Trial · NCT04883619
A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis
NCT04883619, Phase 2, Withdrawn, Janssen Research & Development, LLC
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis. Trials, record NCT04883619. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04883619
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis
- NCT number
- NCT04883619
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Lupus Nephritis
- Interventions
- Placebo, Nipocalimab, Standard-of-care treatment
- First posted
- 2021-05-12
- Last updated
- 2026-02-27
- Other registries' IDs
- eudract:2020-005568-79
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Complete Renal Response (CRR) | Week 52 | Percentage of participants achieving complete renal response will be reported. |
| Secondary | Percentage of Participants Achieving CRR | Week 24 | Percentage of participants achieving CRR will be reported. |
| Secondary | Percentage of Participants Achieving at Least 50 Percent (%) Decrease in Proteinuria from Baseline, Week 24 and Week 52 | Baseline, Week 24 and Week 52 | Percentage of participants achieving at least 50% decrease in proteinuria will be reported. |
| Secondary | Percentage of Participants Achieving a Sustained Reduction in Steroid Dose Less Than or Equal to (<=)10 milligram (mg)/day of Prednisone or Equivalent | Week 16 to Week 52 | Percentage of participants achieving a sustained reduction in steroid dose \<= 10 mg/day of prednisone or equivalent will be reported. |
| Secondary | Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) | Up to Week 66 | An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. |
| Secondary | Percentage of Participants with Treatment-emergent Serious Adverse Events (TESAEs) | Up to Week 66 | A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. TESAEs are defined as SAEs with onset or worsening on or after date of first dose of study treatment. |
| Secondary | Percentage of Participants with Treatment-emergent AEs Leading to Discontinuation of Study Intervention | Up to Week 52 | Percentage of participants with treatment-emergent AEs leading to discontinuation of study intervention will be reported. |
| Secondary | Percentage of Participants with Treatment-emergent Adverse Events of Special Interests (AESIs) | Up to Week 58 | Percentage of participants with treatment-emergent AESIs will be reported. |
| Secondary | Percentage of Participants with Change from Baseline in Laboratory Parameters Over Time | Up to week 58 | Percentage of participants with change from baseline in laboratory parameters (hematology and chemistry) will be reported. |
| Secondary | Percentage of Participants with Change from Baseline in Vital Sign Parameters Over Time | Up to week 58 | Percentage of participants with change from baseline in vital sign parameters (temperature, pulse/heart rate, respiratory rate, and blood pressure) will be reported. |
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.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT04883619
GET https://conductscience.org/api/trials/v1/NCT04883619/registered