A Phase 2 interventional study of ARGX-117 and Placebo in Delayed Graft Function, sponsored by argenx. Active, not recruiting at 45 sites in 11 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by argenx · Phase 2, Interventional, and Treatment
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.
83 studies on the registry are indexed under Delayed Graft Function; 15 are open to participants now.
This study's enrollment of 103 is above the median of 90 across 62 interventional studies indexed under Delayed Graft Function.
Browse Delayed Graft Function studies →argenx is the lead sponsor of 87 studies on the registry; 29 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 16 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The full list of criteria can be found in the protocol.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receiving ARGX-117 intravenous infusions
Biological: ARGX-117
Patients receiving placebo intravenous infusions
Other: Placebo
Intravenous administration of ARGX-117
Intravenous administration of placebo
eGFR at 24 weeks posttransplant
Estimated glomerular filtration rate
Time frame: Up to 24 weeks
Proportion of participants with Delayed Graft Function (DGF)
Time frame: Up to 52 weeks
Proportion of participants with fDGF
Functional Delayed Graft Function
Time frame: Up to 52 weeks
Duration of dialysis treatment for DGF within the first 30 days posttransplant
Time frame: up to 30 days
Proportion of participants who have ongoing dialysis requirement at study day 31
Time frame: Up to 31 days
CRR at 72 hours posttransplant and on study day 8
Creatinine reduction ratio
Time frame: up to 8 days
iBox score at 52 weeks posttransplant
Time frame: up to 52 weeks
Dialysis-free participant survival through 52 weeks posttransplant
Time frame: up to 52 weeks
(Death-censored) allograft survival through 52 weeks posttransplant
Time frame: Up to 52 weeks
eGFR at 52 weeks posttransplant
Estimated glomerular filtration rate
Time frame: up to 52 weeks
Incidence of PNF
Primary Nonfunction
Time frame: up to 12 weeks
Serum concentrations for ARGX 117
Time frame: up to 64 weeks
Changes from baseline in free C2, total C2, and CH50
Time frame: up to 64 weeks
Incidence of anti-drug antibodies (ADA) against ARGX-117
Time frame: up to 64 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Feb 2024 to primary completion in Oct 2025, 19 months.
Completion moved once since we started tracking on Sep 25, 2026: Jul 2026 → May 2030, on Sep 25, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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