drugset / Trial / NCT01500798

A Pharmacodynamic Study of Measured Glomerular Filtration Rate in Patients With Chronic Kidney Disease and Type 2 Diabetes

NCT01500798 ↗

Phase 1 Terminated 18 enrolled Biogen
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a 24-week multi-center, double-blind, randomized, exploratory study of bardoxolone methyl treatment in 18 patients with Stage 3 CKD (eGFR greater than or equal to 30.0 to less than 60.0 ml/min/1.73m2) and diabetes to ensure at least 15 patients complete the study for evaluation of the primary endpoints.

Timeline

Start
2012-01-31
Primary completion
2012-11-01
Completion
2013-10-01

Outcome

Outcome not reported

Stopped: “IDMC recommendation for safety concerns”

Drugs

EvaluationDrugModalityDoseRoute
Subject Bardoxolone methyl Small molecule 20 mg Oral