Atrasentan for Kidney Disease

(AFFINITY Trial)

Recruiting at 46 trial locations

Overseen By Lesley Inker

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Chinook Therapeutics U.S., Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a pill called atrasentan that may help people with certain kidney diseases by reducing harmful protein levels in their urine. It targets patients whose kidney function is getting worse despite standard treatments. The goal is to see if this medication can protect their kidneys.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for adults with certain kidney diseases (like IgA Nephropathy, FSGS, Alport Syndrome) who have protein in their urine and are at risk of worsening kidney function. Participants must meet specific criteria including age limits (18+ or 18-70 depending on the condition), a confirmed diagnosis through biopsy, stable blood filtration rates, and be on steady doses of certain diabetes or blood pressure medications.

Inclusion Criteria

I have been on a steady dose of an SGLT2 inhibitor for 3 months.

Your body mass index (BMI) is less than or equal to 40 kg/m2.

I have been on a stable dose of RAS inhibitor therapy for at least 12 weeks.

Exclusion Criteria

I have a chronic kidney condition not caused by my current kidney disease.

I have a significant history of liver problems.

Treatment Details

Interventions

• Atrasentan (Endothelin Receptor Antagonist)

Trial Overview The AFFINITY Study is testing Atrasentan's effectiveness and safety in patients with different types of proteinuric glomerular diseases. It's an open-label phase 2 study which means everyone knows they're getting Atrasentan and it’s early in the drug testing process to see if it works well.

Participant Groups

Group I: Atrasentan 1.5 mg Experimental Treatment 1 Intervention

Once daily oral administration 1.5 mg atrasentan (FSGS cohorts only)

Group II: Atrasentan 0.75 mg Experimental Treatment 1 Intervention

Once daily oral administration of 0.75 mg atrasentan

Who Is Running the Clinical Trial?

Chinook Therapeutics U.S., Inc.

Lead Sponsor

Trials

2

Recruited

510+

Chinook Therapeutics, Inc.

Lead Sponsor

Trials

10

Recruited

1,100+

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD