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History of Changes for Study: NCT05312879
Phase 2/3 Adaptive Study of VX-147 in Adults With APOL1- Mediated Proteinuric Kidney Disease
Latest version (submitted November 23, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 28, 2022 None (earliest Version on record)
2 April 20, 2022 Recruitment Status, Study Status, IPDSharing and Contacts/Locations
3 April 29, 2022 Study Status and Contacts/Locations
4 May 16, 2022 Contacts/Locations and Study Status
5 June 6, 2022 Contacts/Locations and Study Status
6 June 29, 2022 Contacts/Locations and Study Status
7 August 25, 2022 Contacts/Locations and Study Status
8 September 12, 2022 Contacts/Locations and Study Status
9 October 6, 2022 Contacts/Locations and Study Status
10 October 17, 2022 Contacts/Locations and Study Status
11 November 23, 2022 Contacts/Locations and Study Status
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Study NCT05312879
Submitted Date:  March 28, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: VX21-147-301
Brief Title: Phase 2/3 Adaptive Study of VX-147 in Adults With APOL1- Mediated Proteinuric Kidney Disease
Official Title: A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Subjects Aged 18 Years and Older With APOL1-mediated Proteinuric Kidney Disease
Secondary IDs: 2021-004762-35 [EudraCT Number]
Open or close this module Study Status
Record Verification: March 2022
Overall Status: Not yet recruiting
Study Start: April 2022
Primary Completion: May 2026 [Anticipated]
Study Completion: June 2026 [Anticipated]
First Submitted: March 28, 2022
First Submitted that
Met QC Criteria:
March 28, 2022
First Posted: April 6, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
March 28, 2022
Last Update Posted: April 6, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Vertex Pharmaceuticals Incorporated
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of VX-147 in participants aged 18 years and older with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease.
Detailed Description:
Open or close this module Conditions
Conditions: Proteinuric Kidney Disease
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model: Sequential Assignment
Number of Arms: 4
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 466 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Phase 2: VX-147
Participants will be randomized to receive different dose levels of VX-147.
Drug: VX-147
Tablets for oral administration.
Placebo Comparator: Phase 2: Placebo
Participants will receive placebo matched to VX-147.
Drug: Placebo
Tablets for oral administration.
Experimental: Phase 3: VX-147
Participants will receive VX-147 with the dose to be based on the outcome of Phase 2.
Drug: VX-147
Tablets for oral administration.
Placebo Comparator: Phase 3: Placebo
Participants will receive placebo matched to VX-147.
Drug: Placebo
Tablets for oral administration.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Percent Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48 (Assessed at the Week 48 Interim Analysis)
[ Time Frame: From Baseline at Week 48 ]

2. Estimated Glomerular Filtration Rate (eGFR) Slope Assessed at the Week 48 Interim Analysis
[ Time Frame: From Baseline Through >= Week 48 ]

3. eGFR Slope Assessed at Study Completion
[ Time Frame: From Baseline Through Study Completion (Approximately 2 Years After the Last Participant Enrolls) ]

Secondary Outcome Measures:
1. Time to Composite Clinical Outcome of a Sustained Decline of >=30 Percent (%) in eGFR, the Onset of end-stage Kidney Disease or Death
[ Time Frame: From Baseline Through Study Completion (Approximately 2 Years After the Last Participant Enrolls) ]

2. Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)
[ Time Frame: Day 1 Through Study Completion (Approximately 2 Years After the Last Participant Enrolls) ]

3. Maximum Observed Plasma Concentration (Cmax) of VX-147
[ Time Frame: Day 1 and Week 12 ]

4. Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-147
[ Time Frame: Day 1 and Week 12 ]

5. Observed Pre-dose Plasma Concentration (Ctrough) of VX-147
[ Time Frame: Day 1 up to Week 48 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Key Inclusion Criteria:

  • APOL1 genotype of G1/G1, G2/G2, or G1/G2
  • Proteinuric kidney disease

Key Exclusion Criteria:

  • Solid organ or bone marrow transplant
  • Uncontrolled hypertension
  • Diagnosis of diabetes mellitus
  • Known underlying cause of kidney disease including but not limited to sickle cell disease

Other protocol defined Inclusion/Exclusion criteria apply.

Open or close this module Contacts/Locations
Central Contact Person: Medical Information
Telephone: 617-341-6777
Email: medicalinfo@vrtx.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent research/clinical-trial-data-sharing
Open or close this module References
Citations:
Links:
Available IPD/Information:

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