Acute Kidney InjuryPhase 3SARCANCT05339139
SAfety of Regional Citrate Anticoagulation (SARCA Study)
A Phase 3 study testing Dialysis in people with Acute Kidney Injury and ESRD, run by Fresenius Medical Care North America at 10 sites in United States.
Trial summary
This is an Open-label, Prospective, Multicenter Study to Assess the SAfety of Regional Citrate Anticoagulation Delivered by the multiFiltratePRO system in Adult Patients Requiring Continuous Renal Replacement Therapy (SARCA Study). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, ESRD
- What is being tested?
- Dialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 10 sitesUnited States
- Study dates
- 17 Oct 2023to 30 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form by
- The subject or
- A legally authorized representative (LAR), if the subject is unable to consent
- Adult patients ≥ 18 years old
- Diagnosis of AKI or End-Stage Kidney Disease (ESKD) requiring CRRT
- Vascular access - Dialysis Catheter with size and location per institutional practice
Who cannot join
- Metabolic alkalosis as defined by serum bicarbonate greater than 30 mmol/L and arterial pH greater than 7.55
- A female who is pregnant or breast feeding
- Severe liver disease defined as International Normalized Ratio (INR) greater than 2.0 and total bilirubin greater than 5 mg/dl, and both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than 3 times upper limit of normal
- Subjects currently enrolled in or who have completed any other investigational drug or device study within last 30 days prior to signing informed consent
- Previous participation in a similar or the same study.
- Subjects already on continuous renal replacement therapy
- Subjects with active COVID-19 infection
- Subjects cannot tolerate citrate therapy defined as severe liver disease (see exclusion criteria #3), shock with muscle hypoperfusion and known hypersensitivity to citrate
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Michigan
Ann Arbor, Michigan, 48109-5000
Henry Ford Hospital
Detroit, Michigan, 48202
University of Mississippi Medical Center
Jackson, Mississippi, 39350
John L. McClellan Memorial Veterans' Hospital
Little Rock, Arkansas, 72205
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, 72205
Intermountain Health
Murray, Utah, 84107
Advent Health Orlando
Orlando, Florida, 32803
Mayo Clinic
Rochester, Minnesota, 55905
Washington University - Hospital
St Louis, Missouri, 63110
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: An Open-label, Prospective, Multicenter Study to Assess the SAfety of Regional Citrate Anticoagulation Delivered by the multiFiltratePRO System in Adult Patients Requiring Continuous Renal Replacement Therapy (SARCA Study)
This is an Open-label, Prospective, Multicenter Study to Assess the SAfety of Regional Citrate Anticoagulation Delivered by the multiFiltratePRO system in Adult Patients Requiring Continuous Renal Replacement Therapy (SARCA Study).
Read the detailed description
In short, AKI is a major complication in intensive care patients, often occurring in the context of multiple organ failure, and some of these patients may need CRRT. The major advantage of CRRT is improved hemodynamic stability compared to intermittent HD. Continuous anticoagulation during CRRT may be needed to prevent premature clotting of the circuit and deliver the prescribed dialysis dose. Unfractionated heparin is the most commonly used anticoagulation during CRRT mainly as a result of familiarity, low cost, and ease of administration. But the main drawback is the risk of bleeding.
An alternative technique to avoid systemic anticoagulation is regional extracorporeal anticoagulation with citrate (RCA). The advantages of RCA are improved circuit patency and fewer bleeding complications. The use of RCA may also reduce the ICU staff workload. Studies have shown longer filter running times which reduced circuit change and set-up time. In addition, anticoagulation related bleeding, and CRRT-related blood transfusions were minimized. Therefore, CRRT with RCA might be more economical than conventional anticoagulation.
The study is to explore the possibility of using the multiFiltrate PRO system with the Ci-Ca module, Cifoban® (Trisodium citrate 4%), Calrecia® (Calcium chloride dihydrate), Ci-Ca dialysate K2 and K4, AV1000 (disposable cassette), and multiBic solution in subjects who are critically ill and receiving CRRT in an acute setting.
- Conditions
- Acute Kidney Injury, ESRD
- Being tested
- Dialysis
- Medical subject headings
- Acute Kidney Injury, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DialysisCombination product
In this study critically ill adult patients requiring Continuous Renal Replacement Therapy (CRRT) will receive Regional Citrate Anticoagulation (CRA) which will be delivered by multiFiltratePRO system.
| Study group | Role | What they receive |
|---|---|---|
| Ci-Ca Arm | Experimental | The study population will include critically ill subjects who are a minimum of 18 years old, in an acute setting, requiring CRRT. the Subjects will receive Regional Citrate Anticoagulation (RCA) which will be delivered by MultiFiltiratePRO system Receives: Combination Product: Dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms and systemic ionized calcium level
Defined as a symptomatic episode of delirium, coma, nausea, vomiting, constipation, muscle weakness, hypertension, bradycardia, deemed attributable to hypercalcemia with a confirmed systemic ionized calcium > 1.5mmol/L.
