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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01712061 | A Phase 2 Multi-Center Study To Evaluate The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist In Adults With Type 2 Diabetes And Overt Nephropathy | PHASE2 | COMPLETED | 226 | — | — | Dec 1, 2012 | Sep 1, 2014 | Oct 21, 2015 | 142 | United States, Argentina +12 |
The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.
| Arm | Type | Description |
|---|---|---|
| Arm 1 PF-04634817 | ACTIVE_COMPARATOR | - |
| Arm 2 Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PF-04634817 | DRUG | Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function |
| Placebo | DRUG | Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function |
Inclusion Criteria: * Clinical diagnosis of type 2 diabetes together with stages 2, 3a, 3b or 4 CKD, based on an eGFR of 20-75 mL/min/1.73m2. * Evidence of persistent, overt albuminuria; defined as a UACR \>=300 mg/g (\>=33.9 mg/mmol) or UPCR \>=390 mg/g (44.1 mg/mmol), or equivalent, for 3 months ...
| 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 |