A Phase 2 interventional study of Bardoxolone methyl capsules in IgA Nephropathy, CKD Associated With Type 1 Diabetes and Focal Segmental Glomerulosclerosis, sponsored by Biogen. Completed at 30 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by Biogen · Phase 2, Interventional, and Treatment
Among 72 studies in Glomerulonephritis, IGA with a site in United States — 24 open to participants now, 36 under way, 16 of them phase 3. Glomerulonephritis, IGA · United States.
Among the 72 studies in Glomerulonephritis, IGA with a site in United States, this one is the 25th largest by enrollment of the 67 interventional ones that give a count, is one of 2 that started in 2017, is one of 30 in phase 2, and was the 17th registered.
275 studies on the registry are indexed under Glomerulonephritis, IGA; 107 are open to participants now.
Browse Glomerulonephritis, IGA studies →24 of the 72 studies in Glomerulonephritis, IGA with a site in United States are open now. Recruiting first, the newest first:
Jade Biosciences, Inc. · Sites in United States
argenx · Sites in United States, Japan
Novartis Pharmaceuticals · Sites in United States, China, Colombia and 5 more countries
Akebia Therapeutics · Sites in United States, Brazil
Jade Biosciences, Inc. · Sites in United States, Australia, New Zealand and 2 more countries
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 67 Glomerulonephritis, IGA studies recruiting now, 39 (58%) set no upper age limit and 23 (34%) stop at 75 or younger; 20 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
72 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 33 · Phase 3 22 · Phase 4 7
First in 1997; this study’s year is marked. 2 started in 2017.
This study's enrollment of 103 is above the median of 62 across 221 interventional studies indexed under Glomerulonephritis, IGA.
Median enrollment 67 across the 67 interventional studies, 487 across the 5 observational. Of the 34 that completed or were terminated, 25 (74%) have results posted.
This tab as a report to print or save as PDF → With an account.
57 of 72 have an industry lead sponsor. The 10 most frequent:
Biogen is the lead sponsor of 511 studies on the registry; 24 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 50 (50%) have results posted.
Biogen has 3 studies filed under Glomerulonephritis, IGA — fewer than ten, so there is no comparison to draw.
8 of the studies in Glomerulonephritis, IGA with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06935357Phase 3BiogenA Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN) | 2027-05-31 |
| NCT05852938Phase 3Novartis PharmaceuticalsA Study of Zigakibart in Adults With IgA Nephropathy | 2027-08-10 |
| NCT06712407Calliditas Therapeutics ABEfficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy | 2027-03 |
| NCT06466135Walden BiosciencesStudy of WAL0921 in Patients With Glomerular Kidney Diseases | 2027-03 |
| NCT05003986Travere Therapeutics, Inc.Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases | 2027-03-12 |
Among the 72 studies in Glomerulonephritis, IGA with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Bardoxolone methyl capsules
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.
Drug: Bardoxolone methyl capsules
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.
Drug: Bardoxolone methyl capsules
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.
Drug: Bardoxolone methyl capsules
Bardoxolone 5 mg capsules
Also known as: RTA 402
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.
Time frame: 12 weeks after participant receives the first dose
| Milestone | Bardoxolone Methyl - ADPKD | Bardoxolone Methyl - IgAN | Bardoxolone Methyl - T1D | Bardoxolone Methyl - FSGS |
|---|---|---|---|---|
| Started | 31 | 26 | 28 | 18 |
| Completed | 28 | 26 | 26 | 17 |
| Not completed | 3 | 0 | 2 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 | 1 | 1 |
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.
