Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participant is scheduled to receive a primary or secondary renal allograft from a donor
Participant is seronegative for CMV and is receiving an allograft from a CMV-seropositive donor
Female participants of child-bearing age must have a negative pregnancy test result on Day 1, prior to infusion
For women who are not postmenopausal or surgically sterile (defined as absence of ovaries and/or uterus): agreement to remain completely abstinent or use two methods of contraception at all times
You may not be if
Participant is suspected of having CMV disease
Participant has received anti-CMV therapy within the 30 days prior to screening (exceptions are the use of acyclovir, valacyclovir, or famciclovir for up to 10 days duration for treatment of acute herpes simplex or herpes zoster or participants receiving acyclovir or valacyclovir at doses to suppress herpes zoster)
Participants who have received intravenous immunoglobulin (IVIG) within 3 months before transplantation or with expectation of receiving IVIG at time of transplantation or in the 3 months after transplantation
Participants who have received B cell-depleting therapies (including but not limited to rituximab) within 3 months before transplantation or with the expectation of receiving such therapy at the time of transplantation or in the 3 months after transplantation
Participant is receiving a multi-organ transplant (e.g., liver or pancreas in addition to kidney)
Active or chronic hepatic or hepatobiliary disease (including known Gilbert's syndrome) or elevations in a hepatic transaminase or bilirubin \>= 2 times upper limits of normal (ULN)
Participant is unlikely or unwilling to be available for follow-up for the full 24-week duration of the study
Female participants who are pregnant, plan to become pregnant during the study, or who are breastfeeding
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins or human-derived immunoglobulin preparations; or any constituent of MCMV5322A/MCMV3068A or placebo
Active treatment for untreated tuberculosis or other infectious conditions that are significant in the judgment of the investigator
Infection with hepatitis B, hepatitis C or human immunodeficiency virus
Previous exposure to any investigational agent within 12 weeks or 5 half-lives
Any other acute or chronic condition, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the Principal Investigator, contraindicates the use of an investigational drug or that may affect the interpretation of the results or that renders the participant at high risk for treatment complications
History of alcoholism or substance abuse within 6 months before screening
Participant is expected to require treatment or prophylaxis with an antiviral with anti-CMV activity during the study
