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Completed

NCT Number: NCT02316821

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

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Nephropathies Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Type 2 Diabetes Urogenital Diseases Urologic Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RTA 402

Drug

Placebo

Drug

Primary outcomes

  1. Safety: Number and types of adverse events

    Time frame: Up to 16 weeks

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

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

    Time frame: Up to 16 weeks

    Change in GFR from baseline to 16 weeks

Secondary outcomes

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

    Time frame: Up to 16 weeks

    Change in eGFR from baseline to 16 weeks

  2. 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

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

    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

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Dec 15, 2014
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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