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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The change in urine protein:creatinine ratio (UPCR) from baseline to Week 12

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
Novartis Pharmaceuticals

1,375 total trials

What the registry record for NCT04573920 still lists

NCT04573920 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 5,185-participant average among 23 other Diabetic Kidney Disease trials with a reported enrollment target (98% lower).

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 names 20 study sites across 13 states, led by 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.

Learn More About Clinical Trials

Similar trials for Diabetic Kidney Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04573920's enrollment target sits among peer trials

103 12th of 23 higher than 12 of 23 other Diabetic Kidney Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetic Kidney Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04573920, the US trial registry maintained by the National Library of Medicine. NCT04573920 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.