Trial · NCT04883619
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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. |
| Secondary | Serum Concentration of Nipocalimab Over Time | Up to Week 58 | Serum concentrations of nipocalimab over time in participants receiving active study intervention will be reported. |
| Secondary | Number of Participants with Antibodies to Nipocalimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [Nabs]) | Up to Week 58 | Number of participants with antibodies to nipocalimab (ADAs and Nabs) in participants receiving active study intervention will be reported. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT04883619/registered