IgA NephropathyPhase 2PHOENIXNCT03366337
A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX
A Phase 2 study testing Bardoxolone methyl capsules in people with IgA Nephropathy and CKD Associated With Type 1 Diabetes, run by Biogen at 30 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IgA Nephropathy, CKD Associated With Type 1 Diabetes, Focal Segmental Glomerulosclerosis
- What is being tested?
- Bardoxolone methyl capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 30 sitesUnited States
- Study dates
- 26 Dec 2017to 29 Jan 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients 18 ≤ age ≤ 65 upon study consent;
- Screening eGFR (average of Screen A and Screen B eGFR values) ≥ 30 and ≤ 90 mL/min/1.73 m2. 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;
- If receiving an angiotensin-converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB), patients should be prescribed the maximally tolerated labeled daily dose (MTLDD) for at least 6 weeks prior to the Screen A visit;
- For patients enrolling in T1D Cohort: Diagnosis of type 1 diabetes confirmed by fasting C-peptide level. Diagnosis must have been made ≤ 35 years of age; and prescribed stable dose of insulin to maintain adequate glucose control for at least 6 months prior to the Screen A visit;
- For patients enrolling in IgAN Cohort: Biopsy-confirmed IgA nephropathy;
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- For patients enrolling in FSGS Cohort: Biopsy-confirmed FSGS that is not due to known secondary causes including morbid obesity, decreased renal mass, viral infections, drug-induced nephrotoxicity, or prior history of vasculitis;
- For patients enrolling in ADPKD Cohort: Genetic confirmation of PKD1 mutation;
- Adequate bone marrow reserve and organ function at the Screen A visit as follows: Hematologic: Absolute neutrophil count > 1.5 x 109/L, platelets > 100 x 109/L, hemoglobin (Hgb) ≥ 9 g/dL; and Hepatic: Total bilirubin (TBL) ≤ 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times ULN.
Who cannot join
- Kidney or any other solid organ transplant recipient or a planned transplant during the study;
- B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit;
- Acute dialysis or acute kidney injury within 12 weeks prior to Screen A visit or during Screening;
- Serum albumin < 3 g/dL at Screen A visit;
- Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks prior to randomization or anticipated need for immunosuppression during the study;
- For patients enrolling in IgAN Cohort: Systemic manifestations of Henoch-Schonlein purpura within 1 year prior to Screen A visit; or have used belimumab, eculizumab, or rituximab within 6 months prior to Screen A visit;
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- For patients enrolling in ADPKD Cohort: Receiving tolvaptan;
- Cerebrovascular event (stroke, transient ischemic attack) or aneurysm within 6 months prior to Screen A visit or during Screening;
- History of clinically significant left-sided heart disease and/or clinically significant cardiac disease;
- Uncontrolled systemic hypertension;
- Systolic BP < 90 mm Hg at Screen A visit after a period of rest;
- History of malignancy within 2 years prior to Screen A visit, with the exception of localized skin or cervical carcinomas;
- Uncontrolled diabetes (HbA1c > 10.0%) at Screen A visit;
- Untreated or uncontrolled active bacterial, fungal, or viral infection;
- Participation in other interventional clinical studies within 30 days prior to Day 1;
- 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;
- Women who are pregnant or breastfeeding.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Kidney Care Augusta
Augusta, Georgia, 30909
Research Management, Inc.
Austin, Texas, 78751
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, 18017
University of Alabama Birmingham
Birmingham, Alabama, 35294
Tufts Medical Center - Division of Nephrology Tufts Medical Center
Boston, Massachusetts, 02110
Boise Kidney & Hypertension, PLLC
Caldwell, Idaho, 83605
Nephrology Associates
Chattanooga, Tennessee, 37404
Gulfcoast Endocrine and Diabetes Center
Clearwater, Florida, 33756
Remington-Davis Clinical Research
Columbus, Ohio, 43215
Renal Disease Research Intitute
Dallas, Texas, 75235
Denver Nephrology
Denver, Colorado, 80230
Research By Design
Evergreen Park, Illinois, 60805
Mendez Center for Clinical Research LLC
Fairfax Station, Virginia, 22039
Larry Stonesifer, M.D.
