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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01663740
Recruitment Status : Completed
First Posted : August 13, 2012
Last Update Posted : April 26, 2017
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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 patient for up to 52 weeks post transplant.

Condition or disease
Cytomegalovirus Infections, Transplantation

Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : January 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015


Primary Outcome Measures :
  1. Change of sperm density at end of treatment [ Time Frame: from baseline up to Day 200 ]

Secondary Outcome Measures :
  1. Percentage of DNA fragmentation changes [ Time Frame: 52 weeks ]
  2. Semen: volume, sperm density/motility/morphology [ Time Frame: 52 weeks ]
  3. Hormone/biomarker levels (FSH/LH/testosterone/prolactin/inhibin B) [ Time Frame: 52 weeks ]

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male adult renal transplant patients with no evidence of known infertility in US and Mexico.

Inclusion Criteria:

  • Male patient, >/= 20 to </= 50 years of age
  • First renal transplant
  • Patient eligible to receive at least 100 days or up to 200 days valganciclovir prophylaxis as determined by the treating physician in accordance with the product information (Cohort A only) or the patient is not expected to require any valganciclovir prophylaxis (Cohort B only) post-transplant
  • Patient has no history of known infertility
  • Patient is willing to provide sperm samples
  • Patient agrees to use 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
  • Has received an investigational new drug in the 3 months prior to transplant
  • Receiving an alkylating agent or other medications known to affect spermatogenesis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01663740

United States, California
Los Angeles, California, United States, 90057
Los Angeles, California, United States, 90095
San Francisco, California, United States, 94115
United States, District of Columbia
Washington, D.C., District of Columbia, United States, 20010
United States, Georgia
Augusta, Georgia, United States, 30912
United States, Massachusetts
Boston, Massachusetts, United States, 02111
Springfield, Massachusetts, United States, 01107
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
Rochester, Minnesota, United States, 55905
United States, New York
Albany, New York, United States, 12208
Buffalo, New York, United States, 14203
Stony Brook, New York, United States, 11794
United States, Oregon
Portland, Oregon, United States, 97237
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19102
United States, Rhode Island
Providence, Rhode Island, United States, 02903
United States, Texas
San Antonio, Texas, United States, 78229
Aguascalientes, Mexico, 20230
Cuernavaca, Mexico, 62448
San Luis Potosi S.L.P., Mexico, 78240
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01663740     History of Changes
Other Study ID Numbers: WV25651
First Posted: August 13, 2012    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: November 2016

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Antiviral Agents
Anti-Infective Agents