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Trial · NCT03703908

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryThe Number of Subjects With a Reduction in Urine Protein to Creatinine Ratio (UPCR) of at Least 20%Baseline to week 12Number of subjects with a reduction in Urine Protein to Creatinine Ratio (UPCR) of at least 20% , i.e., ≥20%, by Week 12.
SecondaryAchievement of Partial or Complete Remission of UPCR Through Week 12 and Through the End of TreatmentBaseline to week 12
Partial and complete remission were defined as follows: Partial remission (included all of the following): * Reduction from baseline by ≥50% in urine protein:creatinine ratio (UPCR) * Reduction in UPCR to a level that was \<3.5 g/g * Subject could not have been a treatment failure Complete remission (included all of the following): * Reduction in UPCR to \<0.3 g/g * Serum albumin within normal range * For subjects with abnormal serum creatinine levels at baseline, return to normal levels * For subjects with normal serum creatinine levels at baseline, final value within 20% of baseline levels * Subject could not have been a treatment failure
SecondaryProportion of Subjects With Achievement of Complete Remission During the Treatment PeriodBaseline to week 52Complete remission is defined as reduction in urine protein:creatinine ratio (UPCR) to \<0.3 g/g, normal serum albumin, and normal serum creatinine levels or within 20% of baseline levels.
SecondaryTime Taken of Subjects to Achieve Complete Remission During the Treatment PeriodBaseline to week 52Complete remission is defined as reduction in urine protein:creatinine ratio (UPCR) to \<0.3 g/g, normal serum albumin, and normal serum creatinine levels or within 20% of baseline levels.
SecondaryChange From Baseline in Urine Protein:Creatinine Ratio (UPCR) Over TimeBaseline to week 12 and week 52Mean change from baseline in urinary protein:creatinine ratio (UPCR) over time.
SecondaryAssessment of Time to and Proportion of Subjects With Achievement of Partial Remission During the Treatment PeriodBaseline to week 52Partial remission is defined as reduction from baseline by ≥50% in UPCR, reduction in UPCR to a level that was \<3.5 g/g.
SecondaryTime to Rescue TherapyBaseline to week 52Based on Investigator or physician initiation of glucocorticoids or new immunosuppressive agents or new major treatment modalities (e.g. plasmapheresis, dialysis)
SecondaryMean Change From Baseline for eGFR Using the CKD-EPI Cystatin C Equation Over TimeBaseline to Week 12 and Week 52eGFR-Estimated Glomerular Filtration Rate;CKD-EPI=Chronic Kidney Disease Epidemiology Collaboration
SecondaryMean Change From Baseline for the eGFR CKD-EPI Creatinine Equation Over TimeBaseline to Week 12 and Week 52CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular filtration rate
SecondaryMean Change From Baseline for eGFR CKD-EPI Creatinine-Cystatin C Equation Over TimeBaseline to Week 12 and Week 52CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular filtration rate;
SecondaryMean Change From Baseline for the MDRD Creatinine Equation Over TimeBaseline to Week 12 and Week 52MDRD = Modification of Diet in Renal Disease. The mean eGFR (using the MDRD Creatinine equation) change from baseline to Week 12 and Week 52
SecondaryEffect of CCX140-B Treatment on Quality of Life Endpoint SF-36V2Baseline to Week 52
Summary of the Effect of CCX140-B Treatment on Quality of Life Endpoints SF-36V2 for the overall trial SF-36v2: Medical Outcomes Survey Short Form-36 version 2. SF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).
SecondaryEffect of CCX140-B Treatment on Quality of Life Endpoint EQ-5D-5L for the Overall TrialBaseline to Week 12 and Week 52
Summary of the Effect of CCX140-B Treatment on Quality of Life Endpoint EQ-5D-5L for the overall trial EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of : the EQ-5D descriptive system. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine.
SecondaryChanges to Laboratory Parameters Related to Renal Function Including Serum Albumin, Creatinine, Cystatin C, Urinary Albumin:Creatinine Ratio, Total 24-hour Protein Excretion During the TrialBaseline to Day 57Changes to laboratory parameters related to renal function including serum albumin, creatinine, cystatin C, urinary albumin:creatinine ratio, total 24-hour protein excretion during the trial

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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