Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
argenx
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Is at least the local legal age of consent for clinical studies and at least aged 18 years and less than 70 years
Agree to use contraceptive measures consistent with local regulations
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 (donation after cardiac/circulatory death) or DBD ( (donation after brain death)
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
You may not be if
Any history of prothrombotic disorder or history of thrombosis or hypercoagulable state, excluding vascular access clotting
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
High risk within the study period for recurrence of underlying renal disease in the opinion of the investigator
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
Clinically significant active bacterial, viral, or fungal infection
History of malignancy unless considered cured by adequate treatment, with no evidence of recurrence for 5 years or more before first study drug administration. 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
History of current alcohol, drug, or medication abuse as assessed by the investigator
Pregnant or lactating state or intention to become pregnant during the study
The full list of criteria can be found in the protocol.
