Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
bimodal · 1 trial · 1 indication
Ultrafiltration Efficiency (UFE): UFE is defined as the amount of 24 hour net Ultrafiltration (UF) obtained for every gram of carbohydrate absorbed from the dialysis solution. 1. 24-hour net ultrafiltration (in mL) is recorded automatically by the Automated Peritoneal Dialysis (APD) cycler. 2. Carbohydrate absorption is determined by calculating the difference (in grams) between the amount of glucose (measured by lab analysis) in the 24 hr peritoneal effluent, and the amount of glucose in the patient's dialysis prescription. 3. UFE will be calculated in mL/g (ie a divided by b)
| Arm | Type | Description |
|---|---|---|
| bimodal solution | EXPERIMENTAL | 200 mls of 30% glucose in sterile water is added by the patient to the usual icodextrin day dwell, to create the bimodal solution intraperitoneally |
| icodextrin | ACTIVE_COMPARATOR | 200 mls of icodextrin is added by the patient to the usual icodextrin day dwell |
| Name | Type | Description |
|---|---|---|
| bimodal solution | DRUG | 200 mL of 30% glucose infused into the abdomen by the patient each morning for 6 weeks, added to the daytime dwell of approximately 2000 mL icodextrin that has been infused by the cycler |
| icodextrin | DRUG | 200 mL of icodextrin infused into the abdomen by the patient each morning for 6 weeks, added to the daytime dwell of approximately 2000 mL icodextrin that has been infused by the cycler |
Inclusion Criteria: 1. Be able to provide informed consent 2. Age greater than 18 years 3. Be stable Automated Peritoneal Dialysis (APD) patients for at least 6 weeks 4. Be APD patients who; 1. Can be managed with an icodextrin long dwell AND 2. Will use 4.25% and/or a 2.5% solution for at l...
Bimodal is an investigational small molecule being studied for use in End Stage Renal Disease, specifically as a peritoneal dialysis solution. It is being developed by Baxter International Inc. (BAX) and is currently in Phase 2 clinical development.
Bimodal is a small molecule, but its specific molecular target has not been disclosed. It is being studied for its potential use in peritoneal dialysis for patients with End Stage Renal Disease, though the exact mechanism of action is not publicly detailed.
Bimodal is being developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker symbol BAX. The drug is currently in Phase 2 clinical development for End Stage Renal Disease.
Bimodal is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed, with no active trials currently ongoing.
Bimodal has been studied in one completed Phase 2 clinical trial, identified as NCT01242904, titled 'Use of a Bimodal Solution for Peritoneal Dialysis.' This trial enrolled 36 participants with End Stage Renal Disease in Canada and was a randomized, double-blind, active-controlled study.
Bimodal is being studied as a peritoneal dialysis solution for patients with End Stage Renal Disease. The completed Phase 2 trial, NCT01242904, evaluated its use in this setting, comparing it against an active control in a randomized, double-blind design.