Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX

NCT03366337 · View on ClinicalTrials.gov ↗

Study Summary

This multi-center, open-label Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with the following rare chronic kidney diseases (CKD): CKD associated with type 1 diabetes (T1D), IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS), and autosomal dominant polycystic kidney disease (ADPKD). Patients will be enrolled in disease specific cohorts within the trial, and effectiveness of bardoxolone methyl in treating CKD will be assessed separately by cohort for each rare CKD. 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, and 12, and by telephone contact on Days 3, 10, 21, 31, 38, and 45. Patients will also be scheduled to be assessed at an in-person follow-up visit at Week 16, four weeks after the end of treatment.

Interventions

  • DRUG Bardoxolone methyl capsules

Study Locations (20)

Florida

  • Gulfcoast Endocrine and Diabetes Center — Clearwater
  • South Florida Research Institute — Lauderdale Lakes
  • Coastal Nephrology Associates — Port Charlotte

Idaho

  • Boise Kidney & Hypertension, PLLC — Caldwell
  • Boise Kidney & Hypertension, PLLC — Meridian

Missouri

  • Clinical Research Consultants, LLC — Kansas City
  • Washington University School of Medicine — St Louis

New York

  • Columbia University Medical Center - Nephrology — New York
  • Jacobi Medical Center — The Bronx

Alabama

  • University of Alabama Birmingham — Birmingham

Arizona

  • Phoenician Centers for Research & Innovation (PCRI) — Phoenix

California

  • University of California Los Angeles — Los Angeles

Colorado

  • Denver Nephrology — Denver

Trial Details

FieldValue
Enrollment Target 103 participants
Start Date 2017-12-26
Est. Completion 2019-01-29
Phase Phase 2

Sponsor

Biogen

74 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03366337

The ClinicalTrials.gov registry entry for NCT03366337 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 74 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Focal Segmental Glomerulosclerosis appearing as the primary indexed condition, and to 1 intervention — of which Bardoxolone methyl capsules is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03366337 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Florida, Idaho, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03366337 about?

NCT03366337 is a clinical study titled "A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX". This multi-center, open-label Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with the following rare chronic kidney diseases (CKD): CKD associated with type 1 diabetes (T1D), IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS...

What is the current status of trial NCT03366337?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2017-12-26. Estimated completion is 2019-01-29.

What conditions does trial NCT03366337 study?

This clinical trial studies the following conditions: Focal Segmental Glomerulosclerosis, IgA Nephropathy, Autosomal Dominant Polycystic Kidney, CKD Associated With Type 1 Diabetes. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03366337?

The interventions under investigation include: Bardoxolone methyl capsules (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03366337?

This trial is sponsored by Biogen, which has 74 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03366337 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial