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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 November 2022 |
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Main ID: |
NCT04340362 |
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Date of registration:
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07/04/2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase 2a Study of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis
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Scientific title:
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A Phase 2a, Open-label, Single-arm, 2-Part Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis |
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Date of first enrolment:
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June 8, 2020 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT04340362 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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France
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Puerto Rico
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- APOL1 genotype of G1/G1, G2/G2, or G1/G2
- FSGS diagnosed by kidney biopsy
Key Exclusion Criteria:
- Evidence of non-APOL1-mediated FSGS
- Subjects with known sickle cell disease
- Solid organ or Bone marrow transplant
Other protocol defined Inclusion/Exclusion criteria may apply.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Glomerulosclerosis, Focal Segmental
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Intervention(s)
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Drug: VX-147
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Primary Outcome(s)
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Percent Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 13
[Time Frame: Baseline, Week 13]
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Secondary Outcome(s)
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Area under the concentration versus time curve during a dosing interval (AUCtau) of VX-147
[Time Frame: Pre-dose up to Week 13]
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Safety and tolerability as assessed by number of subjects with adverse events (AEs) and serious adverse events (SAEs)
[Time Frame: From Baseline up to Week 17]
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Observed pre-dose concentration (Ctrough) of VX-147
[Time Frame: Pre-dose]
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Maximum observed concentration (Cmax) of VX-147
[Time Frame: Pre-dose up to Week 13]
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Secondary ID(s)
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2020-000185-42
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VX19-147-101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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