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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05907096
Other study ID # ARGX-117-2201
Secondary ID 2022-503091-89-0
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 17, 2024
Est. completion date December 2026

Study information

Verified date June 2024
Source argenx
Contact Sabine Coppieters, MD
Phone 857-350-4834
Email Clinicaltrials@argenx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 102
Est. completion date December 2026
Est. primary completion date April 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
ARGX-117
Intravenous administration of ARGX-117
Other:
Placebo
Intravenous administration of placebo

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide
Australia Monash Health - Monash Medical Centre Clayton
Australia Princess Alexandra Hospital Woolloongabba
Belgium Universitair Ziekenhuis Leuven Leuven
Canada Hôpital Maisonneuve-Rosemont - Centre de recherche Montréal
France CHU Bordeaux - Groupe Hospitalier Pellegrin Bordeaux
Portugal Centro Hospitalar de Lisboa Ocidental EPE - Hospital de Santa Cruz Carnaxide
Portugal Centro Hospitalar Universitario de Santo Antonio Porto
Spain Hospital Universitari Germans Trias i Pujol (HUGTP) Badalona
Spain Fundacio Puigvert Barcelona
Spain Hospital del Mar Barcelona
Spain Hospital Universitario Vall d'Hebron Barcelona
Spain Hospital Universitario Virgen de las Nieves - Hospital General Granada
Spain Hospital Universitari de Bellvitge L'Hospitalet De Llobregat
Spain Hospital Universitari Doctor Peset Valencia
Spain Hospital Universitario Miguel Servet Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
argenx

Countries where clinical trial is conducted

Australia,  Belgium,  Canada,  France,  Portugal,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary eGFR at 24 weeks posttransplant Estimated glomerular filtration rate Up to 24 weeks
Secondary Proportion of participants with Delayed Graft Function (DGF) Up to 52 weeks
Secondary Duration of dialysis treatment for DGF within the first 30 days posttransplant (ie, date of last dialysis treatment) up to 30 days
Secondary CRR at 72 hours and on study day 8 (posttransplant day 7) Creatinine reduction ratio up to 7 days
Secondary iBox score at 52 weeks posttransplant up to 52 weeks
Secondary Dialysis-free survival through 52 weeks posttransplant up to 52 weeks
Secondary eGFR at 52 weeks posttransplant Estimated glomerular filtration rate up to 52 weeks
Secondary Incidence of PNF (Primary Nonfunction) up to 52 weeks
Secondary Serum concentrations for ARGX 117 up to 52 weeks
Secondary Values from baseline in free C2, total C2, and CH50 activity up to 52 weeks
Secondary Change from baseline in free C2, total C2, and CH50 activity up to 52 weeks
Secondary Incidence of ADA against ARGX-117 up to 52 weeks
Secondary Prevalence of ADA against ARGX-117 Up to 52 weeks
See also
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