Trial · NCT05003986
Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases
NCT05003986, Phase 2, Recruiting, Travere Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases. Trials, record NCT05003986. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05003986
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases
- NCT number
- NCT05003986
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 67 participants, estimated
- Lead sponsor
- Travere Therapeutics, Inc.
- Conditions
- Focal Segmental Glomerulosclerosis, Minimal Change Disease, Immunoglobulin A Nephropathy, IgA Vasculitis, Alport Syndrome
- Interventions
- Sparsentan, Sparsentan, Sparsentan
- First posted
- 2021-08-13
- Last updated
- 2026-05-12
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05003986
GET https://conductscience.org/api/trials/v1/NCT05003986/registered