Trial · NCT03366337
A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX
NCT03366337, Phase 2, Completed, Biogen; results first posted 2022-01-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX. Trials, record NCT03366337. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03366337
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX
- NCT number
- NCT03366337
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 103 participants, actual
- Lead sponsor
- Biogen
- Conditions
- IgA Nephropathy, CKD Associated With Type 1 Diabetes, Focal Segmental Glomerulosclerosis, Autosomal Dominant Polycystic Kidney
- Interventions
- Bardoxolone methyl capsules
- First posted
- 2017-12-08
- Last updated
- 2025-06-03
- Results first posted
- 2022-01-18
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 | 12 weeks after participant receives the first dose | Intent-to-treat population (all enrolled patients) | mL/min/1.73 m^2 | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 | Bardoxolone Methyl - ADPKD | 9.31 | Standard Error 1.3743 | mL/min/1.73 m^2 | |
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 | Bardoxolone Methyl - IgAN | 8.00 | Standard Error 1.5700 | mL/min/1.73 m^2 | |
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 | Bardoxolone Methyl - T1D | 5.46 | Standard Error 2.2792 | mL/min/1.73 m^2 | |
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 | Bardoxolone Methyl - FSGS | 7.83 | Standard Error 2.216 | mL/min/1.73 m^2 |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bardoxolone Methyl - ADPKD | 31 | |
| Overall Study | STARTED | Bardoxolone Methyl - IgAN | 26 | |
| Overall Study | STARTED | Bardoxolone Methyl - T1D | 28 | |
| Overall Study | STARTED | Bardoxolone Methyl - FSGS | 18 | |
| Overall Study | COMPLETED | Bardoxolone Methyl - ADPKD | 28 | |
| Overall Study | COMPLETED | Bardoxolone Methyl - IgAN | 26 | |
| Overall Study | COMPLETED | Bardoxolone Methyl - T1D | 26 | |
| Overall Study | COMPLETED | Bardoxolone Methyl - FSGS | 17 | |
| Overall Study | NOT COMPLETED | Bardoxolone Methyl - ADPKD | 3 | |
| Overall Study | NOT COMPLETED | Bardoxolone Methyl - IgAN | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events676
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Bardoxolone Methyl - ADPKD | 1 | 31 | |
| other | Anaemia | Blood and lymphatic system disorders | Bardoxolone Methyl - IgAN | 0 | 26 | |
| other | Anaemia | Blood and lymphatic system disorders | Bardoxolone Methyl - T1D | 0 | 28 | |
| other | Anaemia | Blood and lymphatic system disorders | Bardoxolone Methyl - FSGS | 0 | 18 | |
| other | Nephrogenic anaemia | Blood and lymphatic system disorders | Bardoxolone Methyl - ADPKD | 0 | 31 | |
| other | Nephrogenic anaemia | Blood and lymphatic system disorders | Bardoxolone Methyl - IgAN | 0 | 26 | |
| other | Nephrogenic anaemia | Blood and lymphatic system disorders | Bardoxolone Methyl - T1D | 0 | 28 | |
| other | Nephrogenic anaemia | Blood and lymphatic system disorders | Bardoxolone Methyl - FSGS | 1 | 18 | |
| other | Neutropenia | Blood and lymphatic system disorders | Bardoxolone Methyl - ADPKD | 0 | 31 | |
| other | Neutropenia | Blood and lymphatic system disorders | Bardoxolone Methyl - IgAN | 0 | 26 |
1 to 10 of 676Source ClinicalTrials.gov
See all 676 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bardoxolone Methyl - ADPKD | 0 | 31 |
| Total, all-cause mortality | Bardoxolone Methyl - IgAN | 0 | 26 |
| Total, all-cause mortality | Bardoxolone Methyl - T1D | 0 | 28 |
| Total, all-cause mortality | Bardoxolone Methyl - FSGS | 0 | 18 |
| Total, other adverse events | Bardoxolone Methyl - ADPKD | 30 | 31 |
| Total, other adverse events | Bardoxolone Methyl - IgAN | 22 | 26 |
| Total, other adverse events | Bardoxolone Methyl - T1D | 25 | 28 |
| Total, other adverse events | Bardoxolone Methyl - FSGS | 16 | 18 |
| Total, serious adverse events | Bardoxolone Methyl - ADPKD | 2 | 31 |
| Total, serious adverse events | Bardoxolone Methyl - IgAN | 0 | 26 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03366337
GET https://conductscience.org/api/trials/v1/NCT03366337/events?page=2