- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01663740
A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls
August 1, 2018 updated by: Hoffmann-La Roche
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aguascalientes, Mexico, 20230
- Hospital Miguel Hidalgo
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Cuernavaca, Mexico, 62448
- Instituto Mexicano de Trasplantes
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San Luis Potosi, Mexico, 78240
- Hospital Central Dr. Ignacio Morones Prieto
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California
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Los Angeles, California, United States, 90095
- University of California Los Angeles (UCLA)
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Los Angeles, California, United States, 90057
- National Institute of Transplantation
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San Francisco, California, United States, 94115
- University of California at San Francisco
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Washington Hospital Center
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Georgia
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Augusta, Georgia, United States, 30912
- Medical College of Georgia
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts Medical Center
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Springfield, Massachusetts, United States, 01107
- Western New England Renal & Transplant Associates, P.C.
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Rochester, Minnesota, United States, 55902
- Mayo Clinic Rochester
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New York
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Albany, New York, United States, 12208
- Albany Medical Cancer Center
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Buffalo, New York, United States, 14203
- University at Buffalo
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Stony Brook, New York, United States, 11794
- Stony Brook University Hospital
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Oregon
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Portland, Oregon, United States, 97237
- Oregan Health & Science Univ
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19102
- Drexel University Department of Nephrology
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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Texas
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San Antonio, Texas, United States, 78229
- Methodist Healthcare System of San Antonio
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort A: Partcipants who Received Valganciclovir
Participants with donor positive (D+)/recipient negative (R-) cytomegalovirus (CMV) serology, who receive valganciclovir prophylaxis according to the local prescribing information, will be observed for spermatogenesis up to 52 weeks post-transplant.
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Participants will receive valganciclovir 900 milligrams (mg) orally once daily for up to a maximum of 200 days post-transplant.
Other Names:
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No Intervention: Cohort B: Untreated Participants
Participants with donor negative (D-)/R- CMV serology, who do not receive prophylaxis, will be observed for spermatogenesis up to 52 weeks post-transplant.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Sperm Density From Baseline to the End of Treatment (EOT)
Time Frame: Baseline, EOT (Week 28)
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Sperm density was calculated based on the average of two semen samples.
Change was calculated as the sperm density measured at post-baseline visit (EOT) minus (-) the sperm density measured at baseline for each participant.
A negative change from baseline indicated a lower sperm density (worsening).
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Baseline, EOT (Week 28)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Terminal Uridine Nick-End Labeling (TUNEL) Score From Baseline to EOT and End of Follow-up (FU)
Time Frame: Baseline, EOT (Week 28), end of FU (Week 52)
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Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score.
Change was calculated as the TUNEL score measured at post-baseline visit (EOT and FU) minus the TUNEL score measured at baseline for each participant.
A negative change from baseline indicated a lower TUNEL score.
TUNEL score represents percentage of sperm with fragmented DNA; total score ranged from 0 percent (%) to 100%, higher score represents more fragmentation.
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Baseline, EOT (Week 28), end of FU (Week 52)
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Change in TUNEL Score From EOT to End of FU
Time Frame: EOT (Week 28), end of FU (Week 52)
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Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score.
Change was calculated as the TUNEL score measured at FU minus the TUNEL score measured at EOT for each participant.
A negative change from EOT indicated a lower TUNEL score.
TUNEL score represents percentage of sperm with fragmented DNA; total score ranged from 0% to 100%, higher score represents more fragmentation.
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EOT (Week 28), end of FU (Week 52)
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Change in Seminal Volume From Baseline to EOT and End of FU
Time Frame: Baseline, EOT (Week 28), end of FU (Week 52)
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Seminal volume was calculated based on the average of two semen samples.
Change was calculated as the seminal volume measured at post-baseline visit (EOT and FU) - the seminal volume measured at baseline for each participant.
A negative change from baseline indicated a lower seminal volume (worsening).
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Baseline, EOT (Week 28), end of FU (Week 52)
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Change in Seminal Volume From EOT to End FU
Time Frame: EOT (Week 28), end of FU (Week 52)
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Seminal volume was calculated based on the average of two semen samples.
Change was calculated as the seminal volume measured at FU - the seminal volume measured at EOT for each participant.
A negative change from EOT indicated a lower seminal volume (worsening).
