The Phase II Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes; TSUBAKI Study

Type 2 Diabetes Clinical Trial

Official title:

RTA 402 Phase 2 Clinical Trial (A Randomized, Double-blind, Placebo-controlled Clinical Trial in Patients With Chronic Kidney Disease and Type 2 Diabetes)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02316821
• Other study ID #: RTA 402-005
• Status: Completed
• Phase: Phase 2
• First received: November 27, 2014
• Last updated: October 26, 2017
• Start date: December 2014
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: Kyowa Hakko Kirin Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: September 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes

Intervention

Drug:
• RTA 402

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in estimated GFR (eGFR) after 16 weeks of study drug administration, compared to baseline eGFR	Change in eGFR from baseline to 16 weeks	Up to 16 weeks
Secondary	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	Relationship between the study drug dose and the 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