A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000032448
• Date of registration: 01/05/2018
• Prospective Registration: Yes
• Primary sponsor: Reata Pharmaceuticals, Inc
• Public title: A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome
• Scientific title: A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINAL
• Date of first enrolment: 2018/05/01
• Target sample size: 180
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036991
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not selected

Countries of recruitment

Japan,North America,Australia,Europe

Contacts

• Name: Colin Meyer
• Affiliation: Reata Pharmaceuticals, Inc Product Development

• Name: Yukiko Hagihara
• Affiliation: Labcorp Development Japan K.K. Clinical Development Services

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1. Prior exposure to bardoxolone methyl 2. Ongoing chronic hemodialysis or peritoneal dialysis therapy 3. Renal transplant recipient 4. B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit 5. Uncontrolled diabetes (HbA1c > 11.0%) at Screen A visit 6. Acute dialysis or acute kidney injury within 12 weeks prior to Screen A visit or during Screening 7. Serum albumin < 3 g/dL at Screen A visit 8. History of clinically significant left-sided heart disease and/or clinically significant cardiac disease 9. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 160 mm Hg or sitting diastolic BP > 100 mm Hg at Screen A visit after a period of rest 10. Systolic BP < 90 mm Hg at Screen A visit after a period of rest 11. History of malignancy within 5 years prior to Screen A visit, with the exception of localized skin or cervical carcinomas 12. Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks prior to randomization or anticipated need for immunosuppression during the study 13. Untreated or uncontrolled active bacterial, fungal, or viral infection 14. Participation in other interventional clinical studies within 30 days prior to Day 1 15. Unwilling to practice acceptable methods of birth control (both males who have partners of child-bearing potential and females of childbearing potential) during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested 16. Women who are pregnant or breastfeeding 17. Known hypersensitivity to any component of the study drug

Age minimum: 12years-old
Age maximum: 70years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Alport Syndrome

Intervention(s)

Drug: Bardoxolone Methyl Bardoxolone methyl dose escalated from 5 mg to a maximum of 20 or 30 mg, depending on baseline proteinuria status. Dosing period is up to 2 years.
Drug: Placebo Oral Capsule Capsule containing an inert placebo is administrated up to 2 years.

Primary Outcome(s)

The change from baseline in eGFR in bardoxolone methyl-treated patients relative to placebo at Week 48

Secondary Outcome(s)

The change from baseline in eGFR in bardoxolone methyl-treated patients relative to placebo at Week 52 following a 4-week drug treatment withdrawal period.

Secondary ID(s)

NCT03019185

Source(s) of Monetary Support

Reata Pharmaceuticals, Inc

Ethics review

Status: YES
Approval date: 06/11/2017
Contact:

[e-mail]

Japan Community Health care Organization Sendai Hospital Institutional Review Board

022-275-3111

[e-mail]

Results

• Results available: Yes
• Date Posted: 11/05/2019
• Date Completed: 30/11/2020
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-004395-22/results