Clinical Research

Bardoxolone Methyl in Subjects With ADPKD

Sponsored by: Reata Pharmaceuticals, Inc.

This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD.

Patients will be randomized 1:1 to either bardoxolone methyl or placebo. Patients receiving bardoxolone methyl will start with once-daily dosing at 5 mg and will dose-escalate to 10 mg at Week 2, to 20 mg at Week 4, and then to 30 mg at Week 6 (only if baseline ACR >300 mg/g) unless contraindicated clinically and approved by the medical monitor. Dose de-escalation is permitted during the study if indicated clinically, and subsequent dose re-escalation is also permitted to meet the dosing objective of the highest tolerated dose.

All patients in the study will follow the same visit and assessment schedule. Following randomization on Day 1, patients will be scheduled to be assessed during treatment at Weeks 1, 2, 4, 6, 8, 12, 24, 36, 48, 52, 64, 76, 88, 100, and 104 and by telephone contact on Days 3, 10, 21, 31, 38, and 45. Patients will not receive study drug during a 4-week withdrawal period between Weeks 48 and 52. They will re-start treatment at Week 52 at the same dose they received at Week 48 and will continue study drug treatment through Week 100. Patients will also be scheduled to be assessed at an in-person follow-up visit at Week 104, four weeks after the end of treatment.

Who can participate?

You may be able to join the study if you have:

  • Male and female patients 18 ≤ age ≤ 70 upon study consent
  • Diagnosis of ADPKD by modified Pei-Ravine criteria: 1) at least 3 cysts per kidney by sonography or at least 5 cysts by CT or MRI with family history of ADPKD or 2) at least 10 cysts per kidney by any radiologic method and exclusion of other cystic kidney diseases if without family history
  • Screening eGFR (average of Screen A and Screen B eGFR values) ≥ 30 to≤ 90 mL/min/1.73 m2 (18 to 55 years) or ≥ 30 to ≤ 44 mL/min/1.73 m2 (56 to 70 years)
  • 1) Patients with either screening eGFR ≥ 60 to ≤ 90 mL/min/1.73 m2 or age 56 to 70 years, must have evidence of ADPKD progression (i.e., eGFR decline of ≥ 2.0 mL/min/1.73 m2 per year, based on historical eGFR data and medical monitor discretion)

     2)The two eGFR values collected at Screen A and Screen B visits used to determine eligibility must have a percent difference ≤ 25%

  • Albumin to creatinine ratio (ACR) ≤ 2500 mg/g at Screen B visit
  • Systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 80 mmHg at Screen A visit after a period of rest. Patients receiving an angiotensin-converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) must be on a stable dose for at least 6 weeks prior to the Screen A visit.

What will happen during the study?

If you are eligible and agree to participate in the study, you will be required to:

  • Visit the study clinic up to 18 times
  • Have Kidney Ultrasound, Echocardiogram, and ECG procedures
  • Take the investigational medication daily as directed by the study doctor
  • Have blood and urine tests
  • Drink enough fluids (a minimum of 8 to 12 glasses during the day)
  • Enrollment is closing soon.

For more information: visit https://clinicaltrials.ucsf.edu/trial/NCT03918447 and https://clinicaltrials.gov/ct2/show/NCT03918447

You may also contact [email protected] or 415-502-3618.