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

Roche

Status and phase: Completed; Phase 4

Conditions: Cytomegalovirus Infections

Treatments: Drug: Valganciclovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01663740

WV25651

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

59 participants in 2 patient groups

Cohort A: Partcipants who Received Valganciclovir

Experimental group

Description:

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.

Treatment:

Drug: Valganciclovir

Cohort B: Untreated Participants

No Intervention group

Description:

Participants with donor negative (D-)/R- CMV serology, who do not receive prophylaxis, will be observed for spermatogenesis up to 52 weeks post-transplant.