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

Delayed Graft Function Clinical Trial

— 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

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
• Start date: February 17, 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: argenx
• Contact: Sabine Coppieters, MD
• Phone: 857-350-4834
• Email: Clinicaltrials[@]argenx.com
• Is FDA regulated: No
• 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.

Related Conditions & MeSH terms

• Delayed Graft Function

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	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 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

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