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NCT03366337 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Focal Segmental Glomerulosclerosis and IgA Nephropathy, sponsored by Biogen.

Completed
Registry status
Phase 2
Development phase
103
Enrollment target
20
Study locations

NCT03366337 is a Phase 2 study of Focal Segmental Glomerulosclerosis and IgA Nephropathy that has completed, run by Biogen. The registered enrollment target is 103 participants, below the 231-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT03366337, a Phase 2 study of Focal Segmental Glomerulosclerosis and IgA Nephropathy, has completed, sponsored by Biogen.

COMPLETED
Registry status
Phase 2
Development phase
103 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Focal Segmental Glomerulosclerosis IgA Nephropathy Autosomal Dominant Polycystic Kidney CKD Associated With Type 1 Diabetes

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

334 total trials

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What the Registry Record Tells You About NCT03366337

The ClinicalTrials.gov registry entry for NCT03366337 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 231-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (55% lower). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

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.

NCT03366337 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Florida, Idaho, Missouri.

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.

What interventions are being tested in trial NCT03366337?

The interventions under investigation include: Bardoxolone methyl capsules (DRUG).

Who is sponsoring clinical trial NCT03366337?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.