Inaxaplin for Kidney Disease

(AMPLIFIED Trial)

Recruiting at 25 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Vertex Pharmaceuticals Incorporated

Disqualifiers: FSGS, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 13 weeks

45 Participants Needed

Trial Summary

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.

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).

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.

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

Treatment Details

Interventions

• Inaxaplin

Trial Overview 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.

Participant Groups

Group I: IXP (Inaxaplin) Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Vertex Pharmaceuticals Incorporated

Lead Sponsor

Trials

267

Recruited

36,100+

Dr. David Altshuler

Vertex Pharmaceuticals Incorporated

Chief Medical Officer since 2020

MD, PhD

Dr. Reshma Kewalramani

Vertex Pharmaceuticals Incorporated

Chief Executive Officer since 2020

MD, trained in internal medicine and nephrology