| mL/min/1.73 m^2 | Bardoxolone Methyl - ADPKD | Bardoxolone Methyl - IgAN | Bardoxolone Methyl - T1D | Bardoxolone Methyl - FSGS |
|---|---|---|---|---|
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 | 9.31 ± 1.3743 | 8.00 ± 1.5700 | 5.46 ± 2.2792 | 7.83 ± 2.216 |
Collected over 16 weeks. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bardoxolone Methyl - ADPKD | 0/31 (0%) | 2/31 (6.5%) | 30/31 (96.8%) |
| Bardoxolone Methyl - IgAN | 0/26 (0%) | 0/26 (0%) | 22/26 (84.6%) |
| Bardoxolone Methyl - T1D | 0/28 (0%) | 0/28 (0%) | 25/28 (89.3%) |
| Bardoxolone Methyl - FSGS | 0/18 (0%) | 1/18 (5.6%) | 16/18 (88.9%) |
| Event | Bardoxolone Methyl - ADPKD | Bardoxolone Methyl - IgAN | Bardoxolone Methyl - T1D | Bardoxolone Methyl - FSGS |
|---|---|---|---|---|
| CholecystitisHepatobiliary disorders | 0/31 | 0/26 | 0/28 | 1/18 |
| Histoplasmosis disseminatedInfections and infestations | 1/31 | 0/26 | 0/28 | 0/18 |
| SepsisInfections and infestations | 1/31 | 0/26 | 0/28 | 0/18 |
| Renal failure acuteRenal and urinary disorders | 1/31 | 0/26 | 0/28 | 0/18 |
| Hypertensive crisisVascular disorders | 1/31 | 0/26 | 0/28 | 0/18 |
| Event | Bardoxolone Methyl - ADPKD | Bardoxolone Methyl - IgAN | Bardoxolone Methyl - T1D | Bardoxolone Methyl - FSGS |
|---|---|---|---|---|
| Muscle spasmsMusculoskeletal and connective tissue disorders | 17/31 | 9/26 | 9/28 | 9/18 |
| HeadacheNervous system disorders | 3/31 | 5/26 | 6/28 | 0/18 |
| FatigueGeneral disorders | 2/31 | 5/26 | 4/28 | 1/18 |
| NauseaGastrointestinal disorders | 3/31 | 1/26 | 5/28 | 0/18 |
| ConstipationGastrointestinal disorders | 0/31 | 1/26 | 1/28 | 3/18 |
| NasopharyngitisInfections and infestations | 2/31 | 1/26 | 0/28 | 3/18 |
| Transaminases increasedInvestigations | 2/31 | 4/26 | 2/28 | 1/18 |
| Upper respiratory tract infectionInfections and infestations | 4/31 | 0/26 | 3/28 | 1/18 |
| HypertensionVascular disorders | 4/31 | 1/26 | 0/28 | 2/18 |
| Hepatic enzyme increasedInvestigations | 2/31 | 3/26 | 3/28 | 2/18 |
All participants who received any amount of study drug
| Age, Continuous(years) | Bardoxolone Methyl - ADPKD | Bardoxolone Methyl - IgAN | Bardoxolone Methyl - T1D | Bardoxolone Methyl - FSGS | Total |
|---|---|---|---|---|---|
| Mean | 47.4 ± 9.49 | 48.5 ± 9.53 | 49 ± 9.91 | 48.6 ± 12.79 | 48.3 ± 10.12 |
| Sex: Female, Male(Participants) | Bardoxolone Methyl - ADPKD | Bardoxolone Methyl - IgAN | Bardoxolone Methyl - T1D | Bardoxolone Methyl - FSGS | Total |
|---|---|---|---|---|---|
| Female | 21 | 11 | 21 | 10 | 63 |
| Male | 10 | 15 | 7 | 8 | 40 |
| Ethnicity (NIH/OMB)(Participants) | Bardoxolone Methyl - ADPKD | Bardoxolone Methyl - IgAN | Bardoxolone Methyl - T1D | Bardoxolone Methyl - FSGS | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 2 | 1 | 8 |
| Not Hispanic or Latino | 28 | 24 | 26 | 17 | 95 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Bardoxolone Methyl - ADPKD | Bardoxolone Methyl - IgAN | Bardoxolone Methyl - T1D | Bardoxolone Methyl - FSGS | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 0 | 1 | 2 |
| Asian | 1 | 4 | 0 | 1 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 0 | 1 | 5 | 10 |
| White | 25 | 22 | 27 | 11 | 85 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Baseline estimated glomerular filtration rate (eGFR)(mL/min/1.73 m^2) | Bardoxolone Methyl - ADPKD | Bardoxolone Methyl - IgAN | Bardoxolone Methyl - T1D | Bardoxolone Methyl - FSGS | Total |
|---|---|---|---|---|---|
| Mean | 47.69 ± 13.630 | 46.19 ± 12.576 | 67.52 ± 17.059 | 51.66 ± 18.144 | 53.39 ± 17.427 |
| Baseline urine albumin-to-creatinine ratio (UACR)(mg/g) | Bardoxolone Methyl - ADPKD | Bardoxolone Methyl - IgAN | Bardoxolone Methyl - T1D | Bardoxolone Methyl - FSGS | Total |
|---|---|---|---|---|---|
| Mean | 44.40 (2.4 to 1824.5) | 104.03 (5.2 to 1288.0) | 30.88 (2.5 to 1208.0) | 184.30 (3.5 to 1006.5) | 63.95 (2.4 to 1824.5) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Data sharing details ↗ · vivli.org
Ran from Dec 2017 to primary completion in Jan 2019, 12 months.
Results were first posted in Jan 2022, 3 years after primary completion. A results delay was requested in Dec 2019.
Of 41 phase 2 interventional studies under Glomerulonephritis, IGA, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 50. This study's 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bardoxolone methyl