Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT01663740

CompletedPhase 4

Sponsor: Hoffmann-La Roche

Conditions: Cytomegalovirus Infections

Interventions: Valganciclovir

Countries: United States, Mexico

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.

Eligibility overview

Sex: MALE

Age: 20 Years to 50 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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)
Locations (19)
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • San Francisco, California, United States
  • Washington D.C., District of Columbia, United States
  • Augusta, Georgia, United States
  • Boston, Massachusetts, United States
  • Springfield, Massachusetts, United States
  • Minneapolis, Minnesota, United States
  • Rochester, Minnesota, United States
  • Albany, New York, United States
  • Buffalo, New York, United States
  • Stony Brook, New York, United States
  • Portland, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Providence, Rhode Island, United States
  • San Antonio, Texas, United States
  • Aguascalientes, Mexico
  • Cuernavaca, Mexico
  • San Luis Potosí City, Mexico