Delayed Graft FunctionPhase 2VARVARANCT05907096
ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
A Phase 2 study testing ARGX-117 in people with Delayed Graft Function, run by argenx at 45 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Delayed Graft Function
- What is being tested?
- ARGX-117
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 45 sitesin 11 countries
- Study dates
- 17 Feb 2024to May 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is at least the local legal age of consent for clinical studies and at least aged 18 years and less than 70 years
- Agree to use contraceptive measures consistent with local regulations
- Are diagnosed with ESRD and have been stable on chronic dialysis for at least 3 months
- Are recipients of de novo or second-time, 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 donor to type B recipient kidneys
- Have a negative cross match
- Have received pretransplant vaccinations for: Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae, or are willing to receive the vaccinations approximately 3 to 4 months posttransplant
Who cannot join
- Any history of prothrombotic disorder or history of thrombosis or hypercoagulable state, excluding vascular access clotting
- Any known history of complement deficiency
- Evidence of peritonitis in participants on peritoneal dialysis
- Received any solid organ, bone marrow, or hematopoietic stem cell transplant, with the exception of prior first kidney transplant
- High risk within the study period for recurrence of underlying renal disease in the opinion of the investigator
- Clinically significant comorbidity, recent major surgery (within 3 months of screening), history of any treatment nonadherence, or intention to have surgery during the study other than kidney transplantation; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
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- Clinically significant active bacterial, viral, or fungal infection
- History of malignancy unless considered cured by adequate treatment, with no evidence of recurrence for 5 years or more before first study drug administration. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer
- History of current alcohol, drug, or medication abuse as assessed by the investigator
- Pregnant or lactating state or intention to become pregnant during the study
- The full list of criteria can be found in the protocol.
Trial locations and contacts
45 sites in 11 countries.
45 sites in 11 countries
United States8 sites
Erie County Medical Center
Buffalo, New York, 14215
University of Illinois (UI) Health - Outpatient Care Center
Chicago, Illinois, 60612
The Ohio State University
Columbus, Ohio, 43210
University of Texas Southwestern Medical Center
Dallas, Texas, 10267
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Columbia University
New York, New York, 10032
Tampa General Hospital
Tampa, Florida, 33606
Spain8 sites
Hospital Universitari Germans Trias i Pujol (HUGTP)
Badalona, 08916
Hospital del Mar
Barcelona, 08003
Fundacio Puigvert
Barcelona, 08025
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital Universitario Virgen de las Nieves - Hospital General
Granada, 18014
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, 08907
Hospital Universitari Doctor Peset
Valencia, 46017
Hospital Universitario Miguel Servet
Zaragoza, 50009
France6 sites
CHU Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, 33076
Assistance Publique Hopitaux de Paris (AP-HP) - Hopital Henri Mondor
Créteil, 94000
CHU Grenoble Alpes - Hopital Michallon
La Tronche, 38700
Assistance Publique Hopitaux de Paris (AP-HP) - Hopital Necker-Enfants Malades
Paris, 75015
CHU de Toulouse - Hopital Rangueil
Toulouse, 31400
CHRU de Tours - Hopital Bretonneau
Tours, 37000
Brazil5 sites
Centro Hospitalar e Universitario de Coimbra
Coimbra, 3004-561
Hospital Geral de Fortaleza
Fortaleza, 60156-290
Santa Casa de Misericordia de Porto Alegre - Hospital Dom Vicente Scherer
Porto Alegre, 90020-090
Hospital de Base
São Jose Do Rio Preto, 15090-000
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP)
São Paulo, 05403-000
Canada4 sites
Hôpital Maisonneuve-Rosemont - Centre de recherche
Montreal, H1T 2M4
McGill University Health Centre - Royal Victoria Hospital
Montreal, H4A 3J1
Vancouver Coastal Health - Vancouver General Hospital Diamond Healthcare Centre
Vancouver, V5Z 1M9
Providence Health Care - St. Pauls Hospital
Vancouver, V6Z 1Y6
Australia3 sites
Royal Adelaide Hospital
Adelaide, SA 5000
Monash Health - Monash Medical Centre
Clayton, 3168
Princess Alexandra Hospital
Woolloongabba, QLD 4102
Italy3 sites
Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola
Bologna, 40138
Azienda Ospedale Universita Padova
Padova, 35128
Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino - Presidio Molinette
Torino, 10126
Portugal3 sites
Centro Hospitalar de Lisboa Ocidental EPE - Hospital de Santa Cruz
Carnaxide, 2790-134
Centro Hospitalar Universitario Lisboa Central EPE - Hospital Curry Cabral
Lisbon, 1069-099
Centro Hospitalar Universitario de Santo Antonio
Porto, 4099-001
Austria2 sites
Tirol Kliniken - A.o. Landeskrankenhaus Innsbruck
Innsbruck, 6020
Allgemeines Krankenhaus der Stadt Wien (AKH Wien)
Vienna, 1090
Sweden2 sites
Sahlgrenska Universitetssjukhuset
Gothenburg, 41345
Akademiska sjukhuset
Uppsala, 75185
