Clinical Trials Directory

Trials / Completed

CompletedNCT01663740

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

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
59 (actual)
Sponsor
Hoffmann-La Roche · Industry
Sex
Male
Age
20 Years – 50 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGValganciclovirParticipants will receive valganciclovir 900 milligrams (mg) orally once daily for up to a maximum of 200 days post-transplant.

Timeline

Start date
2012-01-30
Primary completion
2015-09-29
Completion
2016-12-30
First posted
2012-08-13
Last updated
2018-08-31
Results posted
2018-08-31

Locations

19 sites across 2 countries: United States, Mexico

Source: ClinicalTrials.gov record NCT01663740. Inclusion in this directory is not an endorsement.