SAfety of Regional Citrate Anticoagulation (SARCA Study)

NCT05339139 | Recruiting Phase 3 FDA Drug FDA Device

• 1 other identifier: Ci-Ca-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 10

Brief 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).

Conditions

Acute Kidney Injury; ESRD

Outcome Measures

Primary Outcomes (6)

• 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.

  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

  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

  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

  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.

  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: 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.

  Up to 1 month

Secondary Outcomes (1)

• Circuit life

  The life of a circuit is 72 hrs and then it needs to be replaced . Subject participation is upto 1 month.

Other Outcomes (1)

• Adverse Events

  through study completion, an average of 1 year

Study Arms (1)

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

Combination Product: Dialysis

Interventions

Dialysis COMBINATION_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.

Ci-Ca Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Medical Care North America: lead

Study Sites (10)

John L. McClellan Memorial Veterans' Hospital

Little Rock, Arkansas, 72205, United States

COMPLETED

University of Arkansas for Medical Sciences (UAMS)

Little Rock, Arkansas, 72205, United States

RECRUITING

Advent Health Orlando

Orlando, Florida, 32803, United States

NOT YET RECRUITING

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109-5000, United States

COMPLETED

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

COMPLETED

University of Mississippi Medical Center

Jackson, Mississippi, 39350, United States

RECRUITING

Washington University - Hospital

St Louis, Missouri, 63110, United States

COMPLETED

Intermountain Health

Murray, Utah, 84107, United States

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Kidney Failure, Chronic

Interventions

Dialysis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena

Study Officials

• Manuela Stauss-Grabo, PhD

  Fresenius Medical Care North America

  STUDY DIRECTOR

Central Study Contacts

Anja Derlet-Savoia, PhD

CONTACT

+49 173 965 9356; anja.derlet@freseniusmedicalcare.com

Manuela Stauss-Grabo, PhD

CONTACT

+49 1525 469 1929; manuela.stauss-grabo1@freseniusmedicalcare.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 21, 2022
• Study Start: October 17, 2023
• Primary Completion: April 30, 2025
• Study Completion: July 31, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

US (10)