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Assess the Safety, Efficacy, and Tolerability of ARGX-117 in Improving Allograft Function in Recipients of a Deceased Donor Renal Allograft 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 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
- Delayed Graft Function
- Being tested
- ARGX-117, Placebo
- Medical subject headings
- Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARGX-117Biological
Intravenous administration of ARGX-117
PlaceboOther
Intravenous administration of placebo
| Study group | Role | What they receive |
|---|---|---|
| ARGX-117 | Experimental | Patients receiving ARGX-117 intravenous infusions Receives: Biological: ARGX-117 |
| Placebo | Placebo comparator | Patients receiving placebo intravenous infusions Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
eGFR at 24 weeks posttransplant
Estimated glomerular filtration rate
Measured: Up to 24 weeks
Secondary outcomes (13)
Proportion of participants with Delayed Graft Function (DGF)
Measured: Up to 52 weeks
Proportion of participants with fDGF
Functional Delayed Graft Function
Measured: Up to 52 weeks
Duration of dialysis treatment for DGF within the first 30 days posttransplant
Measured: up to 30 days
Proportion of participants who have ongoing dialysis requirement at study day 31
Measured: Up to 31 days
CRR at 72 hours posttransplant and on study day 8
Creatinine reduction ratio
Measured: up to 8 days
iBox score at 52 weeks posttransplant
Measured: up to 52 weeks
Dialysis-free participant survival through 52 weeks posttransplant
Measured: up to 52 weeks
(Death-censored) allograft survival through 52 weeks posttransplant
Measured: Up to 52 weeks
eGFR at 52 weeks posttransplant
Estimated glomerular filtration rate
Measured: up to 52 weeks
Incidence of PNF
Primary Nonfunction
Measured: up to 12 weeks
Serum concentrations for ARGX 117
Measured: up to 64 weeks
Changes from baseline in free C2, total C2, and CH50
Measured: up to 64 weeks
Incidence of anti-drug antibodies (ADA) against ARGX-117
Measured: up to 64 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start17 Feb 2024
- Primary completion16 Oct 2025
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Graft FunctionStudies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907096
- Sponsor's protocol ID
- ARGX-117-2201
- Other IDs
- 2022-503091-89-00
- Acronym
- VARVARA
- Status last verified
- Oct 2026
- First submitted
- 8 Jun 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Assess the Safety, Efficacy, and Tolerability of ARGX-117 in Improving Allograft Function in Recipients of a Deceased Donor Renal Allograft at Risk for Delayed Graft Function
- ClinicalTrials.gov ID
- NCT05907096
- Acronym / sponsor ID
- VARVARA / ARGX-117-2201
- Conditions
- Delayed Graft Function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 103 participants (actual)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2024 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- May 2030 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARGX-117 | Experimental | Biological: ARGX-117Patients receiving ARGX-117 intravenous infusions |
| Placebo | Placebo comparator | Other: PlaceboPatients receiving placebo intravenous infusions |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Is at least the local legal age of consent for clinical studies and at least aged 18 years and less than 70 years
- Agree to use contraceptive measures consistent with local regulations
- Are diagnosed with ESRD and have been stable on chronic dialysis for at least 3 months
- Are recipients of de novo or second-time, 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 donor to type B recipient kidneys
Key exclusion criteria (11 listed)
- Any history of prothrombotic disorder or history of thrombosis or hypercoagulable state, excluding vascular access clotting
- Any known history of complement deficiency
- Evidence of peritonitis in participants on peritoneal dialysis
- Received any solid organ, bone marrow, or hematopoietic stem cell transplant, with the exception of prior first kidney transplant
- High risk within the study period for recurrence of underlying renal disease in the opinion of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARGX-117Intravenous administration of ARGX-117 | Biological | ARGX-117 |
| PlaceboIntravenous administration of placebo | Other | Placebo |
Primary outcome
eGFR at 24 weeks posttransplant
Time frame: Up to 24 weeks
Estimated glomerular filtration rate
13 secondary outcomes
Proportion of participants with Delayed Graft Function (DGF)
Time frame: Up to 52 weeks
Proportion of participants with fDGF
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
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
Time frame: up to 52 weeks
Incidence of PNF
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Drone Transport of Deceased-Donor Kidney Grafts Between Two French Hospitals Before Transplantation: a Pilot Safety Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
45 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARGX-117 in people with Delayed Graft Function, run by argenx at 45 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Spain, France, Brazil, Canada and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eGFR at 24 weeks posttransplant (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.