NCT02316821

Brief Summary

The purpose of this study is to assess the safety and efficacy of RTA 402 in chronic kidney disease (CKD) patients with type 2 diabetes in a double-blind, placebo-controlled study when this compound is administered once daily for 16 weeks in an intrapatient dose escalation design.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 15, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

1.4 years

First QC Date

November 27, 2014

Last Update Submit

October 26, 2017

Conditions

Chronic Kidney DiseaseType 2 Diabetes

Keywords

Diabetes MellitusDiabetes Mellitus, Type 2Diabetic NephropathiesKidney DiseasesRenal Insufficiency, ChronicDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesRenal InsufficiencyUrologic Diseasesbardoxolone methyl

Outcome Measures

Primary Outcomes (2)

  • Safety: Number and types of adverse events

    Count of adverse events, by type, in the bardoxolone methyl arm compared to the placebo arm

    Up to 16 weeks

  • Change in glomerular filtration rate (GFR) measured by inulin clearance after 16 weeks of study drug administration, compared to baseline GFR

    Change in GFR from baseline to 16 weeks

    Up to 16 weeks

Secondary Outcomes (2)

  • Change in estimated GFR (eGFR) after 16 weeks of study drug administration, compared to baseline eGFR

    Up to 16 weeks

  • Profiles of pharmacokinetics of plasma RTA 402 concentration: Trough (Pre-dose) and peak (2-4 hours post dose) concentrations of study drug at steady state

    Baseline, week 2, 6, 10, and 4 weeks after completion of study treatment

Study Arms (2)

bardoxolone methyl

EXPERIMENTAL

bardoxolone methyl capsules, dosage To Be Determined, once daily for 16 weeks

Drug: RTA 402

Placebo

PLACEBO COMPARATOR

Placebo capsules, once daily for 16 weeks

Drug: Placebo

Interventions

RTA 402DRUG
bardoxolone methyl
PlaceboDRUG
Placebo

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CKD patients with type 2 diabetes mellitus
  • Patients whose estimated GFR levels are eligible for this study
  • Patients being treated with stable dose of angiotensin converting enzyme (ACE) inhibitors and/or angiotensin II receptor blocker (ARB) etc.

You may not qualify if:

  • Patients with type 1 diabetes mellitus
  • Patients with known non-diabetic renal disease
  • Patients with a history of renal transplantation
  • Patients with mean systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 90 mmHg
  • Patients with Hemoglobin A1c \> 10%
  • Patients with cardiovascular disease specified in the study protocol etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

Related Publications (3)

  • Yoshioka K, Kaneko H, Haruyama W, Tomiyama T, Takami A, Kitayama T, Yamasaki K. Multi-Omics Reveal Antioxidant Effects of Bardoxolone Methyl in the Phase 2 Study of Bardoxolone Methyl in Patients with CKD and Type 2 Diabetes Study. Kidney360. 2025 Nov 1;6(11):1880-1889. doi: 10.34067/KID.0000000853. Epub 2025 Jun 11.

    PMID: 40498549DERIVED

  • Mwesigwa N, Millar Vernetti P, Kirabo A, Black B, Ding T, Martinez J, Palma JA, Biaggioni I, Kaufmann H, Shibao CA. Atomoxetine on neurogenic orthostatic hypotension: a randomized, double-blind, placebo-controlled crossover trial. Clin Auton Res. 2024 Dec;34(6):561-569. doi: 10.1007/s10286-024-01051-2. Epub 2024 Sep 19.

    PMID: 39294522DERIVED

  • Ikejiri K, Suzuki T, Muto S, Takama H, Yamawaki K, Miyazawa T, Urakawa I, Aoki Y, Otsuki A, Katsuoka F, Kinoshita K, Nangaku M, Akizawa T, Yamamoto M. Effects of NRF2 polymorphisms on safety and efficacy of bardoxolone methyl: subanalysis of TSUBAKI study. Clin Exp Nephrol. 2024 Mar;28(3):225-234. doi: 10.1007/s10157-023-02427-w. Epub 2023 Nov 14.

    PMID: 37962746DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicDiabetes Mellitus, Type 2Diabetes MellitusDiabetic NephropathiesKidney DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesRenal InsufficiencyUrologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2014

First Posted

December 15, 2014

Study Start

December 1, 2014

Primary Completion

May 1, 2016

Study Completion

September 1, 2017

Last Updated

October 27, 2017

Record last verified: 2017-10

Locations

JP(1)