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EOT (Week 28), end of FU (Week 52)
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Change in Sperm Density From EOT to End of FU
Time Frame: EOT (Week 28), end of FU (Week 52)
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Sperm density was calculated based on the average of two semen samples.
Change was calculated as the sperm density measured at FU - the sperm density measured at EOT for each participant.
A negative change from EOT indicated a lower sperm density (worsening).
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EOT (Week 28), end of FU (Week 52)
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Change in Sperm Density From Baseline to End of FU
Time Frame: Baseline, end of FU (Week 52)
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Sperm density was calculated based on the average of two semen samples.
Change was calculated as the sperm density measured at post-baseline visit (FU) - the sperm density measured at baseline for each participant.
A negative change from baseline indicated a lower sperm density (worsening).
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Baseline, end of FU (Week 52)
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Change in Total Motility of Sperm From Baseline to EOT and End of FU
Time Frame: Baseline, EOT (Week 28), end of FU (Week 52)
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Sperm motility was calculated based on the average of two semen samples.
Percent was determined by the calculation of motile sperm/total sperm count.
Change was calculated as the sperm motility measured at post-baseline visit (EOT and FU) - the sperm motility measured at baseline for each participant.
A negative change from baseline indicated a lower sperm motility (worsening).
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Baseline, EOT (Week 28), end of FU (Week 52)
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Change in Total Motility of Sperm From EOT to End of FU
Time Frame: EOT (Week 28), end of FU (Week 52)
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Sperm motility was calculated based on the average of two semen samples.
Percent was determined by the calculation of motile sperm/total sperm count.
Change was calculated as the sperm motility measured at FU - the sperm motility measured at EOT for each participant.
A negative change from EOT indicated a lower sperm motility (worsening).
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EOT (Week 28), end of FU (Week 52)
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Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From Baseline to EOT and End of FU
Time Frame: Baseline, EOT (Week 28), end of FU (Week 52)
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Sperm morphology was evaluated based on the average of two semen samples.
Change was calculated as the sperm morphology measured at post-baseline visit (EOT and FU) - the sperm morphology measured at baseline for each participant.
A positive change from baseline indicated an improved sperm morphology.
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Baseline, EOT (Week 28), end of FU (Week 52)
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Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From EOT to End of FU
Time Frame: EOT (Week 28), end of FU (Week 52)
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Sperm morphology was evaluated based on the average of two semen samples.
Change was calculated as the sperm morphology measured at FU - the sperm morphology measured at EOT for each participant.
A positive change from EOT indicated an improved sperm morphology.
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EOT (Week 28), end of FU (Week 52)
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Change in Total Testosterone Level From Baseline to EOT and End of FU
Time Frame: Baseline, EOT (Week 28), end of FU (Week 52)
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Testosterone level was calculated based on the average of two samples.
Change was calculated as the testosterone level measured at post-baseline visit (EOT and FU) - the testosterone level measured at baseline for each participant.
A negative change from baseline indicated a lower testosterone level.
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Baseline, EOT (Week 28), end of FU (Week 52)
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Change in Total Testosterone Level From EOT to End of FU
Time Frame: EOT (Week 28), end of FU (Week 52)
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Testosterone level was calculated based on the average of two samples.
Change was calculated as the testosterone level measured at FU - the testosterone level measured at EOT for each participant.
A negative change from EOT indicated a lower testosterone level.
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EOT (Week 28), end of FU (Week 52)
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Change in LH Level From Baseline to EOT and End of FU
Time Frame: Baseline, EOT (Week 28), end of FU (Week 52)
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LH level was calculated based on the average of two samples.
Change was calculated as the LH level measured at post-baseline visit (EOT and FU) - the LH level measured at baseline for each participant.
A negative change from baseline indicated a lower LH level.
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Baseline, EOT (Week 28), end of FU (Week 52)
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Change in LH Level From EOT to End of FU
Time Frame: EOT (Week 28), end of FU (Week 52)
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LH level was calculated based on the average of two samples.
Change was calculated as the LH level measured at FU - the LH level measured at EOT for each participant.
A negative change from EOT indicated a lower LH level.
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EOT (Week 28), end of FU (Week 52)
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Change in FSH Level From Baseline to EOT and End of FU
Time Frame: Baseline, EOT (Week 28), end of FU (Week 52)
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FSH level was calculated based on the average of two samples.
Change was calculated as the FSH level measured at post-baseline visit (EOT and FU) - the FSH level measured at baseline for each participant.
