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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05907096




Registration number
NCT05907096
Ethics application status
Date submitted
8/06/2023
Date registered
18/06/2023

Titles & IDs
Public title
ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
Scientific 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
Secondary ID [1] 0 0
2022-503091-89-00
Secondary ID [2] 0 0
ARGX-117-2201
Universal Trial Number (UTN)
Trial acronym
VARVARA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delayed Graft Function 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - ARGX-117
Other interventions - Placebo

Experimental: ARGX-117 - Patients receiving ARGX-117 intravenous infusions

Placebo comparator: Placebo - Patients receiving placebo intravenous infusions


Treatment: Other: ARGX-117
Intravenous administration of ARGX-117

Other interventions: Placebo
Intravenous administration of placebo
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
eGFR at 24 weeks posttransplant
Timepoint [1] 0 0
Up to 24 weeks
Secondary outcome [1] 0 0
Proportion of participants with Delayed Graft Function (DGF)
Timepoint [1] 0 0
Up to 52 weeks
Secondary outcome [2] 0 0
Duration of dialysis treatment for DGF within the first 30 days posttransplant (ie, date of last dialysis treatment)
Timepoint [2] 0 0
up to 30 days
Secondary outcome [3] 0 0
CRR at 72 hours and on study day 8 (posttransplant day 7)
Timepoint [3] 0 0
up to 7 days
Secondary outcome [4] 0 0
iBox score at 52 weeks posttransplant
Timepoint [4] 0 0
up to 52 weeks
Secondary outcome [5] 0 0
Dialysis-free survival through 52 weeks posttransplant
Timepoint [5] 0 0
up to 52 weeks
Secondary outcome [6] 0 0
eGFR at 52 weeks posttransplant
Timepoint [6] 0 0
up to 52 weeks
Secondary outcome [7] 0 0
Incidence of PNF (Primary Nonfunction)
Timepoint [7] 0 0
up to 52 weeks
Secondary outcome [8] 0 0
Serum concentrations for ARGX 117
Timepoint [8] 0 0
up to 52 weeks
Secondary outcome [9] 0 0
Values from baseline in free C2, total C2, and CH50 activity
Timepoint [9] 0 0
up to 52 weeks
Secondary outcome [10] 0 0
Change from baseline in free C2, total C2, and CH50 activity
Timepoint [10] 0 0
up to 52 weeks
Secondary outcome [11] 0 0
Incidence of ADA against ARGX-117
Timepoint [11] 0 0
up to 52 weeks
Secondary outcome [12] 0 0
Prevalence of ADA against ARGX-117
Timepoint [12] 0 0
Up to 52 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Monash Health - Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
SA 5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
QLD 4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
Canada
State/province [3] 0 0
Montréal
Country [4] 0 0
Canada
State/province [4] 0 0
Vancouver
Country [5] 0 0
France
State/province [5] 0 0
Bordeaux
Country [6] 0 0
Italy
State/province [6] 0 0
Bologna
Country [7] 0 0
Italy
State/province [7] 0 0
Torino
Country [8] 0 0
Portugal
State/province [8] 0 0
Carnaxide
Country [9] 0 0
Portugal
State/province [9] 0 0
Lisboa
Country [10] 0 0
Portugal
State/province [10] 0 0
Porto
Country [11] 0 0
Spain
State/province [11] 0 0
Badalona
Country [12] 0 0
Spain
State/province [12] 0 0
Barcelona
Country [13] 0 0
Spain
State/province [13] 0 0
Granada
Country [14] 0 0
Spain
State/province [14] 0 0
L'Hospitalet De Llobregat
Country [15] 0 0
Spain
State/province [15] 0 0
Valencia
Country [16] 0 0
Spain
State/province [16] 0 0
Zaragoza

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
argenx
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sabine Coppieters, MD
Address 0 0
Country 0 0
Phone 0 0
857-350-4834
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05907096