Transplant-associated cytomegalovirus (CMV) infection MedDRA version: 20.1 Level: PT Classification code 10011831 Term: Cytomegalovirus infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.1 Level: LLT Classification code 10058881 Term: Cytomegalovirus viremia System Organ Class: 10021881 - Infections
Conditions
Interventions
Product Name: MCMV5322A
Product Code: RO6855849
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: N/A
Curr
Sponsors
Genentech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patient is scheduled to receive a primary or secondary renal allograft from a living or cadaveric donor. •Patient is seronegative for CMV •Ability and willingness to provide written informed consent(s) and to comply with the requirements of the protocol •Men and women aged > 18 years •Female patients of childbearing potential must have negative urine pregnancy test result on Day 1. •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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 105 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: •Patient is suspected of having CMV disease. •Patient 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 patients receiving acyclovir or valacyclovir at doses to suppress herpes zoster). •Patients 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 •Patients who have received B cell-depleting therapies (rituximab) within 3 months before transplantation or with the expectation of receiving rituximab at the time of transplantation or in the 3 months after transplantation. •Patient 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 (AST or ALT) or bilirubin (total or free) - 2 - upper limit of normal (ULN). •Patient is unlikely or unwilling to be available for follow-up for the full 24-week duration of the study. •Female patients 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 •Active treatment for untreated tuberculosis or other infectious conditions that are significant in the judgment of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the safety of multiple IV doses of MCMV5322A/MCMV3068A given to cytomegalovirus (CMV) seronegative recipients of a renal transplant from a CMV seropositive donor. •To determine the clinical activity of multiple IV doses of MCMV5322A/MCMV3068A given to CMV-seronegative recipients of a renal transplant from a CMV-seropositive donor. ; Secondary Objective: •To characterize the pharmacokinetic (PK) profile of multiple doses of MCMV5322A/MCMV3068A •To characterize the immunogenic potential of MCMV5322A/MCMV3068A by measuring anti-MCMV5322A and anti-MCMV3068A antibodies ;Primary end point(s): •Detectable CMV viremia within the first 12 weeks after transplantation, defined as at least one CMV viral load > 150 copies/mL as assessed by the central laboratory.;Timepoint(s) of evaluation of this end point: see section E.5.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: See section E.5.2.1; Secondary end point(s): •Detectable CMV viremia within the first 24 weeks after transplantation, defined as at least one CMV viral load > 150 copies/mL as assessed by the central laboratory. •Time to detectable CMV viremia, defined as time from transplant to first CMV viral load >150 copies/mL as assessed by the central laboratory •Viral load at first detection of CMV viremia (> 150 copies/mL) as assessed by the central laboratory •Peak viral load on or following first detection of CMV viremia (> 150 copies/mL) as assessed by the central laboratory •Initiation of preemptive antiviral therapy during the first 12 weeks after transplantation •Initiation of preemptive antiviral therapy during the first 24 weeks after transplantation •Time to initiation of first use of preemptive antiviral therapy •Duration of first use of preemptive antiviral therapy initiated during the first 12 weeks after transplantation •Duration of all use of preemptive antiviral therapy initiated during the first 24 weeks after transplantation •CMV disease (CMV syndrome or tissue-invasive disease as defined in Appendix 3) during the first 24 weeks after transplantation •Change in CMV serostatus as assessed by the central laboratory | — |
Countries
Belgium, France, Germany, Netherlands, Norway, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann La Roche Ltd.
Outcome results
None listed