Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dialysis · 1 trial · 2 indications
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 \> 7.55 and bicarbonate \> 30 mmol/L in the absence of exogenous bicarbonate administered
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
Bleeding resulting in more than 2 g/dL drop in hemoglobin (Hgb) in 24-hour period or need for transfusion
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
| Name | Type | Description |
|---|---|---|
| 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. |
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...
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
Dialysis is a small molecule therapy being developed for acute kidney injury, a condition in which the kidneys suddenly lose their ability to filter waste from the blood. It is also being studied in end-stage renal disease. The program is in Phase 3 development and is not approved.
Dialysis is being developed by Fresenius Medical Care AG, which trades under the ticker FMS. The company is the sponsor of the clinical program evaluating this therapy in nephrology indications, including acute kidney injury and end-stage renal disease.
Dialysis is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The program remains investigational and has not been approved for commercial use in acute kidney injury or any other indication.
Dialysis has been evaluated in one completed Phase 3 trial, NCT05339139, titled SAfety of Regional Citrate Anticoagulation (SARCA Study). The study enrolled 32 participants aged 18 years and older in the United States and included patients with acute kidney injury and end-stage renal disease.
No. The SARCA study, NCT05339139, was an uncontrolled trial with no randomization and no double blinding. It enrolled 32 participants and has been completed. The study was not biomarker selected and did not include healthy volunteers.