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NCT04935177 · ClinicalTrials.gov registry record · Phase 3
Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx
A Phase 3 study of Kidney Transplantation in Highly Sensitized Patients, sponsored by Hansa Biopharma AB.
- Completed
- Registry status
- Phase 3
- Development phase
- 64
- Enrollment target
- 20
- Study locations
NCT04935177 is a Phase 3 study of Kidney Transplantation in Highly Sensitized Patients that has completed, run by Hansa Biopharma AB. The registered enrollment target is 64 participants. The trial reports 20 study locations across 12 states.
The verdict
NCT04935177, a Phase 3 study of Kidney Transplantation in Highly Sensitized Patients, has completed, sponsored by Hansa Biopharma AB.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 64 participants
- Enrollment target
- 20
- Study locations
Study Summary
An open-label, controlled, randomized Phase 3 trial evaluating 12-month kidney function in highly sensitized (cPRA ≥99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with standard of care
Conditions Studied
Interventions
- DRUG Eculizumab
- DRUG IVIg
- DRUG Imlifidase
- PROCEDURE PLEX
- DRUG Anti-CD20 antibodies
Study Locations (20)
California
- Keck Hospital of University of Southern California (USC) - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
- Sutter Health - California Pacific Medical Center - San Francisco
- University of California San Francisco (UCSF) Medical Center - San Francisco
New York
- New York University (NYU) Langone Transplant Institute, NYU Langone Health - New York
- Columbia University - New York
- New York-Presbyterian - Weill Cornell Medical Center - New York
Arizona
- Banner Health - University Medical Center - Phoenix - Phoenix
- Mayo Clinic Phoenix - Phoenix
Illinois
- Northwestern University - Chicago
- University of Chicago Medical Center - Chicago
Minnesota
- University of Minnesota Medical School - Minneapolis
- Mayo Clinic Rochester - Rochester
Alabama
- University of Alabama at Birmingham (UAB) Hospital - Birmingham
District of Columbia
- Georgetown Transplant Institute - Washington D.C.
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2021-10-14 |
| Est. Completion | 2025-06-20 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04935177
The ClinicalTrials.gov registry entry for NCT04935177 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hansa Biopharma AB, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Kidney Transplantation in Highly Sensitized Patients appearing as the primary indexed condition, and to 5 interventions - of which Eculizumab is the first listed.
NCT04935177 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, New York, Arizona.
Frequently Asked Questions
What is clinical trial NCT04935177 about?
NCT04935177 is a clinical study titled "Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx". An open-label, controlled, randomized Phase 3 trial evaluating 12-month kidney function in highly sensitized (cPRA ≥99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with standard of care
What is the current status of trial NCT04935177?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 64 participants. The study started on 2021-10-14. Estimated completion is 2025-06-20.
What conditions does trial NCT04935177 study?
This clinical trial studies the following conditions: Kidney Transplantation in Highly Sensitized Patients.
What interventions are being tested in trial NCT04935177?
The interventions under investigation include: Eculizumab (DRUG), IVIg (DRUG), Imlifidase (DRUG), PLEX (PROCEDURE), Anti-CD20 antibodies (DRUG).
Who is sponsoring clinical trial NCT04935177?
This trial is sponsored by Hansa Biopharma AB, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04935177 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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