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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01663740
First received: August 9, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This observational study will compare spermatogenesis in male adult renal transp lant recipients receiving valganciclovir versus untreated matched controls. Data will be collected from each patient for up to 52 weeks post transplant.


Condition
Cytomegalovirus Infections, Transplantation

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change of sperm density at end of treatment [ Time Frame: from baseline up to Day 200 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of DNA fragmentation changes [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Semen: volume, sperm density/motility/morphology [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Hormone/biomarker levels (FSH/LH/testosterone/prolactin/inhibin B) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 37
Study Start Date: January 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult male renal transplant recipients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663740

Contacts
Contact: Reference Study ID Number: WV25651 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
United States, California
Completed
Los Angeles, California, United States, 90057
Recruiting
Los Angeles, California, United States, 90095
Active, not recruiting
San Francisco, California, United States, 94115
United States, District of Columbia
Terminated
Washington, District of Columbia, United States, 20010
United States, Georgia
Recruiting
Augusta, Georgia, United States, 30912
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02111
Completed
Springfield, Massachusetts, United States, 01107
United States, Minnesota
Active, not recruiting
Minneapolis, Minnesota, United States, 55455
Completed
Rochester, Minnesota, United States, 55905
United States, New York
Recruiting
Albany, New York, United States, 12208
Recruiting
Buffalo, New York, United States, 14203
Active, not recruiting
Stony Brook, New York, United States, 11794
United States, Oregon
Completed
Portland, Oregon, United States, 97237
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States, 19102
United States, Rhode Island
Recruiting
Providence, Rhode Island, United States, 02903
United States, Texas
Recruiting
San Antonio, Texas, United States, 78229
Mexico
Recruiting
Aguascalientes, Mexico, 20230
Recruiting
Cuernavaca, Mexico, 62448
Recruiting
San Luis Potosi S.L.P., Mexico, 78240
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01663740     History of Changes
Other Study ID Numbers: WV25651
Study First Received: August 9, 2012
Last Updated: August 4, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cytomegalovirus Infections
DNA Virus Infections
Herpesviridae Infections
Virus Diseases
Valganciclovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014