A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls

Completed · Phase 4

Conditions studied: Cytomegalovirus Infections

In brief

This observational study will compare spermatogenesis in male adult renal transplant recipients receiving valganciclovir versus untreated matched controls. Data will be collected from each participant for up to 52 weeks post transplant.

Key facts

Study ID

NCT01663740

Run by

Hoffmann-La Roche

People needed

59

Starts

2012-01-30

Expected to finish

2016-12-30

Last updated by the study team

2018-08-31

Who can join

Age: 20 and older, up to 50. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• First renal transplant
• 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

You may not qualify if…

• Prior ganciclovir or valganciclovir within 3 months of enrollment
• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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