Federal Way, Washington, 98003
Physician's East Endocrine Research
Greenville, North Carolina, 27834
University of Kansas Medical Center
Kansas City, Kansas, 66160
Clinical Research Consultants, LLC
Kansas City, Missouri, 64111
South Florida Research Institute
Lauderdale Lakes, Florida, 33313
University of California Los Angeles
Los Angeles, California, 90095
Boise Kidney & Hypertension, PLLC
Meridian, Idaho, 83642
Columbia University Medical Center - Nephrology
New York, New York, 10032
Four Rivers Clinical Research, Inc
Paducah, Kentucky, 42003
Phoenician Centers for Research & Innovation (PCRI)
Phoenix, Arizona, 85021
Coastal Nephrology Associates
Port Charlotte, Florida, 33952
The Warren Alpert School of Brown University
Providence, Rhode Island, 02903
Renal Associates, PA
San Antonio, Texas, 78215
Northwest Louisiana Nephrology
Shreveport, Louisiana, 71101
Washington University School of Medicine
St Louis, Missouri, 63110
Jacobi Medical Center
The Bronx, New York, 10461
Advanced Clinical Research
West Jordan, Utah, 84088
About this study
Official title: A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases
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
- IgA Nephropathy, CKD Associated With Type 1 Diabetes, Focal Segmental Glomerulosclerosis, Autosomal Dominant Polycystic Kidney
- Being tested
- Bardoxolone methyl capsules
- Keywords
- IgA Nephropathy, CKD associated with type 1 diabetes, Focal segmental glomerulosclerosis, Autosomal dominant polycystic kidney disease, IgAN, FSGS, ADPKD, Bardoxolone methyl, CDDO-ME, RTA 402
- Medical subject headings
- Glomerulonephritis, IGA, Glomerulosclerosis, Focal Segmental, Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bardoxolone methyl capsulesDrug
Also called RTA 402
Bardoxolone 5 mg capsules
| Study group | Role | What they receive |
|---|---|---|
| Bardoxolone Methyl - ADPKD | Experimental | Participants with autosomal polycystic kidney disease (ADPKD) will receive bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily. Receives: Drug: Bardoxolone methyl capsules |
| Bardoxolone Methyl - IgAN | Experimental | Participants with IgA nephropathy (IgAN) will receive bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily. Receives: Drug: Bardoxolone methyl capsules |
| Bardoxolone Methyl - T1D | Experimental | Participants with Type 1 diabetes (T1D) will receive bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily. Receives: Drug: Bardoxolone methyl capsules |
| Bardoxolone Methyl - FSGS | Experimental | Participants with focal segmental glomerulosclerosis (FSGS) will receive bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily. Receives: Drug: Bardoxolone methyl capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12
To assess the change in eGFR from baseline to week 12. eGFR is a measure of kidney function assessed through blood/serum. Higher eGFRs represent better/improved kidney function. Lower eGFRs represent poorer/decreased kidney function.
Measured: 12 weeks after participant receives the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start26 Dec 2017
- Primary completion2 Jan 2019
- Study completion29 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366337
- Sponsor's protocol ID
- 402-C-1702
- Acronym
- PHOENIX
- Status last verified
- May 2025
- First submitted
- 4 Dec 2017
- Last updated
- 3 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases
- ClinicalTrials.gov ID
- NCT03366337
- Acronym / sponsor ID
- PHOENIX / 402-C-1702
- Conditions
- IgA Nephropathy, CKD Associated With Type 1 Diabetes, Focal Segmental Glomerulosclerosis, Autosomal Dominant Polycystic Kidney
- Keywords
- IgA Nephropathy, CKD associated with type 1 diabetes, Focal segmental glomerulosclerosis, Autosomal dominant polycystic kidney disease, IgAN, FSGS, ADPKD, Bardoxolone methyl
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2017 (actual)
- Primary completion
- 2 Jan 2019 (actual)
- Study completion
- 29 Jan 2019 (actual)
- First posted
- 8 Dec 2017 (actual)
- Results
- Posted 18 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bardoxolone Methyl - ADPKD | Experimental | Drug: Bardoxolone methyl capsulesParticipants with autosomal polycystic kidney disease (ADPKD) will receive bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily. |
| Bardoxolone Methyl - IgAN | Experimental | Drug: Bardoxolone methyl capsulesParticipants with IgA nephropathy (IgAN) will receive bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily. |
| Bardoxolone Methyl - T1D | Experimental | Drug: Bardoxolone methyl capsulesParticipants with Type 1 diabetes (T1D) will receive bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily. |
| Bardoxolone Methyl - FSGS | Experimental | Drug: Bardoxolone methyl capsulesParticipants with focal segmental glomerulosclerosis (FSGS) will receive bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female patients 18 ≤ age ≤ 65 upon study consent;
- Screening eGFR (average of Screen A and Screen B eGFR values) ≥ 30 and ≤ 90 mL/min/1.73 m2. 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;
- If receiving an angiotensin-converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB), patients should be prescribed the maximally tolerated labeled daily dose (MTLDD) for at least 6 weeks prior to the Screen A visit;
- For patients enrolling in T1D Cohort: Diagnosis of type 1 diabetes confirmed by fasting C-peptide level. Diagnosis must have been made ≤ 35 years of age; and prescribed stable dose of insulin to maintain adequate glucose control for at least 6 months prior to the Screen A visit;
Key exclusion criteria (17 listed)
- Kidney or any other solid organ transplant recipient or a planned transplant during the study;
- B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit;
- Acute dialysis or acute kidney injury within 12 weeks prior to Screen A visit or during Screening;
- Serum albumin < 3 g/dL at Screen A visit;
- Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks prior to randomization or anticipated need for immunosuppression during the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bardoxolone methyl capsulesAlso: RTA 402Bardoxolone 5 mg capsules | Drug | Bardoxolone Methyl - ADPKD, Bardoxolone Methyl - FSGS, Bardoxolone Methyl - IgAN, Bardoxolone Methyl - T1D |
Primary outcome
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12
Time frame: 12 weeks after participant receives the first dose
To assess the change in eGFR from baseline to week 12. eGFR is a measure of kidney function assessed through blood/serum. Higher eGFRs represent better/improved kidney function. Lower eGFRs represent poorer/decreased kidney function.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Link to the PHOENIX trial website, which contains information about the trial and participating centersLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bardoxolone methyl capsules in people with IgA Nephropathy and CKD Associated With Type 1 Diabetes, run by Biogen at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 (time frame: 12 weeks after participant receives the first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.