Trial · NCT05003986
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of interest (AEOIs) | After the last patient has undergone the week 108 visit (Visit 15). | The incidence of TEAEs, SAEs, AEs leading to treatment discontinuation, and AEOIs |
| Primary | Urine protein/creatinine ratio (UP/C) at week 108 | After the last patient has undergone the Week 108 visit (Visit 15) | Change from baseline in UP/C over 108 weeks |
| Secondary | Observed plasma Pharmacokinetic (PK) concentrations | At scheduled Day 1, Day 2 and Week 12 visits for Population 1 and 2. At scheduled Day 1 and Week 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96 visits for Population 3. | Observed plasma PK concentrations at scheduled timepoints and visits |
| Secondary | Steady-state PK parameters area under the plasma concentration-time curve during a dosing interval ([AUCτ]) | Week 108 | Steady-state PK parameters \[AUCτ\] |
| Secondary | Steady-state PK parameters [Cmax_ss] | Week 108 | Maximum steady-state plasma drug concentration \[Cmax\_ss\] |
| Secondary | Steady-state PK parameters [Cmin_ss] | Week 108 | Minimum steady-state plasma drug concentration \[Cmin\_ss\] |
| Secondary | Urine albumin/creatinine ratio (UA/C) over 108 weeks | Week 108 | Change from baseline in UA/C over 108 weeks |
| Secondary | Estimated glomerular filtration rate (eGFR) over 108 weeks | Week 108 | Change from baseline in eGFR over 108 weeks |
| Secondary | Proportion of subjects achieving complete remission of proteinuria | Week 108 | The proportion of subjects achieving complete remission of proteinuria, defined as UP/C \<0.3 g/g over 108 weeks |
| Secondary | Proportion of subjects with FSGS and/or MCD histological patterns achieving partial remission | Week 108 | The proportion of subjects with FSGS and/or MCD histological patterns achieving partial remission defined as UP/C ≤1.5 g/g and \>40% reduction in UP/C over 108 weeks |
| Secondary | Proportion of subjects who discontinue study medication due to inability to tolerate the oral suspension | Week 108 | The proportion of subjects who discontinue study medication due to inability to tolerate the smell, taste, aftertaste, volume of administration, or method of administration of oral suspension in Population 1 and Population 2 |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05003986/registered