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ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
NCT05907096 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05907096
The ClinicalTrials.gov registry entry for NCT05907096 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is argenx, which has 96 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05907096 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, New York, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05907096?
The interventions under investigation include: Placebo (OTHER), ARGX-117 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05907096?
This trial is sponsored by argenx, which has 96 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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