An Observational Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valcyte (Valganciclovir) Versus Untreated Matched Controls
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01663740
First received: August 9, 2012
Last updated: May 23, 2013
Last verified: May 2013
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Purpose
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 |
|---|
|
Transplantation, Cytomegalovirus Infections |
| 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: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cohort |
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
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 | |
| Recruiting | |
| Los Angeles, California, United States, 90095 | |
| Recruiting | |
| Los Angeles, California, United States, 90057 | |
| 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 | |
| Recruiting | |
| Springfield, Massachusetts, United States, 01107 | |
| United States, Minnesota | |
| Recruiting | |
| Minneapolis, Minnesota, United States, 55455 | |
| Recruiting | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New York | |
| Recruiting | |
| Albany, New York, United States, 12208 | |
| Recruiting | |
| Buffalo, New York, United States, 14203 | |
| Recruiting | |
| Stony Brook, New York, United States, 11794 | |
| United States, Oregon | |
| Recruiting | |
| 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 | |
| Not yet recruiting | |
| Aguascalientes, Mexico, 20230 | |
| Not yet recruiting | |
| Cuernavaca, Mexico, 62448 | |
| Not yet 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: | May 23, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases Valganciclovir |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013