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NCT02790437 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study to Evaluate the Efficacy of IdeS to Desensitize Transplant Patients With a Positive Crossmatch Test
A Phase 2 study of Kidney Failure, Chronic, sponsored by Hansa Biopharma AB.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
- 5
- Study locations
NCT02790437: Completed Phase 2 study of Kidney Failure, Chronic, sponsored by Hansa Biopharma AB.
NCT02790437 is a Phase 2 study of Kidney Failure, Chronic that has completed, run by Hansa Biopharma AB. The registered enrollment target is 19 participants, below the 331-participant average among 23 other Kidney Failure, Chronic trials with a reported enrollment target (94% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02790437, a Phase 2 study of Kidney Failure, Chronic, has completed, sponsored by Hansa Biopharma AB.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to evaluate the effectiveness of the study drug IdeS in patients who are on the waiting list for kidney transplant and have previously undergone desensitization unsuccessfully or in whom effective desensitization will be highly unlikely. At study entry, the patients will have an available deceased or live donor with a positive crossmatch test. The study will assess IdeS efficacy and safety in removing Donor Specific Antibodies (DSAs) and thereby convert a positive crossmatch test to negative.
Primary Outcome
IdeS ability to create a negative crossmatch (XM) test in patients who before treatment exhibit Donor Specific Antibodies (DSAs) and have a positive XM test to their available live or deceased donor kidney. XM was assessed using both FACS and CDC XM tests. FACS XM is a multi-staining procedure where the recipient's serum is used to stain donor cells to identify presence of DSAs in recipient's serum. T- and B-cells are identified using conjugated antibodies against CD3 and CD19. DSAs are identif
Conditions Studied
Interventions
- DRUG IdeS
- PROCEDURE Kidney transplantation
Study Locations (5)
Other
- Necker Hospital - Paris
- Uppsala University Hospital - Uppsala
California
- Cedars-Sinai Medical Center - Los Angeles
Maryland
- The Johns Hopkins Hospital - Baltimore
New York
- New York University School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2016-06 |
| Est. Completion | 2018-07-03 |
| Phase | Phase 2 |
What the finished NCT02790437 record still lists
NCT02790437 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 331-participant average among 23 other Kidney Failure, Chronic trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Kidney Failure, Chronic appearing as the primary indexed condition, and to 2 interventions - of which IdeS is the first listed.
NCT02790437 lists 5 locations in 4 states (Other, California, Maryland).
Frequently Asked Questions
What is clinical trial NCT02790437 about?
NCT02790437 is a clinical study titled "A Phase II Study to Evaluate the Efficacy of IdeS to Desensitize Transplant Patients With a Positive Crossmatch Test". The purpose of this study is to evaluate the effectiveness of the study drug IdeS in patients who are on the waiting list for kidney transplant and have previously undergone desensitization unsuccessfully or in whom effective desensitization will be highly unlikely. At study entry, the patients will...
What is the current status of trial NCT02790437?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2016-06. Estimated completion is 2018-07-03.
What conditions does trial NCT02790437 study?
This clinical trial studies the following conditions: Kidney Failure, Chronic.
What interventions are being tested in trial NCT02790437?
The interventions under investigation include: IdeS (DRUG), Kidney transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT02790437?
This trial is sponsored by Hansa Biopharma AB, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02790437 being conducted?
This trial has 5 study locations across California, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT02790437's enrollment target sits among peer trials
19 22nd of 23 higher than 2 of 23 other Kidney Failure, Chronic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Failure, Chronic 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.
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