Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases : A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects With Selected Proteinuric Glomerular Diseases
This is a multicenter, open-label, 112-week study of sparsentan in approximately 67 pediatric subjects aged ≥1 year to <18 years with selected proteinuric glomerular diseases, divided into 3 populations, defined as follows:Population 1: Subjects with selected proteinuric glomerular diseases associated with Focal Segmental Glomerulosclerosis (FSGS) and Minimal Change Disease (MCD) histological patternsPopulation 2: Subjects with kidney biopsy-confirmed immunoglobulin A nephropathy (IgAN), immunoglobulin A vasculitis (IgAV), or Alport syndrome (AS)Population 3: Subjects with kidney biopsy-confirmed IgANThe study will evaluate long-term safety, tolerability, and efficacy with pharmacokinetic (PK) evaluations at Day 1 (Baseline), Day 2 (Visit 4), and Week 12 (Visit 9) in Population 1 and Population 2. In Population 3, PK values will be evaluated at Day 1 (Baseline) and at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96. For Population 1 and Population 2, subjects will be enrolled in 3 cohorts based on age ranges. For Population 3, subjects will be enrolled in one cohort.Study Enrollment:Population 1: FSGS and/or MCD (30 subjects total)Cohort 1 (6 subjects): ≥8 years to <18 yearsCohort 2 (18 subjects): ≥3 years to <8 yearsCohort 3 (6 subjects): ≥1 year to <3 yearsPopulation 2: IgAN, IgAV, or AS (27 subjects total)Cohort 1 (9 subjects): ≥8 years to <18 yearsCohort 2 (12 subjects): ≥5 years to <8 yearsCohort 3 (6 subjects): ≥2 years to <5 yearsPopulation 3: IgAN (10 subjects total)10 subjects: ≥8 years to <18 years.
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 19. März Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: August 13, 2021, Last downloaded: ClinicalTrials.gov processed this data on March 27, 2024, Last updated: March 27, 2024 |
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| Study ID: |
NCT05003986 |
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| Veröffentlichungen zur Studie: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CTG000096601 |
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| 245 | 1 | 0 | |a Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases |b A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects With Selected Proteinuric Glomerular Diseases |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: August 13, 2021, Last downloaded: ClinicalTrials.gov processed this data on March 27, 2024, Last updated: March 27, 2024 | ||
| 520 | |a This is a multicenter, open-label, 112-week study of sparsentan in approximately 67 pediatric subjects aged ≥1 year to <18 years with selected proteinuric glomerular diseases, divided into 3 populations, defined as follows:Population 1: Subjects with selected proteinuric glomerular diseases associated with Focal Segmental Glomerulosclerosis (FSGS) and Minimal Change Disease (MCD) histological patternsPopulation 2: Subjects with kidney biopsy-confirmed immunoglobulin A nephropathy (IgAN), immunoglobulin A vasculitis (IgAV), or Alport syndrome (AS)Population 3: Subjects with kidney biopsy-confirmed IgANThe study will evaluate long-term safety, tolerability, and efficacy with pharmacokinetic (PK) evaluations at Day 1 (Baseline), Day 2 (Visit 4), and Week 12 (Visit 9) in Population 1 and Population 2. In Population 3, PK values will be evaluated at Day 1 (Baseline) and at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96. For Population 1 and Population 2, subjects will be enrolled in 3 cohorts based on age ranges. For Population 3, subjects will be enrolled in one cohort.Study Enrollment:Population 1: FSGS and/or MCD (30 subjects total)Cohort 1 (6 subjects): ≥8 years to <18 yearsCohort 2 (18 subjects): ≥3 years to <8 yearsCohort 3 (6 subjects): ≥1 year to <3 yearsPopulation 2: IgAN, IgAV, or AS (27 subjects total)Cohort 1 (9 subjects): ≥8 years to <18 yearsCohort 2 (12 subjects): ≥5 years to <8 yearsCohort 3 (6 subjects): ≥2 years to <5 yearsPopulation 3: IgAN (10 subjects total)10 subjects: ≥8 years to <18 years | ||
| 650 | 2 | |a Glomerulosclerosis, Focal Segmental | |
| 650 | 2 | |a Nephritis, Hereditary | |
| 650 | 2 | |a Glomerulonephritis, IGA | |
| 650 | 2 | |a Nephrosis, Lipoid | |
| 650 | 2 | |a Vasculitis | |
| 650 | 2 | |a IgA Vasculitis | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Recruiting | |
| 650 | 4 | |a Phase: Phase 2 | |
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