Trial · NCT05248646
Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)
NCT05248646, Phase 3, Active not recruiting, Otsuka Pharmaceutical Development & Commercialization, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN). Trials, record NCT05248646. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05248646
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)
- NCT number
- NCT05248646
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 530 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Immunoglobulin A Nephropathy
- Interventions
- Sibeprenlimab 400 mg, Placebo
- First posted
- 2022-02-21
- Last updated
- 2026-07-14
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Urinary protein to creatinine ratio (uPCR) in a 24-hour collection | At 9 months | |
| Secondary | Annualized rate of change (slope) of eGFR | Over 24 months | |
| Secondary | Mean change of eGFR from baseline | Over 24 months | |
| Secondary | Progression to composite kidney failure (CKF) | Time from the randomization date to first occurrence of CKF | |
| Secondary | Percentage of participants with Progression to CKF | Over 24 months | |
| Secondary | Change From Baseline in Total Serum IgA, IgG, and IgM Concentrations | Up to Week 112 | |
| Secondary | Number of Participants With Adverse Events (AEs) | Up to Week 112 | |
| Secondary | Number of Participants With Potentially Clinically Significant Changes in Laboratory Tests | Up to Week 112 | |
| Secondary | Number of Participants With Potentially Clinically Significant Changes in Vital Signs | Up to Week 112 | |
| Secondary | Number of Participants With Potentially Clinically Significant Changes in Physical Examinations | Up to Week 112 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
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/NCT05248646
GET https://conductscience.org/api/trials/v1/NCT05248646/registered