A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls
NCT ID: NCT01663740
Last Updated: 2018-08-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
59 participants
INTERVENTIONAL
2012-01-30
2016-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
OTHER
NONE
Study Groups
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Cohort A: Partcipants who Received Valganciclovir
Participants with donor positive (D+)/recipient negative (R-) cytomegalovirus (CMV) serology, who receive valganciclovir prophylaxis according to the local prescribing information, will be observed for spermatogenesis up to 52 weeks post-transplant.
Valganciclovir
Participants will receive valganciclovir 900 milligrams (mg) orally once daily for up to a maximum of 200 days post-transplant.
Cohort B: Untreated Participants
Participants with donor negative (D-)/R- CMV serology, who do not receive prophylaxis, will be observed for spermatogenesis up to 52 weeks post-transplant.
No interventions assigned to this group
Interventions
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Valganciclovir
Participants will receive valganciclovir 900 milligrams (mg) orally once daily for up to a maximum of 200 days post-transplant.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant eligible to receive valganciclovir prophylaxis as determined by the treating physician in accordance with the local approved product prescribing information (Cohort A only) or the participant is not expected to require any valganciclovir prophylaxis (Cohort B only) post-transplant
* Participant has no history of known infertility
* Participant is able and willing to provide semen samples
* Participant agrees to utilize a barrier contraceptive throughout the study or for at least 90 days after cessation of valganciclovir treatment
Exclusion Criteria
* Organ transplant other than kidney
* Participant has received an investigational new drug in the 3 months prior to transplant
* Participant hs received an alkylating agent or other medications known to affect fertility/spermatogenesis
* Participant is unlikely to be available for follow-up for the entire duration of the study (up to 52 weeks)
20 Years
50 Years
MALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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National Institute of Transplantation
Los Angeles, California, United States
University of California Los Angeles (UCLA)
Los Angeles, California, United States
University of California at San Francisco
San Francisco, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Medical College of Georgia
Augusta, Georgia, United States
Tufts Medical Center
Boston, Massachusetts, United States
Western New England Renal & Transplant Associates, P.C.
Springfield, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Albany Medical Cancer Center
Albany, New York, United States
University at Buffalo
Buffalo, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Oregan Health & Science Univ
Portland, Oregon, United States
Drexel University Department of Nephrology
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Methodist Healthcare System of San Antonio
San Antonio, Texas, United States
Hospital Miguel Hidalgo
Aguascalientes, , Mexico
Instituto Mexicano de Trasplantes
Cuernavaca, , Mexico
Hospital Central Dr. Ignacio Morones Prieto
San Luis Potosí City, , Mexico
Countries
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Other Identifiers
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WV25651
Identifier Type: -
Identifier Source: org_study_id
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