Measured: Up to 1 month
Arterial pH measure and bicarbonate level
Arterial pH > 7.55 and bicarbonate > 30 mmol/L in the absence of exogenous bicarbonate administered
Measured: Up to 1 month
Serum sodium (Na) level
Serum sodium (Na) level > 150 mmol/L and > 5 mmol/L rise in systemic Na above the prescribed CRRT fluids. Na level in the absence of hypertonic intravenous Na infusion
Measured: Up to 1 month
Drop in hemoglobin (Hgb)
Bleeding resulting in more than 2 g/dL drop in hemoglobin (Hgb) in 24-hour period or need for transfusion
Measured: Up to 1 month
Symptoms and systemic ionized calcium level
defined as a symptomatic episode of tetany/spasms, seizures, deemed attributable to hypocalcemia and with a confirmed systemic iCa < 0.85 mmol/L.
Measured: Up to 1 month
Symptoms and total-to-ionized calcium ratio
Patients with impaired citrate metabolism or citrate overdose can exhibit citrate accumulation. Symptomatic citrate accumulation presents with symptoms of tetany/spasms, seizures, systemic hypocoagulability, hypotension, or cardiac events; and should be confirmed with:
- A total-to-ionized calcium ratio > 2.5; OR
- A total-to-ionized calcium ratio greater than 2.25 together with one or more of the following criteria:
- an increase in calcium supplementation,
- decreasing systemic ionized calcium, and
- metabolic acidosis. When a clinical presentation is possibly associated with an abnormal concentration of systemic ionized calcium or an altered acid-base balance, the labs ({Calcium: systemic ionized calcium, post-filter ionized calcium and total calcium}, bicarbonate, sodium, potassium, magnesium, phosphate) should be checked immediately.
Measured: Up to 1 month
Secondary outcomes (1)
Circuit life
Circuit life is defined by time to circuit replacement
Measured: The life of a circuit is 72 hrs and then it needs to be replaced . Subject participation is upto 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start17 Oct 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open label, prospective, single-arm, multicenter study with adult patients requiring CRRT. In this study, the subjects will receive CRRT on the mFTPRO system with RCA. RCA treatment should be used until the end of CRRT. The circuit needs to be replaced after 72 hours of running time.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care North America
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manuela Stauss-Grabo, PhD, Study director, Fresenius Medical Care North America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339139
- Sponsor's protocol ID
- Ci-Ca-001
- Acronym
- SARCA
- Status last verified
- Sep 2026
- First submitted
- 8 Apr 2022
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Prospective, Multicenter Study to Assess the SAfety of Regional Citrate Anticoagulation Delivered by the multiFiltratePRO System in Adult Patients Requiring Continuous Renal Replacement Therapy (SARCA Study)
- ClinicalTrials.gov ID
- NCT05339139
- Acronym / sponsor ID
- SARCA / Ci-Ca-001
- Conditions
- Acute Kidney Injury, ESRD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Fresenius Medical Care North AmericaIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 21 Apr 2022 (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.
This is an Open-label, Prospective, Multicenter Study to Assess the SAfety of Regional Citrate Anticoagulation Delivered by the multiFiltratePRO system in Adult Patients Requiring Continuous Renal Replacement Therapy (SARCA Study).
Detailed description
In short, AKI is a major complication in intensive care patients, often occurring in the context of multiple organ failure, and some of these patients may need CRRT. The major advantage of CRRT is improved hemodynamic stability compared to intermittent HD. Continuous anticoagulation during CRRT may be needed to prevent premature clotting of the circuit and deliver the prescribed dialysis dose. Unfractionated heparin is the most commonly used anticoagulation during CRRT mainly as a result of familiarity, low cost, and ease of administration. But the main drawback is the risk of bleeding.
An alternative technique to avoid systemic anticoagulation is regional extracorporeal anticoagulation with citrate (RCA). The advantages of RCA are improved circuit patency and fewer bleeding complications. The use of RCA may also reduce the ICU staff workload. Studies have shown longer filter running times which reduced circuit change and set-up time. In addition, anticoagulation related bleeding, and CRRT-related blood transfusions were minimized. Therefore, CRRT with RCA might be more economical than conventional anticoagulation.
