Inaxaplin for Kidney Disease
(AMPLIFIED Trial)

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Vertex Pharmaceuticals Incorporated

Disqualifiers: FSGS, Uncontrolled hypertension, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Eligibility Criteria

This trial is for individuals with APOL1-mediated kidney disease, specifically those who have certain genetic markers (G1/G1, G2/G2, or G1/G2) and a minimum kidney function level (eGFR ≥ 25 mL/min/1.73m^2).

Inclusion Criteria

My APOL1 genotype is G1/G1, G2/G2, or G1/G2.

My kidney function test shows an eGFR of 25 mL/min or higher.

Exclusion Criteria

My blood pressure is not well-controlled.

My kidney condition is diagnosed as FSGS not caused by APOL1 gene changes.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of Inaxaplin (IXP) once daily for 13 weeks

13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The study tests the effectiveness and safety of a drug called Inaxaplin in patients with proteinuric APOL1-mediated kidney disease to see how well it works and what side effects it might have.

1Treatment groups

Experimental Treatment

Group I: IXP (Inaxaplin)Experimental Treatment1 Intervention

Participants with proteinuric APOL1-mediated kidney disease (AMKD) and who have either none or 1 of the following comorbidities: Type 2 diabetes mellitus (T2DM) or sickle cell disease (SCD) or human immunodeficiency virus (HIV) or lupus nephritis (LN), will receive a single dose of IXP once daily, for 13 weeks.