:1. Phosphorus balance status is evaluated in participants of the intervention group by the phosphorus balance calculator. Then, these participants will be given individualized phosphate-binders, dietary and dialysis intervention according to the results of phosphorus balance evaluation. Participants in the control group will not receive the phosphorus balance status evaluation but receive phosphate-binder treatment according to the KDIGO Guidelines. Dietary phosphorus intake, dialysate calcium concentration and dose of active vitamin D, phosphorus-binders of all participants will be recorded during the whole research program. After two-week treatment, the phosphorus balance of participants in intervention group will be evaluated again and the therapeutic strategies then will be adjusted. At the same time, the therapeutic strategies of participants in the control group will be adjusted according to the serum phosphorus concentration. All participants will be followed up for two weeks again and receive blood test and related examinations at the end of study. The results of final examinations will be analyzed to evaluate the efficacy of individualized treatment of hyperphosphatemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Phosphate-binder intervention |
| Intervention group | Experimental | Drug: Phosphate-binder intervention, Dietary Supplement: Phosphorus-restricted dietary intervention |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject within 18-85 years old, male or female.
- Subject receiving maintenance hemodialysis 3 times weekly at least 3 months with autologous arteriovenous fistula.
- Subject with hyperphosphatemia as defined by serum phosphorus concentration >1.45mmol/L.
- Subject in a good general condition with a stable dietary habit.
- Subject has insight of the disease and treatment himself/herself and haves ability to communicate with others.
Key exclusion criteria (12 listed)
- Subject has residual renal function.
- Subject with severe infection, anemia (Hb<60g/L) or hypoproteinemia (Alb<30g/L).
- Subject has cancer or cachexia.
- Subject with a history of myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 3 months.
- Subject with severe hematopoietic system disease, such as aplastic anemia, thalassemia and thrombocytopenic purpura.
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-binder interventionUse phosphate-binders according to KDIGO Guidelines, Chinese Guidance for Diagnosis and Treatment of Mineral and Bone Disorder in Chronic Kidney Disease and drug specification . | Drug | Control group, Intervention group |
| Phosphorus-restricted dietary interventionAlso: Additional dialysis interventionUse low phosphorus diet and prolong the time of hemodialysis according to the phosphorus balance evaluation if necessary | Dietary supplement | Intervention group |
Primary outcome
Serum phosphorus concentration
Time frame: Four weeks after treatment
Achievement rate of serum phosphorus
Time frame: Four weeks after treatment
3 secondary outcomes
Serum calcium concentration
Time frame: Four weeks after treatment
Serum iPTH concentration
Time frame: Four weeks after treatment
Serum albumin concentration
Time frame: Four weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Maintenance Hemodialysis
Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Not yet recruitingObservational study
Tenapanor in Maintenance Hemodialysis Patients
Hyperphosphatemia, Maintenance Hemodialysis
Recruiting
Trial of Variable Dialysate Bicarbonate
Peri-dialytic Cardiac Rhythms, Intradialytic Hypotension
Recruiting
Prospective, Multicentre, Randomized, Controlled, Cross-over Study on the Safety and Performance of the Biologic Fusion Option of DialogiQ Compared to Haemodialysis Without Biologic Fusion in Hypotension Prone Patients on Maintenance Haemodialysis
Renal Dialysis
Not yet recruitingObservational study
Twice vs Thrice Weekly Hemodialysis: Clinical Outcomes and Quality of Life
Kidney Failure, Chronic, Quality of Life
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phosphate-binder intervention and Phosphorus-restricted dietary intervention in people with Maintenance Hemodialysis and Hyperphosphatemia, run by Chen Jing at 2 sites in China.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum phosphorus concentration (time frame: Four weeks after treatment). 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?
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 31 Aug 2021.