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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryChange From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 1212 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.

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 1212 weeks after participant receives the first doseIntent-to-treat population (all enrolled patients)mL/min/1.73 m^2LEAST_SQUARES_MEAN

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12Bardoxolone Methyl - ADPKD9.31Standard Error 1.3743mL/min/1.73 m^2
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12Bardoxolone Methyl - IgAN8.00Standard Error 1.5700mL/min/1.73 m^2
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12Bardoxolone Methyl - T1D5.46Standard Error 2.2792mL/min/1.73 m^2
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12Bardoxolone Methyl - FSGS7.83Standard Error 2.216mL/min/1.73 m^2

Participant flow12

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDBardoxolone Methyl - ADPKD31
Overall StudySTARTEDBardoxolone Methyl - IgAN26
Overall StudySTARTEDBardoxolone Methyl - T1D28
Overall StudySTARTEDBardoxolone Methyl - FSGS18
Overall StudyCOMPLETEDBardoxolone Methyl - ADPKD28
Overall StudyCOMPLETEDBardoxolone Methyl - IgAN26
Overall StudyCOMPLETEDBardoxolone Methyl - T1D26
Overall StudyCOMPLETEDBardoxolone Methyl - FSGS17
Overall StudyNOT COMPLETEDBardoxolone Methyl - ADPKD3
Overall StudyNOT COMPLETEDBardoxolone Methyl - IgAN0

Adverse events676

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAnaemiaBlood and lymphatic system disordersBardoxolone Methyl - ADPKD131
otherAnaemiaBlood and lymphatic system disordersBardoxolone Methyl - IgAN026
otherAnaemiaBlood and lymphatic system disordersBardoxolone Methyl - T1D028
otherAnaemiaBlood and lymphatic system disordersBardoxolone Methyl - FSGS018
otherNephrogenic anaemiaBlood and lymphatic system disordersBardoxolone Methyl - ADPKD031
otherNephrogenic anaemiaBlood and lymphatic system disordersBardoxolone Methyl - IgAN026
otherNephrogenic anaemiaBlood and lymphatic system disordersBardoxolone Methyl - T1D028
otherNephrogenic anaemiaBlood and lymphatic system disordersBardoxolone Methyl - FSGS118
otherNeutropeniaBlood and lymphatic system disordersBardoxolone Methyl - ADPKD031
otherNeutropeniaBlood and lymphatic system disordersBardoxolone Methyl - IgAN026

Adverse event totals12

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityBardoxolone Methyl - ADPKD031
Total, all-cause mortalityBardoxolone Methyl - IgAN026
Total, all-cause mortalityBardoxolone Methyl - T1D028
Total, all-cause mortalityBardoxolone Methyl - FSGS018
Total, other adverse eventsBardoxolone Methyl - ADPKD3031
Total, other adverse eventsBardoxolone Methyl - IgAN2226
Total, other adverse eventsBardoxolone Methyl - T1D2528
Total, other adverse eventsBardoxolone Methyl - FSGS1618
Total, serious adverse eventsBardoxolone Methyl - ADPKD231
Total, serious adverse eventsBardoxolone Methyl - IgAN026

Papers0

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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