Trial · NCT07340463
The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment
NCT07340463, Phase 2, Recruiting, Nanjing University School of Medicine
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment. Trials, record NCT07340463. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07340463
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment
- NCT number
- NCT07340463
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 50 participants, estimated
- Lead sponsor
- Nanjing University School of Medicine
- Conditions
- Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
- Interventions
- Glucocorticoids, belimumab, Telitacicept, Mycophenolate mofetil (MMF)
- First posted
- 2026-01-14
- Last updated
- 2026-03-12
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Renal Response (CRR) Rate at Month 6 | From Baseline to Month 6 | Proportion of patients achieving Complete Renal Response. CRR is defined as: 24-hour urine protein \< 0.5 g/d, AND estimated glomerular filtration rate (eGFR) ≥ 85% of the baseline value, AND no receipt of rescue therapy or premature withdrawal from treatment. |
| Secondary | Partial Renal Response (PRR) Rate at Months 1, 2, 3, 4, 5, and 6 | From Baseline to Months 1, 2, 3, 4, 5, and 6 | Proportion of patients achieving Partial Renal Response. PRR is defined as: ≥50% reduction in 24-hour urine protein from baseline, AND eGFR ≥ 85% of the baseline value, AND no receipt of rescue therapy or premature withdrawal from treatment. |
| Secondary | Overall Renal Response (ORR) Rate at Months 1, 2, 3, 4, 5, and 6 | From Baseline to Months 1, 2, 3, 4, 5, and 6 | Proportion of patients achieving Overall Renal Response. ORR is defined as achieving either Partial Renal Response (PRR) or Complete Renal Response (CRR). |
| Secondary | Time to Achieve Complete or Partial Renal Response | From randomization up to Month 6 | Time from randomization to the first achievement of either Complete Renal Response or Partial Renal Response. |
| Secondary | Proportion of Patients with Renal-Related Events by Month 6 | From Baseline to Month 6 | Proportion of patients experiencing at least one renal-related event. Renal-related event is defined as: ① Death; ② Worsening proteinuria (≥50% increase in 24-hour urine protein from baseline AND value ≥3 g/g); ③ Worsening eGFR (≥30% decrease in eGFR from baseline AND value \<60 mL/min/1.73 m²); ④ Receipt of rescue therapy. |
| Secondary | Change from Baseline in 24-hour Urine Protein Quantification | Baseline, Months 1, 2, 3, 4, 5, and 6 | Absolute change and ratio from baseline in 24-hour urine protein (g/d) at each visit. |
| Secondary | Change from Baseline in Estimated Glomerular Filtration Rate | Baseline, Months 1, 2, 3, 4, 5, and 6 | Change from baseline in estimated glomerular filtration rate (eGFR, mL/min/1.73 m²) at each visit. |
| Secondary | Incidence of Adverse Events During the Treatment Period | From first dose until 30 days after the last dose or the Month 6 visit, whichever is later | Proportion of patients experiencing at least one adverse event, serious adverse event, or adverse event of special interest (e.g., infusion/injection reactions, infections, new-onset hypertension/diabetes). Assessed based on abnormal findings in physical exams, vital signs, and laboratory tests (complete blood count, biochemistry, urinalysis). |
Source ClinicalTrials.gov
Outcomes0
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.
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/NCT07340463
GET https://conductscience.org/api/trials/v1/NCT07340463/registered