VARVARA: ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
Study Details
Study Description
Brief Summary
This is a phase 2 study to evaluate the safety, efficacy and tolerability of ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ARGX-117 Patients receiving ARGX-117 intravenous infusions |
Biological: ARGX-117
Intravenous administration of ARGX-117
|
| Placebo Comparator: Placebo Patients receiving placebo intravenous infusions |
Other: Placebo
Intravenous administration of placebo
|
Outcome Measures
Primary Outcome Measures
- eGFR at 24 weeks posttransplant [Up to 24 weeks]
Estimated glomerular filtration rate
Secondary Outcome Measures
- Proportion of participants with Delayed Graft Function (DGF) [Up to 52 weeks]
- Duration of dialysis treatment for DGF within the first 30 days posttransplant (ie, date of last dialysis treatment) [up to 30 days]
- CRR at 72 hours and on study day 8 (posttransplant day 7) [up to 7 days]
Creatinine reduction ratio
- iBox score at 52 weeks posttransplant [up to 52 weeks]
- Dialysis-free survival through 52 weeks posttransplant [up to 52 weeks]
- eGFR at 52 weeks posttransplant [up to 52 weeks]
Estimated glomerular filtration rate
- Incidence of PNF (Primary Nonfunction) [up to 52 weeks]
- Serum concentrations for ARGX 117 [up to 52 weeks]
- Values from baseline in free C2, total C2, and CH50 activity [up to 52 weeks]
- Change from baseline in free C2, total C2, and CH50 activity [up to 52 weeks]
- Incidence of ADA against ARGX-117 [up to 52 weeks]
- Prevalence of ADA against ARGX-117 [Up to 52 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Is at least the local legal age of consent for clinical 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
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Agree to use contraceptive measures consistent with local regulations
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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 dialysis for at least 3 months
-
Are recipients of de novo or second-time, single kidney transplant from a deceased donor, either DCD or DBD
-
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
-
Have received SARS-CoV-2 vaccinations consistent with participating site's requirements
Exclusion Criteria:
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Any known history of complement deficiency
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Evidence of peritonitis in participants on peritoneal dialysis
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Received any solid organ, bone marrow, or hematopoietic stem cell transplant, with the exception of prior first kidney transplant
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Current treatment for an autoimmune disease requiring maintenance immunosuppression to control systemic disease activity that would pose a significant safety risk or put the participant at undue harm in the opinion of the investigator
-
Any history of malignancy unless considered cured by adequate treatment with no evidence of recurrence for more than 5 years before the first administration of IMP. 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
-
Unwillingness to receive vaccinations consistent with protocol-mandated and participating site requirements
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Clinically significant active bacterial, viral, or fungal infection or infection with HBV, HCV, HIV or tuberculosis.
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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
-
Received a different IMP in another clinical study less than 12 weeks or 5 half-lives (whichever is longer) before screening
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Currently participating in another interventional clinical study or previously participated in an ARGX-117 clinical study and received at least 1 dose of IMP
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Known hypersensitivity to ARGX-117 or any of its excipients or to tacrolimus, MMF or mycophenolic acid, or antithymocyte globulin or allergy to Leporidae (eg, rabbit)
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History (within 12 months before screening) of current alcohol, drug, or medication abuse as assessed by the investigator
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Pregnant or lactating state or intention to become pregnant during the study
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Received any prior desensitization therapies or any pretransplant immunosuppressive therapy within 5 half-lives or twice the duration of the biological effect, whichever is longer.
The full list is available in the protocol.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- argenx
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ARGX-117-2201