| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03804879 | Safety, Tolerability and Efficacy of Nidufexor in Patients With Diabetic Nephropathy | PHASE2 | COMPLETED | 83 | — | — | Dec 17, 2018 | May 3, 2021 | Aug 10, 2022 | 18 | United States, Argentina +5 |
UACR is a ratio between albumin and creatinine, and it estimates 24-hour urine albumin excretion. UACR (mg/mmol) = urine albumin \[mg/L\] / urine creatinine \[mmol/L\]. UACR was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement.
Albuminuria describes the existence of albumin in the urine and the gold-standard to assess albuminuria is 24-hour urinary albumin excretion (milligram/24 hours). An analysis of covariance (ANCOVA) with treatment as the classification factor and log-transformed baseline as the covariate was conducted for log-transformed ratio to baseline 24-hour urinary albumin excretion. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement.
Number of participants with AEs and SAEs including significant changes from baseline in vital signs, electrocardiograms and laboratory values qualifying and reported as AEs. The category Number of participants with AEs includes also the number of participants with SAEs. The number of participants in each category is reported in the table.
| Arm | Type | Description |
|---|---|---|
| LMB763 | EXPERIMENTAL | 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC. |
| Placebo | PLACEBO_COMPARATOR | Placebo was orally administered once daily for 24 weeks in addition to SoC. |
| Name | Type | Description |
|---|---|---|
| Nidufexor | DRUG | 50 mg (two 25 mg) LMB763 capsules for oral administration |
| Placebo | OTHER | Placebo capsules for oral administration |
| Standard of Care (SoC) | DRUG | Optimal tolerated doses of angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) |
Inclusion Criteria: * Male/female patients, 18-75 years * Written informed consent * Diagnosis of Type 2 diabetes mellitus, with diagnosis made at least 6 months prior to screening * Diabetic nephropathy as evidenced by Urine albumin-Cr ratio (UACR) ≥300 mg/g Cr at screening while receiving a dose ...
| 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 |