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Trial record 6 of 7879 for:    "Kidney Diseases"

A Phase 3 Study of Bardoxolone Methyl in Patients With Diabetic Kidney Disease; AYAME Study

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ClinicalTrials.gov Identifier: NCT03550443
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd

Brief Summary:
The purpose of this study is to demonstrate the efficacy of multiple oral doses of RTA 402 (5, 10, or 15 mg) administered once daily in patients with diabetic kidney disease (DKD) using the time to onset of a ≥ 30% decrease in estimated glomerular filtration rate calculated from serum creatinine (eGFR) from baseline or end-stage renal disease (ESRD) as an indicator in a randomized, double-blind, placebo-controlled study; the safety of RTA 402 will also be evaluated.

Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease Drug: Bardoxolone methyl Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: RTA 402 Phase 3 Clinical Trial (A Randomized, Double-blind, Placebo-controlled Clinical Trial in Patients With Diabetic Kidney Disease)
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RTA 402(Bardoxolone methyl)
Patients will receive multiple oral doses of bardoxolone methyl once daily. The starting dose of bardoxolone methyl will be 5 mg. The maximum dose will be 15 mg, and the dose will be increased by 5 mg.
Drug: Bardoxolone methyl
Bardoxolone methyl 5 mg capsules
Other Name: RTA 402

Placebo Comparator: Placebo
Patients randomized to placebo will remain on placebo throughout the study, undergoing sham titration.
Drug: Placebo
Capsules containing an inert placebo




Primary Outcome Measures :
  1. Time to onset of a ≥ 30% decrease in eGFR from baseline or ESRD [ Time Frame: Through study completion, approximately 2 to 3 years ]

Secondary Outcome Measures :
  1. Time to onset of a ≥ 40% decrease in eGFR from baseline or ESRD [ Time Frame: Through study completion, approximately 2 to 3 years ]
  2. Time to onset of a ≥ 53% decrease in eGFR from baseline or ESRD [ Time Frame: Through study completion, approximately 2 to 3 years ]
  3. Time to onset of ESRD [ Time Frame: Through study completion, approximately 2 to 3 years ]
  4. Change in eGFR from baseline at each evaluation time point [ Time Frame: Through study completion, approximately 2 to 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with DKD
  • Mean eGFR ≥ 15 and < 60 mL/min/1.73 m²
  • Albumin/creatinine ratio (ACR) ≤ 3500 mg/g Cr
  • Treatment with an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) with no change in dosage or medication etc.

Exclusion Criteria:

  • Diabetes mellitus that is neither type 1 nor type 2
  • Decreased renal function mainly attributed to a non-diabetic cause
  • History of renal transplantation or upcoming preemptive renal transplantation
  • Confirmed mean systolic blood pressure > 160 mmHg or a confirmed mean diastolic blood pressure > 90 mmHg during the 8-week period before screening
  • Hemoglobin A1c level > 10.0% during screening
  • Serum albumin level ≤ 3.0 g/dL during screening
  • Cardiovascular disease specified in the study protocol
  • History of cardiac failure
  • BNP level > 200 pg/mL during screening etc.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550443


Contacts
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Contact: Kyowa Hakko Kirin Co., Ltd. 090-5561-3180 clinical.info@kyowa-kirin.co.jp

Locations
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Japan
Japan Community Health care Organization Sendai Hospital Recruiting
Sendai, Miyagi, Japan, 981-0912
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd

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Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT03550443     History of Changes
Other Study ID Numbers: RTA 402-006
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Kyowa Hakko Kirin Co., Ltd:
Bardoxolone Methyl
Diabetic Kidney Disease
Diabetes Mellitus
Kidney Diseases

Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases