Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
R3R01 · 2 trials · 3 indications
Urinary albumin-to-creatinine ratio (UACR) (Change from baseline to end of treatment at 12 weeks (84 days).
Safety and tolerability as determined by the incidence of adverse events (AEs)
Change from baseline in urine creatinine protein ratio for Cohort 1 (Alport Syndrome patient group) and Cohort 2(Focal Segmental Glomerulosclerosis patient group).
| Arm | Type | Description |
|---|---|---|
| R3R01 | EXPERIMENTAL | R3R01 oral tablet (200 mg twice daily) for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo oral tablet twice daily for 12 weeks |
| Cohort 2 (Alport Syndrome Patients) | EXPERIMENTAL | R3R01 administered orally as 200 mg tablets twice daily for 84 days. |
| Cohort 3 (Focal Segmental Glomerulosclerosis Patients) | EXPERIMENTAL | R3R01 administered orally as 200 mg tablets twice daily for the 84 days. |
| Name | Type | Description |
|---|---|---|
| R3R01 | DRUG | R3R01 is an ATP-binding cassette transporter A1 (ABCA1) inducer, which increases the efflux of cholesterol from the intracellular space in the kidney. Please refer to arm/group description for further information. |
| Placebo | DRUG | Please refer to arm/group description for further information. |
Inclusion Criteria: 1. Adults (above 18 years of age) with controlled type 2 diabetes (hemoglobin A1c less than 10.5%). 2. Stable antihypertensive treatment 4 weeks before start of study drug and throughout study duration. 3. Titrated to the maximal dose or maximal tolerated dose of renin-angiotens...
R3R01 is an investigational small molecule being studied for Alport Syndrome and Diabetic Kidney Disease. It is in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated for its effect on protein excretion in the urine in patients with these kidney conditions.
R3R01 is being developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker BAX. The drug is currently in Phase 2 clinical trials for kidney-related conditions.
R3R01 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory agencies. Clinical trials are ongoing to evaluate its safety and efficacy in patients with Alport Syndrome and Diabetic Kidney Disease.
R3R01 has been studied in two Phase 2 trials. One trial, NCT05267262, evaluated the drug in patients with Alport Syndrome and Focal Segmental Glomerulosclerosis and has been completed. Another trial, NCT06600412, is currently recruiting patients with Diabetic Kidney Disease in Denmark.
R3R01 is a distinct investigational drug candidate. It is being developed specifically for kidney diseases, including Alport Syndrome and Diabetic Kidney Disease. No alternative names for R3R01 have been reported in clinical trial registries.