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Dialysis

Phase 3

Acute Kidney Injury | Small molecule | Nephrology |Fresenius Medical Care AG|Last Updated: Apr 24, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05339139SAfety of Regional Citrate Anticoagulation (SARCA Study)PHASE3 RECRUITING 50Oct 17, 2023Jul 31, 2025Apr 24, 202510 United States
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Study Endpoints
Primary Endpoints
Symptoms and systemic ionized calcium level
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
Up to 1 month

Arterial pH \> 7.55 and bicarbonate \> 30 mmol/L in the absence of exogenous bicarbonate administered

Serum sodium (Na) level
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)
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 total-to-ionized calcium ratio
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.

Secondary Endpoints
Circuit life
The life of a circuit is 72 hrs and then it needs to be replaced . Subject participation is upto 1 month.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Ci-Ca ArmEXPERIMENTALThe 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
Interventions
NameTypeDescription
DialysisCOMBINATION_PRODUCTIn 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.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: 1. Signed informed consent form by * The subject or * A legally authorized representative (LAR), if the subject is unable to consent 2. Adult patients ≥ 18 years old 3. Diagnosis of AKI or End-Stage Kidney Disease (ESKD) requiring CRRT 4. Vascular access - Dialysis Cathet...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05339139primaryCompletionDate: changed
LOWMay 24, 2026NCT05339139studyFirstPostDate: changed