Trial · NCT04181762
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 | Percentage of Participants Achieving Complete Renal Response (CRR) at Week 52 | Baseline, Week 52 | Complete Renal Response (CRR) is a composite endpoint defined as: * Estimated Glomerular Filtration Rate (eGFR) \>= 60 mL/min/1.73 m\^2 or no less than 85% of core Baseline values and * 24-hour Urine-to-Protein Creatinine Ratio (UPCR) =\< 0.5mg/mg * No treatment discontinuation before Week 52 * The subject did not receive more than 10 mg/day prednisone or equivalent for \>= 3 consecutive days or for \>= 7 days in total during Week 44 through Week 52. Non-responder imputation (NRI) was used for participants who did not have the required data to compute responses at Week 52 or who had discontinued study treatment before Week 52. A logistic regression model was used for the analysis of this endpoint. |
| Secondary | Change From Baseline in 24-hour Urine Protein-to Creatinine Ratio (UPCR) | Baseline, Week 52 | Urine Protein-to-Creatinine Ratio (UPCR) was determined by a central laboratory by dividing the protein concentration by the creatinine concentration as measured in the urine collected (24-hour urine collection sample). |
| Secondary | Percentage of Participants Achieving Partial Renal Response (PRR) at Week 52 | Baseline, Week 52 | Partial Renal Response (PRR) is a composite endpoint defined as: * \>= 50% reduction in 24-hour Urine-to-Protein Creatinine Ratio (UPCR) to sub-nephrotic levels (=\< 3 mg/mg) and * Estimated Glomerular Filtration Rate (eGFR) \>= 60 mL/min/1.73 m\^2 or no less than 85% of Baseline |
| Secondary | Average Daily Dose of Oral Corticosteroids | Week 16 to Week 52 | Average daily dose of oral corticosteroids doses was used to assess efficacy of secukinumab compared to placebo in the averaged daily dose of oral corticosteroids administered between Week 16 and Week 52. |
| Secondary | Percentage of Participants Achieving Partial Renal Response (PRR) at Week 24 | Baseline, Week 24 | Partial Renal Response (PRR) is a composite endpoint defined as: * \>= 50% reduction in 24-hour Urine-to-Protein Creatinine Ratio (UPCR) to sub-nephrotic levels (=\< 3 mg/mg) and * Estimated Glomerular Filtration Rate (eGFR) \>= 60 mL/min/1.73 m\^2 or no less than 85% of Baseline |
| Secondary | Incidence Rate of Participants Achieving Complete Renal Response (CRR) up to Week 52 | Baseline to Week 52 | Time to achieve Complete Renal Response (CRR) up to week 52 was evaluated by 4-week interval by using Kaplan-Meier estimates. Participants who did not achieve CRR were censored at the date of their last non-missing CRR result (including participants who completed week 52 without achieving CRR). * Subjects at risk = Subjects who did not achieve CRR and were not censored before or at the start of the specified interval. Participants had an event when achieving CRR. * Incidence rate (%) = (number of subjects with event/number of subjects at risk) x 100. |
| Secondary | Incidence Rate of Participants Achieving Partial Renal Response (PRR) up to Week 52 | Baseline to Week 52 | Time to achieve Partial Renal Response (PRR) up to week 52 was evaluated by 4-week interval by using Kaplan-Meier estimates. Participants who did not achieve PRR were censored at the date of their last non-missing PRR result (including participants who completed week 52 without achieving PRR). Participants had event when achieving PRR. * Subjects at risk = Subjects who did not achieve PRR and were not censored before or at the start of the specified interval. * Incidence rate (%) = (number of subjects with event/ number of subjects at risk) x 100. |
| Secondary | Time to Achieve First Morning Void Urine Protein-to-Creatinine Ratio (UPCR) <= 0.5 mg/mg up to Week 52 | Baseline to Week 52 | Time to achieve first morning void Urine Protein-to-Creatinine Ratio (UPCR) \<= 0.5 mg/mg up to week 52 was evaluated by 4-week interval by using Kaplan-Meier estimates. Participants who did not achieve UCPR were censored at the date of their last non-missing UCPR result (including participants who completed week 52 without achieving UCPR). Participants had event when achieving UCPR. * Subjects at risk = Subjects who did not achieve UCPR and were not censored before or at the start of the specified interval. * Incidence rate (%) = (number of subjects with event/ number of subjects at risk) x 100. |
| Secondary | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Mean Change From Baseline up to Week 52 | Baseline, Week 12, Week 24, Week 36, Week 52 | The FACIT-Fatigue is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the past week. The purpose of the FACIT-Fatigue in this study was to assess the impact of fatigue on subjects with lupus nephritis (LN). The level of fatigue was measured on a 5-point Likert scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much) based on their experience of fatigue during the past 2 weeks. The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. FACIT-Fatigue scale score range from 0 to 52, where higher scores represent less fatigue. |
| Secondary | Short Form Health Survey (SF-36) Version 2 (Acute Form) Mean Change From Baseline in Physical Component Score (PCS) up to Week 52 | Baseline, Week 12, Week 24, Week 36, Week 52 | The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). In this trial, SF-36-PCS responder (improvement of \>= 2.5 points) were evaluated. Responses to items allow for direct calculation of scale scores, while the physical component summary (PCS) scores are computed from weighted scale scores. For all scales and summary measures, higher scores indicate better health outcomes (PCS scores range 0 to 100). |
| Secondary | Lupus Quality of Life (LupusQoL) Physical Health Score Mean Change From Baseline up to Week 52 | Baseline, Week 12, Week 24, Week 36, Week 52 | The LupusQoL is a disease-specific, 34-item, self-report questionnaire designed to measure the health-related quality of life (HRQoL) of subjects with SLE within 8 domains (i.e., physical health (8 items), emotional health (6 items), body image (5 items), pain (3 items), planning (3 items), fatigue (4 items), intimate relationships (2 items), and burden to others (3 items)). Responses are based on a 5-point Likert scale where 0 (all of the time) to 4 (never). Each domain of the LupusQoL was scored separately. Transformed scores range from 0 (worst HRQoL) to 100 (best HRQoL). |
| Secondary | Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) | From first dose of study treatment up to approximately 2 years | The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. |
| Secondary | Percentage of Participants With Complete Renal Response (CRR) at Week 104 Within Those Who Had Achieved CRR at Week 52 in the Secukinumab Group | Week 52 to Week 104 | The percentage of participants with maintained renal response (CRR) at Week 104 in the secukinumab group was evaluated |
| Secondary | Percentage of Participants With Improved or Maintained Response (PRR or CRR) at Week 104 in Those Who Had Achieved at Least PRR at Week 52 in the Secukinumab Group | Week 52 to Week 104 | The percentage of participants with improved or maintained renal response (CRR) at Week 104 in the secukinumab group was evaluated |
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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