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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Fresenius Medical Care AG Sponsored ADR | FMS | 1 | PHASE3 | Dialysis |
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| Talphera, Inc. | TLPH | 1 | N/A | Undisclosed |
| SeaStar Medical Holding Corporation | ICU | 2 | - | Undisclosed |
| Collegium Pharmaceutical, Inc. | COLL | 1 | - | Flozin |
Dialysis is an extracorporeal blood purification therapy used in Acute Kidney Injury to remove waste products and excess fluid when the kidneys can no longer perform these functions. It is being studied as a treatment for patients with Acute Kidney Injury and End-Stage Renal Disease, with the goal of providing renal replacement support.
Dialysis is developed by Fresenius Medical Care AG, a company publicly traded under the ticker symbol FMS. Fresenius Medical Care is a global healthcare company specializing in kidney care, including dialysis products and services.
Dialysis is currently in Phase 3 clinical development as an investigational therapy for Acute Kidney Injury. It is not yet approved by regulatory authorities and remains under investigation in an active clinical trial.
Dialysis is being evaluated in the SARCA Study (NCT05339139), a Phase 3 trial titled 'SAfety of Regional Citrate Anticoagulation'. This single-center, uncontrolled study is recruiting 50 participants aged 18 and older in the United States with Acute Kidney Injury or End-Stage Renal Disease.
The Phase 3 clinical trial of Dialysis, NCT05339139, is neither randomized nor double-blind. It is an uncontrolled study, meaning there is no comparator arm, and both patients and investigators are aware of the treatment being administered.