search
Back to results

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

Primary Purpose

Delayed Graft Function

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ARGX-117
Placebo
Sponsored by
argenx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delayed Graft Function

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 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: 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 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 Clinically significant active bacterial, viral, or fungal infection or infection with HBV, HCV, HIV or tuberculosis. 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 Currently participating in another interventional clinical study or previously participated in an ARGX-117 clinical study and received at least 1 dose of IMP 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) History (within 12 months before screening) of current alcohol, drug, or medication abuse as assessed by the investigator Pregnant or lactating state or intention to become pregnant during the study 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    ARGX-117

    Placebo

    Arm Description

    Patients receiving ARGX-117 intravenous infusions

    Patients receiving placebo intravenous infusions

    Outcomes

    Primary Outcome Measures

    eGFR at 24 weeks posttransplant
    Estimated glomerular filtration rate

    Secondary Outcome Measures

    Proportion of participants with Delayed Graft Function (DGF)
    Duration of dialysis treatment for DGF within the first 30 days posttransplant (ie, date of last dialysis treatment)
    CRR at 72 hours and on study day 8 (posttransplant day 7)
    Creatinine reduction ratio
    iBox score at 52 weeks posttransplant
    Dialysis-free survival through 52 weeks posttransplant
    eGFR at 52 weeks posttransplant
    Estimated glomerular filtration rate
    Incidence of PNF (Primary Nonfunction)
    Serum concentrations for ARGX 117
    Values from baseline in free C2, total C2, and CH50 activity
    Change from baseline in free C2, total C2, and CH50 activity
    Incidence of ADA against ARGX-117
    Prevalence of ADA against ARGX-117

    Full Information

    First Posted
    June 8, 2023
    Last Updated
    June 8, 2023
    Sponsor
    argenx
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05907096
    Brief Title
    ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
    Acronym
    VARVARA
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    April 2026 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    argenx

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Delayed Graft Function

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    102 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ARGX-117
    Arm Type
    Experimental
    Arm Description
    Patients receiving ARGX-117 intravenous infusions
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Patients receiving placebo intravenous infusions
    Intervention Type
    Biological
    Intervention Name(s)
    ARGX-117
    Intervention Description
    Intravenous administration of ARGX-117
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Intravenous administration of placebo
    Primary Outcome Measure Information:
    Title
    eGFR at 24 weeks posttransplant
    Description
    Estimated glomerular filtration rate
    Time Frame
    Up to 24 weeks
    Secondary Outcome Measure Information:
    Title
    Proportion of participants with Delayed Graft Function (DGF)
    Time Frame
    Up to 52 weeks
    Title
    Duration of dialysis treatment for DGF within the first 30 days posttransplant (ie, date of last dialysis treatment)
    Time Frame
    up to 30 days
    Title
    CRR at 72 hours and on study day 8 (posttransplant day 7)
    Description
    Creatinine reduction ratio
    Time Frame
    up to 7 days
    Title
    iBox score at 52 weeks posttransplant
    Time Frame
    up to 52 weeks
    Title
    Dialysis-free survival through 52 weeks posttransplant
    Time Frame
    up to 52 weeks
    Title
    eGFR at 52 weeks posttransplant
    Description
    Estimated glomerular filtration rate
    Time Frame
    up to 52 weeks
    Title
    Incidence of PNF (Primary Nonfunction)
    Time Frame
    up to 52 weeks
    Title
    Serum concentrations for ARGX 117
    Time Frame
    up to 52 weeks
    Title
    Values from baseline in free C2, total C2, and CH50 activity
    Time Frame
    up to 52 weeks
    Title
    Change from baseline in free C2, total C2, and CH50 activity
    Time Frame
    up to 52 weeks
    Title
    Incidence of ADA against ARGX-117
    Time Frame
    up to 52 weeks
    Title
    Prevalence of ADA against ARGX-117
    Time Frame
    Up to 52 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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 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 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: 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 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 Clinically significant active bacterial, viral, or fungal infection or infection with HBV, HCV, HIV or tuberculosis. 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 Currently participating in another interventional clinical study or previously participated in an ARGX-117 clinical study and received at least 1 dose of IMP 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) History (within 12 months before screening) of current alcohol, drug, or medication abuse as assessed by the investigator Pregnant or lactating state or intention to become pregnant during the study 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sabine Coppieters, MD
    Phone
    857-350-4834
    Email
    Clinicaltrials@argenx.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs