A Study of MCMV5322A/MCMV3068A for the Prevention of Cytomegalovirus Disease in High-Risk Kidney Allograft Recipients
NCT ID: NCT01753167
Last Updated: 2017-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
122 participants
INTERVENTIONAL
2012-12-14
2014-10-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection
NCT04225923
CMV Glycoprotein B Vaccine in Allograft Recipients
NCT00299260
A Study of the Safety and Efficacy of CMX001 for the Prevention of CMV Infection in CMV-seropositive HCT Recipients
NCT01769170
Risk Factors for Cytomegalovirus Disease in Solid Organ Transplantation
NCT00170170
Cell-mediated Immunity for Prevention of CMV Disease
NCT02538172
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MCMV5322A/MCMV3068A
Participants will receive a total of four doses of study drug administered by intravenous infusion: at the time of transplantation (Day 1), and at Days 8, 29, and 57. MCMV5322A/MCMV3068A will be tested in this study at 10 milligrams per kilogram (mg/kg) of each component antibody. Thus, at each dose, 10 mg/kg of MCMV5322A and 10 mg/kg of MCMV3068A will be tested (20 mg/kg total).
MCMV3068A
Four doses of MCMV3068A (10 mg/kg) administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57.
MCMV5322A
Four doses of MCMV5322A (10 mg/kg) administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57.
Placebo
Participants will receive a total of four doses of placebo matched with MCMV5322A/MCMV3068A administered by intravenous infusion: at the time of transplantation (Day 1), and at Days 8, 29, and 57.
Placebo
Four doses of placebo matched to MCMV5322A/MCMV3068A administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MCMV3068A
Four doses of MCMV3068A (10 mg/kg) administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57.
MCMV5322A
Four doses of MCMV5322A (10 mg/kg) administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57.
Placebo
Four doses of placebo matched to MCMV5322A/MCMV3068A administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Genentech, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal Free Hospital
London, , United Kingdom
UCLA; Kidney & Pancreas Transplantation
Los Angeles, California, United States
California Inst. of Renal Research
San Diego, California, United States
Univ of CA San Francisco; Kidney Transplant Service
San Francisco, California, United States
University of Colorado Health Sciences Center; Dept of Medicine
Denver, Colorado, United States
Georgetown Uni Hospital; Division of Transplant Surgery
Washington D.C., District of Columbia, United States
MedStar Washington Hosp Center
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
Georgia Regents University
Augusta, Georgia, United States
Henry Ford Health System; Gastroenterology
Detroit, Michigan, United States
Washington Uni School of Medicine/Barnes Jewish Hospital; Renal
St Louis, Missouri, United States
Erie County Medical Center; Dept. of Nephrology
Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University
New York, New York, United States
University of Cincinnati / University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
Baylor Univ Medical Center
Dallas, Texas, United States
Clin Univ de Bxl Hôpital Erasme
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie
Bordeaux, , France
CHU de Nantes; Institut de transplantation urologie-néphrologie
Nantes, , France
Hopital Necker
Paris, , France
Hopital Rangueil; Gastro Enterologie Et Nutrition
Toulouse, , France
Chu De Tours
Tours, , France
Hopitaux De Brabois; Nephrologie
Vandœuvre-lès-Nancy, , France
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III
Dresden, , Germany
Universitätsklinikum Essen Zentrum f.Innere Medizin Abt.Nephrologie
Essen, , Germany
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik III
Frankfurt, , Germany
Uniklinikum Heidelberg
Heidelberg, , Germany
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, , Norway
Fundació Puigvert
Barcelona, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Barcelona, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
CEIC del Hospital Virgen del Rocío
Seville, Sevilla, Spain
Sahlgrenska Universitetssjukhuset; Jubileumskliniken
Gothenburg, , Sweden
Karolinska University Hospital
Huddinge, , Sweden
Akademiska Sjukhuset; Transplantation Surgery
Uppsala, , Sweden
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.
Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.
Deng R, Wang Y, Maia M, Burgess T, McBride JM, Liao XC, Tavel JA, Hanley WD. Pharmacokinetics and Exposure-Response Analysis of RG7667, a Combination of Two Anticytomegalovirus Monoclonal Antibodies, in a Phase 2a Randomized Trial To Prevent Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients. Antimicrob Agents Chemother. 2018 Jan 25;62(2):e01108-17. doi: 10.1128/AAC.01108-17. Print 2018 Feb.
Ishida JH, Patel A, Mehta AK, Gatault P, McBride JM, Burgess T, Derby MA, Snydman DR, Emu B, Feierbach B, Fouts AE, Maia M, Deng R, Rosenberger CM, Gennaro LA, Striano NS, Liao XC, Tavel JA. Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of RG7667, a Combination Monoclonal Antibody, for Prevention of Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e01794-16. doi: 10.1128/AAC.01794-16. Print 2017 Feb.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-002245-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GV28418
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.