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Plasma-Lyte 148 Infusion · 1 trial · 3 indications
Delayed Graft Function defined as receiving treatment with any form of dialysis in the first seven days after transplant
| Arm | Type | Description |
|---|---|---|
| Plasma-Lyte 148 (approx. pH 7.4) IV Infusion | EXPERIMENTAL | Plasma-Lyte 148 (approx. pH 7.4) IV Infusion intravenous fluid therapy will be used for all maintenance, replacement and resuscitation purposes from randomization onwards until 48 hours post-transplant, or until fluid therapy is no longer required, if earlier. |
| 0.9% SODIUM CHLORIDE 9g/L injection BP | ACTIVE_COMPARATOR | 0.9% saline intravenous fluid therapy will be used for all maintenance, replacement and resuscitation purposes from randomization onwards until 48 hours post-transplant, or until fluid therapy is no longer required, if earlier. |
| Name | Type | Description |
|---|---|---|
| Plasma-Lyte 148 (approx. pH 7.4) IV Infusion | DRUG | Plasma-Lyte 148 (approx. pH 7.4) IV Infusion is a sterile, clear, non-pyrogenic isotonic solution and when administered intravenously is a source of water, electrolytes and calories. Plasma-Lyte 148 intravenous infusion is indicated as a source of water \& electrolytes or as an alkalinising agent. |
| 0.9% SODIUM CHLORIDE 9g/L injection BP | DRUG | Sodium chloride (0.9% saline) infusion is a sterile, non-pyrogenic solution of sodium chloride in Water for Injections. The concentration of sodium chloride is 154mmol/L. Sodium chloride (0.9%) intravenous infusion is indicated for extra-cellular fluid replacement and in the management of metabolic alkalosis in the presence of fluid loss, and for restoring or maintaining the concentration of sodium and chloride ions. |
Inclusion Criteria: 1. Adult or child with End-Stage Kidney Disease, of any cause, on maintenance dialysis, or who has pre-dialysis stage 5 chronic kidney disease with an estimated Glomerular Filtration Rate of \<15 mL/min/1.73m2, AND 2. Planned deceased donor kidney transplant from a brain-death (...
Plasma-Lyte 148 Infusion is used for patients with End Stage Kidney Disease, specifically in the context of kidney transplantation. It is an intravenous fluid being studied to help manage complications such as delayed graft function. The drug is currently in Phase 3 clinical development and remains investigational.
Plasma-Lyte 148 Infusion is developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker symbol BAX. Baxter is conducting clinical research to evaluate the fluid's safety and efficacy in patients with End Stage Kidney Disease undergoing kidney transplantation.
Plasma-Lyte 148 Infusion is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the data will inform potential future regulatory submissions for this intravenous fluid.
Plasma-Lyte 148 Infusion has one completed Phase 3 trial, identified as NCT03829488, titled "Better Evidence for Selecting Transplant Fluids." This randomized, double-blind, active-controlled study enrolled 808 participants with End Stage Kidney Disease and kidney transplant complications across Australia and New Zealand.
Plasma-Lyte 148 Infusion is a specific crystalloid solution developed by Baxter. It is not known by any other names in the available data. Its composition is designed to mimic physiological plasma electrolyte levels, but no alternative names have been established for this product.