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ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function

Study acronym: VARVARA
StatusActive, Not Recruiting
PhasePhase 2
Sponsorargenx
Started2024-02-17
View on ClinicalTrials.gov ↗

Amendment history

2026-09-26
Completion pushed: 2026-07-31 → 2030-05
2026-03-16
Study Status, Oversight v12
Primary completion dateestimated 2025-11→confirmed 2025-10-16
2025-06-17
Recruiting→Active, Not Recruiting Study Status, Study Design, Outcome Measures, Contacts/Locations v11
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2026-04→2025-11
Completion date2026-12→2026-07-31
Enrollment targetestimated 102→confirmed 103
Secondary endpoints13 entries, revised
Proportion of participants with fDGF (functional delayed graft function) Incidence of Primary Nonfunction (PNF) ValuesChanges from baseline in free C2, total C2, and CH50
Study sitesdetails revised at 45 of 45 sites
2025-03-26
Study Identification, Study Status, Contacts/Locations v10
Study sites43→45
Study titlerevised
ARGX-117 in Deceased Donor Kidney Transplant Recipients Atat Risk for Delayed Graft Function
2025-01-13
Study Status, Contacts/Locations v9
Study sites40→43
Show 8 earlier versions
2024-11-25
Study Status, Contacts/Locations v8
Study sites34→40
2024-10-23
Study Identification, Study Status, Oversight, Study Description, Outcome Measures, Eligibility, Contacts/Locations v7
Study sites23→34
Eligibility criteria-1,030 characters
[...] al studies and at least aged 18 years and less than 70 years when signing the ICF Is capable of providing signed informed consent and complying with protocol requirements Agree to use contraceptive measures consistent with local regulations Have dry body weight less than 120 kg and body mass index less than 40 kg/m2 at screening Are diagnosed with ESRD and have been stable on chronic dial [...] single kidney transplant from a deceased donor, either DCD (donation after cardiac/circulatory death) or DBD ( (donation after brain death) Are ABO compatible with donor allograft, except for type A2 [...] the vacci [...]
Secondary endpoints12 to 13 entries
Proportion of participants with fDGF (functional delayed graft function) Duration of dialysis treatment for DGF within the first 30 days posttransplant (ie, date Proportion of lastparticipants who have ongoing dialysis treatment)requirement at study day 31 CRR at 72 hours posttransplant and on study day 8 (posttransplant day 7) Dialysis-free participant survival through 52 weeks posttransplant (Death-censored) allograft survival through 52 weeks posttransplant Incidence of PNF (Primary Nonfunction (PNF) Values from baseline in free C2, total C2, and CH50 activity Change from baseline in free C [...] [...]
Study titlerevised
ARGX-117 in Deceased Donor Kidney Transplant Recipients atAt Risk for Delayed Graft Function
2024-08-14
Study Status, Contacts/Locations v6
Study sites19→23
2024-07-15
Study Status, Contacts/Locations v5
Study sites16→19
2024-06-14
Study Status, Contacts/Locations v4
Study sites12→16
2024-05-06
Study Status, Contacts/Locations v3
Study sites6→12
2024-03-05
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-02→confirmed 2024-02-17
Study sites0→6
2024-02-06
Study Status v1
Start date2023-10→2024-02
2023-06-08
Original filing
Argenx
56 trials monitored
See 2 trials at risk
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.
Trial Details
NCT Number NCT05907096
Lead Sponsor argenx
Conditions Delayed Graft Function
Enrollment 103 participants
Start Date 2024-02-17
Primary Completion 2025-10-16 (estimated)
Study Completion 2030-05 (estimated)
Updated on ClinicalTrials.gov 2026-09-25