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NCT04053764 · ClinicalTrials.gov registry record · Phase 2

Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease

A Phase 2 study of Sickle Cell Disease (SCD), sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
58
Enrollment target
20
Study locations

NCT04053764: Completed Phase 2 study of Sickle Cell Disease (SCD), sponsored by Novartis Pharmaceuticals.

NCT04053764 is a Phase 2 study of Sickle Cell Disease (SCD) that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 58 participants, below the 400-participant average among 4 other Sickle Cell Disease (SCD) trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04053764, a Phase 2 study of Sickle Cell Disease (SCD), has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
58 participants
Enrollment target
20
Study locations

Study Summary

The goal of the study was to evaluate descriptively the effect of crizanlizumab + standard of care and standard of care alone on renal function in sickle cell disease patients ≥ 16 years with chronic kidney disease due to sickle cell nephropathy.

Primary Outcome

The effect of SEG101 on clinical disease activity was measured by at least 30% decrease in Albumin to Creatinine Ratio (ACR) from baseline to month 12. A reduction from baseline indicates improvement in patients.

Conditions Studied

Sickle Cell Disease (SCD)

Interventions

  • DRUG Standard of Care
  • DRUG Crizanlizuamb

Study Locations (20)

Other

  • Novartis Investigative Site - Porto Alegre
  • Novartis Investigative Site - Créteil
  • Novartis Investigative Site - Paris
  • Novartis Investigative Site - Athens
  • Novartis Investigative Site - Larissa
  • Novartis Investigative Site - Dublin
  • Novartis Investigative Site - Tripoli
  • Novartis Investigative Site - Amsterdam
  • Novartis Investigative Site - Panama City
  • Novartis Investigative Site - Adana
  • Novartis Investigative Site - Adana

Alabama

  • University of Alabama Birmingham - Birmingham

Illinois

  • University of Illinois Hospital and Health Sciences System . - Chicago

Louisiana

  • Our Lady of the Lake Regional Medic . - Baton Rouge

North Carolina

  • East Carolina University BrodySchool of Med 3 - Greenville

Tennessee

  • Univ of Tenn Health Sciences Ctr - Memphis

Texas

  • University of Texas Health Science Center at Houston - Houston

Rio de Janeiro

  • Novartis Investigative Site - Rio de Janeiro

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2019-12-10
Est. Completion 2023-03-20
Phase Phase 2
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT04053764 record still lists

NCT04053764 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 400-participant average among 4 other Sickle Cell Disease (SCD) trials with a reported enrollment target (85% lower).

The record links to 1 condition, with Sickle Cell Disease (SCD) appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.

NCT04053764 names 20 study sites across 10 states, led by Other, Alabama, Illinois.

Frequently Asked Questions

What is clinical trial NCT04053764 about?

NCT04053764 is a clinical study titled "Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease". The goal of the study was to evaluate descriptively the effect of crizanlizumab + standard of care and standard of care alone on renal function in sickle cell disease patients ≥ 16 years with chronic kidney disease due to sickle cell nephropathy.

What is the current status of trial NCT04053764?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2019-12-10. Estimated completion is 2023-03-20.

What conditions does trial NCT04053764 study?

This clinical trial studies the following conditions: Sickle Cell Disease (SCD).

What interventions are being tested in trial NCT04053764?

The interventions under investigation include: Standard of Care (DRUG), Crizanlizuamb (DRUG).

Who is sponsoring clinical trial NCT04053764?

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

Where is trial NCT04053764 being conducted?

This trial has 20 study locations across Alabama, Illinois, Louisiana, North Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT04053764, the US trial registry maintained by the National Library of Medicine. NCT04053764 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.