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NCT04573920 · ClinicalTrials.gov registry record · Phase 2

Atrasentan in Patients With Proteinuric Glomerular Diseases

A Phase 2 study of Diabetic Kidney Disease and Focal Segmental Glomerulosclerosis, sponsored by Novartis Pharmaceuticals.

Active
Registry status
Phase 2
Development phase
103
Enrollment target
20
Study locations

NCT04573920 is a Phase 2 study of Diabetic Kidney Disease and Focal Segmental Glomerulosclerosis that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 103 participants, below the 5,185-participant average among 23 other Diabetic Kidney Disease trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT04573920, a Phase 2 study of Diabetic Kidney Disease and Focal Segmental Glomerulosclerosis, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
103 participants
Enrollment target
20
Study locations

Study Summary

The AFFINITY Study is a phase 2, open-label, basket study to evaluate the efficacy and safety of atrasentan in patients with proteinuric glomerular disease who are at risk of progressive loss of renal function.

Conditions Studied

Diabetic Kidney Disease Focal Segmental Glomerulosclerosis Immunoglobulin A Nephropathy IgA Nephropathy Alport Syndrome Diabetic Nephropathy Type 2

Interventions

  • DRUG Atrasentan

Study Locations (20)

California

  • Kidney Disease Medical Group - Glendale
  • Academic Medical Research Institute - Los Angeles
  • North America Research Institute - San Dimas
  • Stanford U School Of Medicine - Stanford

Victoria

  • Novartis Investigative Site - Clayton
  • Novartis Investigative Site - Reservoir
  • Novartis Investigative Site - St Albans

North Carolina

  • Mountain Kidney And Hyper Associa - Asheville
  • Brookview Hills Research Assoc - Winston-Salem

Texas

  • Baylor Scott and White - Dallas
  • Prolato Clinical Research Center - Houston

Colorado

  • Colorado Kidney Care - Denver

Louisiana

  • Northwest Louisiana Nephrology Research - Shreveport

Massachusetts

  • Tufts Medical Center - Boston

Minnesota

  • Uni of Minnesota Hos and Clinics - Minneapolis

Trial Details

FieldValue
Enrollment Target 103 participants
Start Date 2021-03-15
Est. Completion 2026-10-27
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04573920

The ClinicalTrials.gov registry entry for NCT04573920 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,185-participant average among 23 other Diabetic Kidney Disease trials with a reported enrollment target (98% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Diabetic Kidney Disease appearing as the primary indexed condition, and to 1 intervention - of which Atrasentan is the first listed.

NCT04573920 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Victoria, North Carolina.

Frequently Asked Questions

What is clinical trial NCT04573920 about?

NCT04573920 is a clinical study titled "Atrasentan in Patients With Proteinuric Glomerular Diseases". The AFFINITY Study is a phase 2, open-label, basket study to evaluate the efficacy and safety of atrasentan in patients with proteinuric glomerular disease who are at risk of progressive loss of renal function.

What is the current status of trial NCT04573920?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2021-03-15. Estimated completion is 2026-10-27.

What conditions does trial NCT04573920 study?

This clinical trial studies the following conditions: Diabetic Kidney Disease, Focal Segmental Glomerulosclerosis, Immunoglobulin A Nephropathy, IgA Nephropathy, Alport Syndrome.

What interventions are being tested in trial NCT04573920?

The interventions under investigation include: Atrasentan (DRUG).

Who is sponsoring clinical trial NCT04573920?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04573920 being conducted?

This trial has 20 study locations across California, Colorado, Louisiana, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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