The study is to explore the possibility of using the multiFiltrate PRO system with the Ci-Ca module, Cifoban® (Trisodium citrate 4%), Calrecia® (Calcium chloride dihydrate), Ci-Ca dialysate K2 and K4, AV1000 (disposable cassette), and multiBic solution in subjects who are critically ill and receiving CRRT in an acute setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open label, prospective, single-arm, multicenter study with adult patients requiring CRRT. In this study, the subjects will receive CRRT on the mFTPRO system with RCA. RCA treatment should be used until the end of CRRT. The circuit needs to be replaced after 72 hours of running time.
| Arm | Type | Receives |
|---|---|---|
| Ci-Ca Arm | Experimental | Combination Product: DialysisThe study population will include critically ill subjects who are a minimum of 18 years old, in an acute setting, requiring CRRT. the Subjects will receive Regional Citrate Anticoagulation (RCA) which will be delivered by MultiFiltiratePRO system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent form by
- Adult patients ≥ 18 years old
- Diagnosis of AKI or End-Stage Kidney Disease (ESKD) requiring CRRT
- Vascular access - Dialysis Catheter with size and location per institutional practice
Key exclusion criteria (8 listed)
- Metabolic alkalosis as defined by serum bicarbonate greater than 30 mmol/L and arterial pH greater than 7.55
- A female who is pregnant or breast feeding
- Severe liver disease defined as International Normalized Ratio (INR) greater than 2.0 and total bilirubin greater than 5 mg/dl, and both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than 3 times upper limit of normal
- Subjects currently enrolled in or who have completed any other investigational drug or device study within last 30 days prior to signing informed consent
- Previous participation in a similar or the same 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 |
|---|---|---|
| DialysisIn this study critically ill adult patients requiring Continuous Renal Replacement Therapy (CRRT) will receive Regional Citrate Anticoagulation (CRA) which will be delivered by multiFiltratePRO system. | Combination product | Ci-Ca Arm |
Primary outcome
Symptoms and systemic ionized calcium level
Time frame: Up to 1 month
Defined as a symptomatic episode of delirium, coma, nausea, vomiting, constipation, muscle weakness, hypertension, bradycardia, deemed attributable to hypercalcemia with a confirmed systemic ionized calcium > 1.5mmol/L.
Arterial pH measure and bicarbonate level
Time frame: Up to 1 month
Arterial pH > 7.55 and bicarbonate > 30 mmol/L in the absence of exogenous bicarbonate administered
Serum sodium (Na) level
Time frame: Up to 1 month
Serum sodium (Na) level > 150 mmol/L and > 5 mmol/L rise in systemic Na above the prescribed CRRT fluids. Na level in the absence of hypertonic intravenous Na infusion
Drop in hemoglobin (Hgb)
Time frame: Up to 1 month
Bleeding resulting in more than 2 g/dL drop in hemoglobin (Hgb) in 24-hour period or need for transfusion
Symptoms and systemic ionized calcium level
Time frame: Up to 1 month
defined as a symptomatic episode of tetany/spasms, seizures, deemed attributable to hypocalcemia and with a confirmed systemic iCa < 0.85 mmol/L.
Symptoms and total-to-ionized calcium ratio
Time frame: Up to 1 month
Patients with impaired citrate metabolism or citrate overdose can exhibit citrate accumulation. Symptomatic citrate accumulation presents with symptoms of tetany/spasms, seizures, systemic hypocoagulability, hypotension, or cardiac events; and should be confirmed with: 1. A total-to-ionized calcium ratio > 2.5; OR 2. A total-to-ionized calcium ratio greater than 2.25 together with one or more of the following criteria: 1. an increase in calcium supplementation, 2. decreasing systemic ionized calcium, and 3. metabolic acidosis. When a clinical presentation is possibly associated with an abnormal concentration of systemic ionized calcium or an altered acid-base balance, the labs ({Calcium: systemic ionized calcium, post-filter ionized calcium and total calcium}, bicarbonate, sodium, potassium, magnesium, phosphate) should be checked immediately.
1 secondary outcome
Circuit life
Time frame: The life of a circuit is 72 hrs and then it needs to be replaced . Subject participation is upto 1 month.
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 11 Sep 2026.
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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. This study is not recruiting at the moment.
Manuela Stauss-Grabo, PhD study director
Fresenius Medical Care North America
10 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 Dialysis in people with Acute Kidney Injury and ESRD, run by Fresenius Medical Care North America at 10 sites in United States.
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 8 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
Symptoms and systemic ionized calcium level (time frame: Up to 1 month). The study lists 6 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 11 Sep 2026.