Approval Probability
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Adjusted LOA
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Neutrolin · 1 trial · 2 indications
CRBSI was defined as the same organism grown from at least one positive blood culture from a peripheral site or bloodline sample, or either the arterial or venous catheter hub. The final assessment of CRBSI was determined by a Clinical Adjudication Committee (CAC) who used both clinical documentation and blood culture results in their assessment.
| Arm | Type | Description |
|---|---|---|
| Neutrolin arm | EXPERIMENTAL | Neutrolin: Neutrolin will be added to the central venous catheter after dialysis as a lock solution |
| Heparin arm | ACTIVE_COMPARATOR | Heparin: Heparin will be added to the central venous catheter after dialysis as a lock solution |
| Name | Type | Description |
|---|---|---|
| Neutrolin | DRUG | Neutrolin® will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session |
| Heparin | DRUG | Heparin will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session |
Inclusion Criteria: 1. Subject has ESRD and undergoes chronic HD at least two times per week 2. Subject has a HD catheter that has demonstrated the ability to achieve a minimum blood flow of at least 250 mL/min for at least two consecutive dialysis sessions blood flow to enable successful HD 3. The...
Neutrolin is an investigational small molecule being studied for use in chronic kidney failure patients to prevent catheter-related bloodstream infections. It is a catheter lock solution evaluated in a Phase 3 clinical trial in the United States.
Neutrolin is being developed by CorMedix Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol CRMD.
Neutrolin is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 3 trial assessing its safety and effectiveness has been completed.
Neutrolin has been studied in one completed Phase 3 clinical trial, NCT02651428, which enrolled 806 participants with chronic kidney failure and catheter-related infections. The trial was randomized, double-blind, and active-controlled, conducted in the United States.
Neutrolin is a catheter lock solution designed to prevent bloodstream infections in dialysis patients. Its mechanism involves acting as an antimicrobial lock solution, though the specific molecular target has not been disclosed.