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

NCT01500798 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-10-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

20 mg bardoxolone methyl

20 mg, oral, once daily

DRUG

Placebo

Oral, once daily

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Entities

Drugs
Diseases
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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 NCT01500798 on ClinicalTrials.gov