Trial · NCT06406205
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Complete Renal Remission at Week 52 | Week 52 | The primary efficacy endpoint was the number of subjects showing complete renal response at Week 52. Complete renal response was adjudicated based on blinded data by an independent Clinical Endpoints Committee based on meeting the following criteria： UPCR of ≤0.5 g/g \& eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of \>20% |
| Secondary | Time to Urine Protein Creatinine Ratio of ≤0.5 g/g(Number of Days) | 52 Weeks | Time in days to reduction in Urine Protein Creatinine Ratio to decrease to 0.5 g/g or less. |
| Secondary | Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 g/g or Less | 52 Weeks | Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 g/g or Less |
| Secondary | Number of Subjects With Partial Renal Response at Week 52 | Week 52 | Number of subjects with partial Renal Response (defined as a 50% reduction in UPCR from baseline) at Week 52. Baseline UPCR is the average of 2 pre-randomisation values. |
| Secondary | Time to 50% Reduction in UPCR (Number of Days) | 52 Weeks | Time in days to reduction in Urine Protein Creatinine Ratio to decrease by 50% compared to baseline. Baseline is the average of two pre-randomisation values. |
| Secondary | Number of Subjects With Partial Renal Response at Week 24 | Week 24 | Number of subjects with partial Renal Response (defined as a 50% reduction in UPCR from baseline) at Week 24. Baseline UPCR is the average of 2 pre-randomisation values. |
| Secondary | Number of Subjects With Renal Response With Low Dose Steroids | Week 24 and Week 52 | Programmed Renal Response whilst on low dose steroids (\<2.5 mg/day) for the preceding 8 Weeks at Weeks 24 and 52 |
| Secondary | Change From Baseline in UPCR | Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52. | Change from baseline by visit in Urine Protein Creatinine Ratio. Baseline is the average of two pre-randomisation values. |
| Secondary | Proportion of subjects experiencing a confirmed 30% decrease or more fom baseline in eGFR at each timepoint | Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52. | Number of subjects with a 30% or more decrease in estimated glomerular filtration rate compared to baseline at each visit time point that meets diagnostic criteria. |
| Secondary | Change from baseline by visit in Serum Creatinine, Urine Protein, and estimated Glomerular Filtration rate. | Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52. | Change from baseline by visit in Serum Creatinine, Urine Protein, and estimated Glomerular Filtration rate. eGFR is corrected to a maximum value of 90 mL/min/1.73 m2 |
| Secondary | Change From Screening in Immunology Parameters (Complement 3 (C3), C4, and Anti-Double-Stranded DNA) | Week 24 and Week 52 | Change from baseline by visit in Immunology Parameters (Complement 3 (C3), C4, and Anti-Double-Stranded DNA). The immunological baseline data is the numerical value during the screening period. |
| Secondary | Change From Baseline in Patient Reported Outcomes | Week 12, Week 24 and Week 52 | Health-related quality of life (HRQoL) information was collected using the Short Form Health Survey (SF-36) HRQoL assessment and the LupusPRO (v1.7) assessment. The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. Scoring ranges from 0 to 100 with higher scores reflecting better health. LupusPro assessment is a patient-reported questionnaire regarding the effect of lupus or its treatment on the patient's health, quality of life, and the medical care received related to lupus. The questionnaire consists of 43 questions within 8 HRQOL domains and 4 Non-HRQoL domains. Scores range from 0 to 100 with higher scores reflecting better quality of life. |
| Secondary | Change From Baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA - SLEDAI) | Week 24 and Week 52 | The SELENA-SLEDAI tool is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with lupus. A patient's SELENA-SLEDAI total score is the sum of all marked lupus related descriptors (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, leukopenia). A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT06406205/registered