Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as KRX-101
Sulodexide · 1 trial · 1 indication
The primary efficacy variable was the fraction of those patients in the ITT population with valid baseline and Week 26 ACRs in whom "therapeutic success" was achieved at Week 26 measured as a conversion of microalbuminuria to normoalbuminuria and at least a 25% reduction in ACR relative to baseline
During the treatment period, KRX-101 is being compared to placebo to assess whether a 50% reduction in microalbuminuria has been achieved.
| Arm | Type | Description |
|---|---|---|
| Sulodexide | EXPERIMENTAL | Also known as KRX-101. All patients will be on standard of care ACE or ARBs. |
| Placebo | PLACEBO_COMPARATOR | All patients will be on standard of care ACE or ARBs. |
| Name | Type | Description |
|---|---|---|
| Sulodexide | DRUG | 100 mg sulodexide gelcaps |
| Placebo | DRUG | 0 mg gelcap |
Inclusion Criteria: * Diagnosis of type 2 diabetes * Serum creatinine equal to or less than 1.5 mg/dL * Microalbuminuria, defined by a urine albumin/creatinine ratio in men; 35- 200 mg albumin/G creatinine, in women; 45-200 mg albumin/G creatinine * Blood pressure controlled to less than 150/90 mmH...
Top 3 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | ALN-ANG3, Evinacumab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | Atrasentan |
| ProKidney Corp. Class A | PROK | 2 | - | Rilparencel |
Sulodexide is being developed for diabetic nephropathy, a kidney complication of diabetes. Akebia Therapeutics is studying it in a Phase 3 program. It is an investigational therapy and has not been approved for this indication.
Sulodexide is being developed by Akebia Therapeutics, Inc., which trades on the Nasdaq under the ticker AKBA. The company is advancing the drug for diabetic nephropathy.
Sulodexide is in Phase 3 development for diabetic nephropathy. The program includes one completed Phase 3 trial. It remains investigational and is not approved for marketing in this indication.
Sulodexide has been studied in the Phase 3 trial NCT00130208, titled Effect of Sulodexide in Early Diabetic Nephropathy. The trial enrolled 1,056 participants across the United States, Australia, and the Netherlands and is now completed.
The Phase 3 trial NCT00130208 was a randomized, double-blind, placebo-controlled study in adults 18 years and older with early diabetic nephropathy. It enrolled 1,056 participants and has been completed.