Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| DexCom, Inc. | DXCM | 1 | PHASE3 | Sotagliflozin |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | ALN-ANG3, Evinacumab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | Atrasentan |
| ProKidney Corp. Class A | PROK | 2 | - | Renal Autologous Cell Therapy |
Sulodexide is an investigational small molecule being studied for the treatment of diabetic nephropathy, a kidney condition that can occur in people with diabetes. It is currently in Phase 3 clinical development and has not been approved by the FDA.
Sulodexide is being developed by Akebia Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AKBA. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with diabetic nephropathy.
Sulodexide is in Phase 3 clinical development for diabetic nephropathy. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug remains under investigation.
Sulodexide was studied in a Phase 3 clinical trial with the identifier NCT00130208, titled "Effect of Sulodexide in Early Diabetic Nephropathy." The trial enrolled 1,056 participants and was completed. It was a randomized, double-blind, placebo-controlled study conducted in the United States, Australia, and the Netherlands.
Sulodexide is the primary name for this investigational drug. No alternative names have been reported for this asset in clinical development.