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NCT05907096 · ClinicalTrials.gov registry record · Phase 2
ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
A Phase 2 study of Delayed Graft Function, sponsored by argenx.
- Active
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
- 20
- Study locations
NCT05907096: Active Phase 2 study of Delayed Graft Function, sponsored by argenx.
NCT05907096 is a Phase 2 study of Delayed Graft Function that is active but no longer recruiting, run by argenx. The registered enrollment target is 103 participants, below the 357-participant average among 6 other Delayed Graft Function trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05907096, a Phase 2 study of Delayed Graft Function, is active but no longer recruiting, sponsored by argenx.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 103 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main purpose of this study is to evaluate the safety, efficacy and tolerability of ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function. The study consists of 2 parts: part A comprises the main study period, and part B comprises the long-term observational follow-up period. During part A, after the screening period, eligible participants will be randomized to receive either ARGX-117 or placebo, entering the treatment and evaluation period (duration of up to 52 weeks). After the treatment period, participants will enter a follow-up period of up to 12 weeks. The total study duration varies from approximately 64 weeks up to 5 years post-transplant depending on whether a participant enrols in part B of the study.
Primary Outcome
Estimated glomerular filtration rate
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL ARGX-117
Study Locations (20)
Other
- Royal Adelaide Hospital - Adelaide
- Monash Health - Monash Medical Centre - Clayton
- Princess Alexandra Hospital - Woolloongabba
- Tirol Kliniken - A.o. Landeskrankenhaus Innsbruck - Innsbruck
- Allgemeines Krankenhaus der Stadt Wien (AKH Wien) - Vienna
- Universitair Ziekenhuis Leuven - Leuven
- Centro Hospitalar e Universitario de Coimbra - Coimbra
- Hospital Geral de Fortaleza - Fortaleza
- Santa Casa de Misericordia de Porto Alegre - Hospital Dom Vicente Scherer - Porto Alegre
- Hospital de Base - São Jose Do Rio Preto
- Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP) - São Paulo
- Hôpital Maisonneuve-Rosemont - Centre de recherche - Montreal
New York
- Erie County Medical Center - Buffalo
- Columbia University - New York
California
- Cedars-Sinai Medical Center - Los Angeles
Florida
- Tampa General Hospital - Tampa
Illinois
- University of Illinois (UI) Health - Outpatient Care Center - Chicago
New Jersey
- Cooperman Barnabas Medical Center - Livingston
Ohio
- The Ohio State University - Columbus
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2024-02-17 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 2 |
What the registry record for NCT05907096 still lists
NCT05907096 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 357-participant average among 6 other Delayed Graft Function trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Delayed Graft Function appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05907096 names 20 study sites across 8 states, led by Other, New York, California.
Frequently Asked Questions
What is clinical trial NCT05907096 about?
NCT05907096 is a clinical study titled "ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function". The main purpose of this study is to evaluate the safety, efficacy and tolerability of ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function. The study consists of 2 parts: part A comprises the main study period, and part B comprises the long-term observational ...
What is the current status of trial NCT05907096?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2024-02-17. Estimated completion is 2026-07-31.
What conditions does trial NCT05907096 study?
This clinical trial studies the following conditions: Delayed Graft Function.
What interventions are being tested in trial NCT05907096?
The interventions under investigation include: Placebo (OTHER), ARGX-117 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05907096?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05907096 being conducted?
This trial has 20 study locations across California, Florida, Illinois, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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