🏛️ Verified NIH Record • Updated 2026-06-01

Atrasentan in Patients With IgA Nephropathy (NCT04573478)

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy at Risk of Progressive Loss of Renal Function

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Novartis Pharmaceuticals

🩺 Plain-English Summary (8th-Grade Level)

The ALIGN Study is a phase 3, double-blind, placebo-controlled study to compare the efficacy and safety of atrasentan to placebo in patients with IgA nephropathy (IgAN) at risk of progressive loss of renal function.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (15 items) and avoid the listed exclusions (36 items).

Location: University of Alabama at Birmingham — Birmingham, Alabama

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria: Double-blind period:
  • Concurrent diagnosis of another cause of chronic kidney disease including diabetic kidney disease or another primary glomerulopathy.
  • Clinical diagnosis of nephrotic syndrome.
  • BNP value of \> 200 pg/mL at Screening.
  • Platelet count \<80,000 per μL at Screening.
  • History of organ transplantation (subjects with history of corneal transplant are not excluded).
  • Use of systemic immunosuppressant medications.
  • Hemoglobin below 9 g/dL at Screening or prior history of blood transfusion for anemia within 3 months of Screening. Open-label period:
  • eGFR \< 25 mL/min/1.73m\^2 or evidence of rapidly decreasing eGFR, including unrecovered acute kidney injury or expected to require renal replacement therapy within 3 months
  • BNP value of \> 200 pg/mL at OL Screening.
  • Platelet count \< 80,000 per μL at OL Screening.
  • Participants who are not receiving atrasentan at the time of substudy screening visit in the ALIGN OL extension study phase or had atrasentan interruption for longer than 2 weeks within last 24 weeks of substudy screening visit.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (135 Sites)

Showing the first 25 of 135 sites.

  • University of Alabama at Birmingham — Birmingham, Alabama
  • Comprehensive Research Institute — Alhambra, California
  • Kidney Disease Medical Group — Glendale, California
  • Stanford University — Stanford, California
  • University of Florida — Gainesville, Florida
  • GA Nephrology Associates — Lawrenceville, Georgia
  • NANI Research, LLC — Hinsdale, Illinois
  • NANI Research, LLC — Fort Wayne, Indiana
  • University of Louisville Physicians- Kidney Disease Program — Louisville, Kentucky
  • Tufts Medical Center — Boston, Massachusetts
  • Intermed Consultants — Minneapolis, Minnesota
  • Pelican Point Dialysis - DaVita Clinical Research — Las Vegas, Nevada
  • Capital District Renal Physicians — Clifton Park, New York
  • Mountain Kidney and Hypertension Associates — Asheville, North Carolina
  • Brookview Hills Research Associates, LLC — Winston-Salem, North Carolina
  • Lehigh Valley Hospital — Bethlehem, Pennsylvania
  • University of Pennsylvania — Philadelphia, Pennsylvania
  • Liberty Research Center — Dallas, Texas
  • El Paso Kidney Specialists — El Paso, Texas
  • Nephrology Associates Of Northern Virginia — Fairfax, Virginia
  • Swedish Health Services — Seattle, Washington
  • Centro Médico Ce.Re.Ca — San Luis, San Luis Province
  • CEMIC — Buenos Aires,
  • Hospital Britanico de Buenos Aires — Buenos Aires,
  • Clinica de Nefrologia Urologia y Enf. Cardiovasculares — Santa Fe,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in IgA Nephropathy

Explore by condition: All IgA Nephropathy clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