Trial · NCT02141672
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Achieving Complete Renal Remission at 24 Weeks | week 24 | Complete remission is defined as: * Confirmed protein/creatinine ratio of ≤0.5 mg/mg and * eGFR ≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%. Subjects who received rescue medication for lupus nephritis or \>10 mg prednisone for \>3 consecutive days or \>7 days total from 56 days prior to remission assessment until the time of the remission assessment were considered not achieving complete remission. |
| Secondary | Number of Subjects Achieving Complete Renal Remission at 48 Weeks | Week 48 | Complete remission is defined as: * Confirmed protein/creatinine ratio of ≤0.5 mg/mg and * eGFR ≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%. Subjects who received rescue medication for lupus nephritis or \>10 mg prednisone for \>3 consecutive days or \>7 days total from 56 days prior to remission assessment until the time of the remission assessment were considered not achieving complete remission. |
| Secondary | Number of Subjects Achieving Complete Renal Remission at 24 and 48 Weeks in the Presence of Low Dose Steroids | Weeks 24 and 48 | Complete remission is defined as: * Confirmed protein/creatinine ratio of ≤0.5 mg/mg and * eGFR ≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%. Subjects who received rescue medication for lupus nephritis or \>10 mg prednisone for \>3 consecutive days or \>7 days total from 56 days prior to remission assessment until the time of the remission assessment were considered not achieving complete remission. Low-dose steroids is defined as use of ≤5 mg prednisone for 8 weeks leading up to the Week 24 visit date or for 12 weeks leading up to the Week 48 visit date. |
| Secondary | Time to Complete Remission (Number of Weeks) | week 48 | Time to Complete Remission is defined as time from first dose of voclosporin/placebo to UPCR ≤ 0.5mg in the absence of rescue medication. |
| Secondary | Time to Sustained Early Complete Remission (Number of Weeks) | week 48 | Time to Sustained Complete Remission is defined as time from first dose of voclosporin/placebo to UPCR ≤ 0.5mg occurring at week 24 or earlier and sustained until week 48 in the absence of rescue medication. |
| Secondary | Number of Subjects Achieving Sustained Early Complete Remission | week 48 | Sustained early complete remission defined as complete remission that occurred on or before Week 24 and was sustained through Week 48 |
| Secondary | Time to Partial Remission (Number of Weeks) | week 48 | Time to partial Remission is defined as time from first dose of voclosporin/placebo to 50% UPCR reduction sustained until week 48 in the absence of rescue medication. |
| Secondary | Number of Subjects Achieving Partial Remission | week 48 | Partial remission is defined as a 50% reduction in UPCR from baseline at Week 24 and Week 48. |
| Secondary | Number of Subjects Achieving, and Remaining in, Complete Remission | week 48 | Sustained complete remission defined as the first occurrence of complete remission that was sustained through Week 48 |
| Secondary | Duration of Complete Remission (Number of Weeks) | week 48 | Duration of Complete Remission is defined as time of first occurrence of UPCR ≤ 0.5 mg/mg until the second increase above 0.5 mg/mg (i.e. a single occurrence above 0.5 is permitted) or use of rescue medication. |
| Secondary | Number of Subjects Achieving Partial Renal Remission at 24 and 48 Weeks | week 24 and 48 | Number of patients with partial Remission is defined as time from first dose of voclosporin/placebo to 50% UPCR reduction at week 24 or week 48 in the absence of rescue medication. |
| Secondary | Time to Sustained Partial Remission (Number of Weeks) | week 48 | Time to sustained partial Remission is defined as time from first dose of voclosporin/placebo to 50% UPCR reduction sustained until week 48 in the absence of rescue medication. |
| Secondary | Number of Subjects Achieving Sustained Partial Remission | week 48 | Sustained partial remission defined as the first occurrence of partial remission that was sustained through Week 48 |
| Secondary | Time to Sustained Early Partial Remission (Number of Weeks) | week 48 | Time to sustained early partial Remission is defined as time from first dose of voclosporin/placebo to 50% UPCR reduction occurring at week 24 or earlier and sustained until week 48 in the absence of rescue medication. |
| Secondary | Number of Subjects Achieving Sustained Early Partial Remission | week 48 | Early partial remission defined as partial remission that occurred on or before Week 24 and was sustained through Week 48 |
| Secondary | Change From Baseline in UPCR at Weeks 24 and 48 | Baseline, Week 24 and Week 48 | Change from baseline in urine protein creatinine ratio at weeks 24 and 48 |
| Secondary | Change From Baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Score | Baseline, Week 24 and Week 48 | The SELENA-SLEDAI assesses disease activity within the last 10 days. Twenty-four items are scored for nine organ systems, and summed to a maximum of 105 points. A score of 6 is considered clinically significant and indicates active disease. For analysis purposes, a score ≥6 was categorized as "high". The 24 items are as follows: 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, and leukopenia. |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02141672/registered