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

Status:	Completed
Conditions:	Hospital
Therapuetic Areas:	Other
Healthy:	No
Age Range:	20 - 50
Updated:	9/2/2018
Start Date:	January 30, 2012
End Date:	December 30, 2016

A Multicenter Prospective Cohort Study to Investigate if Ganciclovir Significantly Affects Spermatogenesis in Adult Male Renal Transplant Recipients Receiving up to 200 Days Valganciclovir Vs. Concurrent Untreated Matched Controls

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.

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)

We found this trial at

sites

Medical College of Georgia

598 Telfair Street
Augusta, Georgia 30912

from

Augusta, GA