Trial · NCT03021499
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adjudicated Renal Response at Week 52 | 52 Weeks | The primary efficacy endpoint was the number of subjects showing renal response at Week 52. Renal response was adjudicated based on blinded data by an independent Clinical Endpoints Committee based on meeting the following criteria * UPCR of ≤0.5 mg/mg \& * eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of \>20% \& * Received no rescue medication for LN \& * Did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during Weeks 44 through 52, prior to assessment Note:To be disqualified from renal response, the subject had to fail both eGFR measures (i.e., confirmed eGFR \<60 mL/min/1.73 m2 \& confirmed \>20% drop from baseline) \& have an associated treatment-related or disease-related AE that impacted eGFR Withdrawals prior to Week 52 with insufficient Week 52 data to determine response were defined non responders. Subjects who discontinued study drug but continued to attend study visits had their data assessed for response |
| Secondary | Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less | 52 Weeks | Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less |
| Secondary | Time to Urine Protein Creatinine Ratio of ≤0.5 mg/mg (Number of Days) | 52 Weeks | Time in days to reduction in Urine Protein Creatinine Ratio to decrease to 0.5 mg/mg or less. |
| Secondary | Number of Participants With Renal Response at Week 24 | Week 24 | Number of subjects showing renal response at Week 24. Renal response was adjudicated based on blinded data by an Independent Clinical Endpoints Committee based on the following criteria: UPCR of ≤0.5 mg/mg, \& eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of \>20%, and Received no rescue medication for LN \& Did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during Weeks 16 through 24, just prior to the renal response assessment. Note:To be disqualified from renal response, the subject had to fail both eGFR measures (i.e., confirmed eGFR \<60 mL/min/1.73 m2 AND confirmed \>20% drop from BL) \& have an associated treatment-related or disease-related AE that impacted eGFR. Subjects who withdrew prior to the Week 24 assessment and provided insufficient Week 24 data to determine response were defined as non-responders. Subjects who discontinued study drug but continued to attend study visits had their data assessed for response. |
| Secondary | Number of Subjects With Partial Renal Response at Weeks 24 & 52 | Weeks 24 and 52 | Number of subjects with partial Renal Response (defined as a 50% reduction in UPCR from baseline) at Week 24 and at Week 52. Baseline UPCR is the average of 2 pre-randomisation values. |
| Secondary | Number of Subjects Achieving, and Remaining in, Renal Response (Urine Protein Creatinine Ratio ≤0.5 mg/mg) | Week 52 | Number of subjects achieving, and remaining in, renal response (Urine Protein Creatinine ratio ≤0.5 mg/mg) |
| Secondary | Duration of Renal Response (Number of Days) | Week 52 | Duration in days until second occurrence of UPCR \>0.5 mg/mg in those subjects who achieve a reduction in UPCR to below 0.5 mg/mg |
| Secondary | Number of Subjects Achieving 50% Reduction in Urine Protein Creatinine Ratio | 52 Weeks | Number of subjects achieving 50% reduction in Urine Protein Creatinine ratio |
| 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 | Change From Baseline in eGFR | Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52. | Change from baseline by visit in estimated Glomerular Filtration rate. eGFR is corrected to a maximum value of 90 mL/min/1.73 m2 |
| 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 | 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 Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA - SLEDAI) | Week 24 and Week 52 | Change from baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score at Week 24 and 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. |
| Secondary | Change From Baseline in Patient Reported Outcomes | 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. |
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.
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