A negative change from baseline indicated a lower FSH level.
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Baseline, EOT (Week 28), end of FU (Week 52)
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Change in FSH Level From EOT to End of FU
Time Frame: EOT (Week 28), end of FU (Week 52)
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FSH level was calculated based on the average of two samples.
Change was calculated as the FSH level measured at FU - the FSH level measured at EOT for each participant.
A negative change from EOT indicated a lower FSH level.
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EOT (Week 28), end of FU (Week 52)
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Change in Prolactin Level From Baseline to EOT and End of FU
Time Frame: Baseline, EOT (Week 28), end of FU (Week 52)
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Prolactin level was calculated based on the average of two samples.
Change was calculated as the prolactin level measured at post-baseline visit (EOT and FU) - the prolactin level measured at baseline for each participant.
A negative change from baseline indicated a lower prolactin level.
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Baseline, EOT (Week 28), end of FU (Week 52)
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Change in Prolactin Level From EOT to End of FU
Time Frame: EOT (Week 28), end of FU (Week 52)
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Prolactin level was calculated based on the average of two samples.
Change was calculated as the prolactin level measured at FU - the prolactin level measured at EOT for each participant.
A negative change from EOT indicated a lower prolactin level.
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EOT (Week 28), end of FU (Week 52)
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Change in Inhibin B Level From Baseline to EOT and End of FU
Time Frame: Baseline, EOT (Week 28), end of FU (Week 52)
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Inhibin B level was calculated based on the average of two samples.
Change was calculated as the inhibin B level measured at post-baseline visit (EOT and FU) - the inhibin B level measured at baseline for each participant.
A negative change from baseline indicated a lower inhibin B level.
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Baseline, EOT (Week 28), end of FU (Week 52)
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Change in Inhibin B Level From EOT to End of FU
Time Frame: EOT (Week 28), end of FU (Week 52)
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Inhibin B level was calculated based on the average of two samples.
Change was calculated as the inhibin B level measured at FU - the inhibin B level measured at EOT for each participant.
A negative change from EOT indicated a lower inhibin B level.
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EOT (Week 28), end of FU (Week 52)
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Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From Baseline to EOT and End of FU
Time Frame: Baseline, EOT (Week 28), end of FU (Week 52)
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Abnormal sperm density was considered as sperm density less than (<) 20 mil/mL.
Change in abnormal to abnormal sperm density and normal to abnormal sperm density from baseline to EOT and end of FU was reported.
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Baseline, EOT (Week 28), end of FU (Week 52)
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Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From EOT to End of FU
Time Frame: EOT (Week 28), end of FU (Week 52)
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Abnormal sperm density was considered as sperm density <20 mil/mL.
Change in abnormal to abnormal sperm density and normal to abnormal sperm density from EOT to end of FU was reported.
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EOT (Week 28), end of FU (Week 52)
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Percentage of Participants With Improved TUNEL Score From Baseline to EOT and End of FU
Time Frame: Baseline, EOT (Week 28), end of FU (Week 52)
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Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score.
Participants who had a lower TUNEL score compared to the previous time point were considered as improved.
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Baseline, EOT (Week 28), end of FU (Week 52)
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Percentage of Participants With Improved TUNEL Score From EOT to End of FU
Time Frame: EOT (Week 28), end of FU (Week 52)
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Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score.
Participants who had a lower TUNEL score compared to the previous time point were considered as improved.
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EOT (Week 28), end of FU (Week 52)
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Percentage of Participants With Improved Sperm Density From Baseline to EOT and End of FU
Time Frame: Baseline, EOT (Week 28), end of FU (Week 52)
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Participants who had higher sperm density compared with the previous visit were considered as improved.
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Baseline, EOT (Week 28), end of FU (Week 52)
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Percentage of Participants With Improved Sperm Density From EOT to End of FU
Time Frame: EOT (Week 28), end of FU (Week 52)
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Participants who had higher sperm density compared with the previous visit were considered as improved.
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EOT (Week 28), end of FU (Week 52)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2012
Primary Completion (Actual)
September 29, 2015
Study Completion (Actual)
December 30, 2016
Study Registration Dates
First Submitted
August 9, 2012
First Submitted That Met QC Criteria
August 9, 2012
First Posted (Estimate)
August 13, 2012
Study Record Updates
Last Update Posted (Actual)
August 31, 2018
Last Update Submitted That Met QC Criteria
August 1, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WV25651
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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