Determine the Safety, Tolerability, and Efficacy of MAU868 for the Prevention of BK Virus Infecti… (NCT03456999) | Clinical Trial Compass
WithdrawnPhase 2
Determine the Safety, Tolerability, and Efficacy of MAU868 for the Prevention of BK Virus Infection in Kidney Transplant Recipients
Stopped: company decision
0Started 2018-10-15
Plain-language summary
This study is being conducted to determine whether MAU868 warrants further clinical development for the prevention of BKV infection in kidney transplant recipients.
Who can participate
Age range7 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria;
* Male or female recipients of a first or second kidney or kidney-pancreas transplant who weigh at least 30 kg and are at least 7 years of age (in the US, 18 years of age or above) at the time of transplantation.
* Recipients of organs from a heart-beating deceased, non-heart-beating deceased, living unrelated, or human leukocyte antigen (HLA)-mismatched living related donor.
* Recipients who are treated with lymphocyte-depleting induction therapy (e.g., rabbit antithymocyte globulin, alemtuzumab). Subjects treated with rabbit antithymocyte globulin must receive a total dose of at least 3 mg/kg. Subjects treated with alemtuzumab must receive a total dose of at least 20 mg.
* Recipients of a kidney with a cold ischemia time (CIT) \<36 hours.
Exclusion Criteria:
* Recipients of organs from identical twins or living, HLA-matched, related donors.
* ABO incompatible or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant (isolated positive B cell crossmatches are not an exclusion criterion).
* Recipients who are treated with non-lymphocyte-depleting induction therapy (e.g., basiliximab) or no induction therapy.
* Recipients who are treated or planned to be treated with mTOR inhibitors as part of their initial immunosuppression regimen post-transplantation.
* Recipients who require antibody-depletion prior to transplantation and in the opinion of the investigator are likely to require antibody-depletion after transplantation. Antibody-dep…