NCT06794996CompletedPhase 2
A Phase 2b, Open-label Study to Evaluate the Efficacy and Safety of Inaxaplin in Subjects With Proteinuric APOL1-mediated Kidney Disease With or Without Comorbidities That May Independently Contribute to Chronic Kidney Disease
Vertex Pharmaceuticals Incorporated68 sites in 1 country42 target enrollmentStarted: February 4, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 42
- Locations
- 68
- Primary Endpoint
- Percent Change in Urine Albumin-Creatinine Ratio (UACR)
Study Overview
Brief Summary
The purpose of the study is to evaluate the efficacy, safety, and tolerability of Inaxaplin (IXP) in participants with proteinuric APOL1- mediated kidney disease (AMKD).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 67 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant has an APOL1 genotype of G1/G1, G2/G2, or G1/G2 obtained with a Vertex designated investigational clinical study assay
- •Estimated Glomerular Filtration Rate (eGFR) of greater than or equal to (≥) 25 milliliter per minute (mL/min)/1.73m^2 at screening
Exclusion Criteria
- •Evidence of Focal Segmental Glomerulosclerosis (FSGS) with a known cause other than due to APOL1 risk variants
- •Uncontrolled hypertension
- •Other protocol defined Inclusion/Exclusion criteria may apply.
Arms & Interventions
IXP (Inaxaplin)
Experimental
Participants with proteinuric APOL1-mediated kidney disease (AMKD) with or without the comorbidity of Type 2 diabetes mellitus (T2DM) will receive a single dose of IXP once daily, for 13 weeks.
Intervention: Inaxaplin (Drug)
Outcomes
Primary Outcomes
Percent Change in Urine Albumin-Creatinine Ratio (UACR)
Time Frame: Baseline and At Week 13
Secondary Outcomes
- Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Baseline Up To Week 17)
Investigators
Study Sites (68)
Loading locations...
Similar Trials
Recruiting
Phase 2
An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects with Systemic SclerosisSystemic SclerosisJPRN-jRCT2031210481ishiura Tomoyuki8
Active, not recruiting
Phase 1
Phase II two-arm study of AZD4635 in combination with durvalumab and in combination with cabazitaxel and durvalumab in patients with mCRPCProgressive Metastatic Castrate-Resistant Prostate CancerMedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-000209-10-DKAstraZeneca AB80
Active, not recruiting
Phase 1
Phase II two-arm study of AZD4635 in combination with durvalumab and in combination with cabazitaxel and durvalumab in patients with mCRPCProgressive Metastatic Castrate-Resistant Prostate CancerMedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-000209-10-DEAstraZeneca AB80
Active, not recruiting
Phase 1
Phase II two-arm study of AZD4635 in combination with durvalumab and in combination with cabazitaxel and durvalumab in patients with mCRPCProgressive Metastatic Castrate-Resistant Prostate CancerMedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-000209-10-NLAstraZeneca AB80
Active, not recruiting
Phase 1
A Phase 2, Open label Study to Assess the Efficacy and Safety of Tenalisib(RP6530) in Patients with Relapsed/Refractory Chronic LymphocyticLeukemia (CLL)Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)MedDRA version: 21.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864EUCTR2019-003622-25-PLRhizen Pharmaceuticals SA61