Atrasentan for IgA Nephropathy
(ALIGN Trial)

Recruiting in Palo Alto (17 mi)

+180 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Chinook Therapeutics, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a medication called atrasentan to help people with a kidney disease called IgA nephropathy. It aims to protect their kidneys by reducing protein in their urine. The study will compare atrasentan to another treatment over a few years. Atrasentan has been studied for its effects on reducing protein in urine and protecting kidney function in patients with diabetic nephropathy.

Eligibility Criteria

This trial is for adults with IgA Nephropathy, a kidney disease, who have a certain level of kidney function and are on stable doses of specific blood pressure medications. They must not be pregnant or planning to become so during the study. People with high blood pressure, severe anemia, recent cancer (except some skin cancers), other chronic kidney diseases, or those who've had organ transplants can't join.

Inclusion Criteria

You have more than 1 gram of protein in your urine per day, as measured by a 24-hour urine collection test.

Willing and able to provide informed consent and comply with all study requirements

My kidney function test shows an eGFR of 30 or higher.

+9 more

Exclusion Criteria

I have a significant history of liver problems.

I have had cancer in the last 5 years, but not skin cancer or treated cervical cancer.

I haven't taken any experimental or approved IgAN treatments, except RAS inhibitors, recently.

+8 more

Participant Groups

The ALIGN Study is testing Atrasentan against a placebo in patients at risk of worsening kidney function due to IgA Nephropathy. It's a phase 3 trial where participants won't know if they're getting the actual drug or a dummy pill (placebo). The goal is to see if Atrasentan is effective and safe.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AtrasentanExperimental Treatment1 Intervention

Double-blind Period: Once daily oral administration of 0.75 mg atrasentan for 132 weeks. Open-label Extension Period: Once daily oral administration of 0.75 mg atrasentan for 48 weeks after completion of 132 weeks on atrasentan or placebo.

Group II: PlaceboPlacebo Group1 Intervention

Double-blind Period: Once daily oral administration of placebo for 132 weeks