Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00130208 | Effect of Sulodexide in Early Diabetic Nephropathy | PHASE3 | COMPLETED | 1,056 | — | — | Aug 1, 2005 | Feb 1, 2008 | Mar 23, 2018 | 3 | United States, Australia +1 |
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 |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | ALN-ANG3, Evinacumab |
| DexCom, Inc. | DXCM | 1 | PHASE3 | Sotagliflozin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | Atrasentan |
| ProKidney Corp. Class A | PROK | 2 | — | Renal Autologous Cell Therapy |