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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01447147 | A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy | PHASE2 | COMPLETED | 332 | — | — | Oct 1, 2011 | Dec 1, 2014 | Feb 27, 2025 | 83 | Belgium, Czechia +4 |
| NCT01440257 | A Study to Evaluate the Effect of CCX140-B on Urinary Albumin Excretion in Subjects With Type 2 Diabetes and Albuminuria | PHASE2 | COMPLETED | 20 | — | — | Sep 1, 2011 | Sep 1, 2013 | Feb 27, 2025 | 1 | Netherlands |
The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with diabetic nephropathy.
The primary efficacy objective of this study is to evaluate the effect of CCX140-B treatment on urinary albumin excretion by measuring change from baseline in 24-hour urinary albumin excretion.
| Arm | Type | Description |
|---|---|---|
| Placebo (Group A) | PLACEBO_COMPARATOR | - |
| CCX140-B (Group B) | EXPERIMENTAL | - |
| CCX140-B (Group C) | EXPERIMENTAL | - |
| Active study medication (Group B) | EXPERIMENTAL | CCX140-B |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo capsules once daily |
| CCX140-B | DRUG | CCX140-B capsules once daily (Group B) |
Key Inclusion Criteria: * Aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per American Diabetes Association \[ADA\] criteria) * Residual albuminuria despite stable treatment with an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor b...
| 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 |