Trial · NCT03643965
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 | Part A: Ratio of Urine Protein to Creatinine Ratio (UPCR) at 9 Months Compared to Baseline | 9 months | Part A primary endpoint: The ratio of Urine Protein to Creatinine Ratio (UPCR) (based on 24-hour urine collections) at 9 months following the first dose of study drug compared to baseline. Ratio being: UPCR at 9 months in g/gram divided with UPCR at Baseline in g/gram |
| Primary | Part B: Time-weighted Average of Estimated Glomerular Filtration Rate (eGFR) | Up to 2 years and 1 month | Part B Primary endpoint: Time-weighted average of estimated glomerular filtration rate (eGFR) recordings observed at each time point over 2 years. The eGFR (CKD-EPI) at 2 years (which must have been repeated to provide a second value obtained within 14 to 35 days) was the geometric mean of the 2 assessments. |
| Secondary | Part A: Ratio of eGFR at 9 Months | 9 months | Part A: Ratio of eGFR at 9 months compared to baseline calculated using the CKD-EPI formula. |
| Secondary | Part A: Ratio of eGFR at 12 Months | 12 months | Part A: Ratio of eGFR at 12 months compared to baseline calculated using the CKD-EPI formula. |
| Secondary | Part A: Ratio of Urine Albumin to Creatinine Ratio (UACR) at 9 Months | 9 months | Part A: Ratio of urine albumin to creatinine ratio (UACR) at 9 months compared to baseline. |
| Secondary | Part B: Time to 30% Reduction in eGFR | Over 2 years | Part B: Time to 30% reduction from baseline in eGFR (CKD-EPI) confirmed by a second value. For clarity: Please note that the number of patients with a 30% reduction is presented with statistical analysis of the time to 30% reduction. |
| Secondary | Part B: Time to Receiving Rescue Medication. | Over 2 years | Part B: Time from the first dose of study drug until receiving rescue medication. For clarity: Please note that the number of patients receiving rescue medication is presented with statistical analysis of the time to receiving rescue medication. |
| Secondary | Part B: Ratio of UPCR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months | 12, 18 and 24 months | Part B: Ratio of UPCR, UACR, and eGFR (CKD-EPI) compared to baseline averaged over time points between 12 and 24 months, inclusive, following the first dose of study drug |
| Secondary | Part B: Ratio of UACR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months | 12 to 24 months | Part B: Ratio of UPCR, UACR, and eGFR (CKD-EPI) compared to baseline averaged over time points between 12 and 24 months, inclusive, following the first dose of study drug. |
| Secondary | Part B: Ratio of eGFR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months | 12 to 24 months | Part B: Ratio of UPCR, UACR, and eGFR (CKD-EPI) compared to baseline averaged over time points between 12 and 24 months, inclusive, following the first dose of study drug; |
| Secondary | Part B: Proportion of Patients Without Microhematuria | 12 to 24 months | Part B: Proportion of patients without microhematuria in at least 2 of the following time points: 12, 18, and 24 months following the first dose of study drug |
| Secondary | Part B: Short Form 36 (SF-36) Quality of Life Assessment at 9 Months. | 9 months | Part B: Short Form 36 (SF-36) quality of life assessment at 9 and 24 months. The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used. It consists of eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Higher scores indicate better health. Scores represent the percentage of total possible score achieved. |
| Secondary | Part B: Short Form 36 (SF-36) Quality of Life Assessment at 24 Months. | 24 months | Part B: Short Form 36 (SF-36) quality of life assessment at 9 and 24 months. The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used. It consists of eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Higher scores indicate better health. Scores represent the percentage of total possible score achieved. |
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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