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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: Completed Phase 3 study of Kidney Transplantation in Highly Sensitized Patients, sponsored by Hansa Biopharma AB.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
eGFR is a measure of kidney function and will be compared between treatment arms. eGFR will be calculated based on p-creatinine according to the modification of diet in renal disease (MDRD) equation. eGFR for a kidney with normal function is 90 mL/min/1.73m2. Kidney disease is characterised by a decreased eGFR value. For randomized patients who do not undergo transplantation, lose their graft or die before 12 months, eGFR will be set to zero, consistent with kidney failure.
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 |
What the finished NCT04935177 record still lists
NCT04935177 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
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Where NCT04935177's enrollment target sits among peer trials
64 1799th of 2000 higher than 201 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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