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A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Effects of Bardoxolone Methyl on Body Composition in Patients With Stage 4 Chronic Kidney Disease and Type 2 Diabetes Mellitus

NCT01655186 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-05-29

No results posted yet for this study

Summary

This multicenter, randomized, double-blind, placebo-controlled Phase 2 safety study will assess the effect of bardoxolone methyl relative to placebo on body weight and fat mass in approximately 60 patients with stage 4 Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM).

Conditions

  • Renal Insufficiency, Chronic
  • Diabetes Mellitus, Type 2

Interventions

DRUG

Bardoxolone Methyl

DRUG

Placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2012-10-31
Completion
2012-10-31

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01655186 on ClinicalTrials.gov