Back to resultsA Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls
Primary Purpose
Cytomegalovirus Infections
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Valganciclovir
Sponsored by
About this trial
This is an interventional other trial for Cytomegalovirus Infections
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)
Sites / Locations
- National Institute of Transplantation
- University of California Los Angeles (UCLA)
- University of California at San Francisco
- Washington Hospital Center
- Medical College of Georgia
- Tufts Medical Center
- Western New England Renal & Transplant Associates, P.C.
- University of Minnesota
- Mayo Clinic Rochester
- Albany Medical Cancer Center
- University at Buffalo
- Stony Brook University Hospital
- Oregan Health & Science Univ
- Drexel University Department of Nephrology
- Rhode Island Hospital
- Methodist Healthcare System of San Antonio
- Hospital Miguel Hidalgo
- Instituto Mexicano de Trasplantes
- Hospital Central Dr. Ignacio Morones Prieto
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cohort A: Partcipants who Received Valganciclovir
Cohort B: Untreated Participants
Arm Description
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.
Participants with donor negative (D-)/R- CMV serology, who do not receive prophylaxis, will be observed for spermatogenesis up to 52 weeks post-transplant.
Outcomes
Primary Outcome Measures
Change in Sperm Density From Baseline to the End of Treatment (EOT)
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).
Secondary Outcome Measures
Change in Terminal Uridine Nick-End Labeling (TUNEL) Score From Baseline to EOT and End of Follow-up (FU)
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.
Change in TUNEL Score From EOT to End of FU
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.
Change in Seminal Volume From Baseline to EOT and End of FU
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).
Change in Seminal Volume From EOT to End FU
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).
Change in Sperm Density From EOT to End of FU
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).
Change in Sperm Density From Baseline to End of FU
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).
Change in Total Motility of Sperm From Baseline to EOT and End of FU
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).
Change in Total Motility of Sperm From EOT to End of FU
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).
Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From Baseline to EOT and End of FU
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.
Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From EOT to End of FU
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.
Change in Total Testosterone Level From Baseline to EOT and End of FU
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.
Change in Total Testosterone Level From EOT to End of FU
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.
Change in LH Level From Baseline to EOT and End of FU
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.
Change in LH Level From EOT to End of FU
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.
Change in FSH Level From Baseline to EOT and End of FU
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.
Change in FSH Level From EOT to End of FU
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.
Change in Prolactin Level From Baseline to EOT and End of FU
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.
Change in Prolactin Level From EOT to End of FU
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.
Change in Inhibin B Level From Baseline to EOT and End of FU
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.
Change in Inhibin B Level From EOT to End of FU
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.
Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From Baseline to EOT and End of FU
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.
Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From EOT to End of FU
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.
Percentage of Participants With Improved TUNEL Score From Baseline to EOT and End of FU
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.
Percentage of Participants With Improved TUNEL Score From EOT to End of FU
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.
Percentage of Participants With Improved Sperm Density From Baseline to EOT and End of FU
Participants who had higher sperm density compared with the previous visit were considered as improved.
Percentage of Participants With Improved Sperm Density From EOT to End of FU
Participants who had higher sperm density compared with the previous visit were considered as improved.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01663740
Brief Title
A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 30, 2012 (Actual)
Primary Completion Date
September 29, 2015 (Actual)
Study Completion Date
December 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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 participant for up to 52 weeks post transplant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infections
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort A: Partcipants who Received Valganciclovir
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort B: Untreated Participants
Arm Type
No Intervention
Arm Description
Participants with donor negative (D-)/R- CMV serology, who do not receive prophylaxis, will be observed for spermatogenesis up to 52 weeks post-transplant.
Intervention Type
Drug
Intervention Name(s)
Valganciclovir
Other Intervention Name(s)
Valcyte®
Intervention Description
Participants will receive valganciclovir 900 milligrams (mg) orally once daily for up to a maximum of 200 days post-transplant.
Primary Outcome Measure Information:
Title
Change in Sperm Density From Baseline to the End of Treatment (EOT)
Description
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).
Time Frame
Baseline, EOT (Week 28)
Secondary Outcome Measure Information:
Title
Change in Terminal Uridine Nick-End Labeling (TUNEL) Score From Baseline to EOT and End of Follow-up (FU)
Description
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.
Time Frame
Baseline, EOT (Week 28), end of FU (Week 52)
Title
Change in TUNEL Score From EOT to End of FU
Description
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.
Time Frame
EOT (Week 28), end of FU (Week 52)
Title
Change in Seminal Volume From Baseline to EOT and End of FU
Description
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).
Time Frame
Baseline, EOT (Week 28), end of FU (Week 52)
Title
Change in Seminal Volume From EOT to End FU
Description
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).
Time Frame
EOT (Week 28), end of FU (Week 52)
Title
Change in Sperm Density From EOT to End of FU
Description
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).
Time Frame
EOT (Week 28), end of FU (Week 52)
Title
Change in Sperm Density From Baseline to End of FU
Description
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).
Time Frame
Baseline, end of FU (Week 52)
Title
Change in Total Motility of Sperm From Baseline to EOT and End of FU
Description
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).
Time Frame
Baseline, EOT (Week 28), end of FU (Week 52)
Title
Change in Total Motility of Sperm From EOT to End of FU
Description
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).
Time Frame
EOT (Week 28), end of FU (Week 52)
Title
Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From Baseline to EOT and End of FU
Description
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.
Time Frame
Baseline, EOT (Week 28), end of FU (Week 52)
Title
Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From EOT to End of FU
Description
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.
Time Frame
EOT (Week 28), end of FU (Week 52)
Title
Change in Total Testosterone Level From Baseline to EOT and End of FU
Description
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.
Time Frame
Baseline, EOT (Week 28), end of FU (Week 52)
Title
Change in Total Testosterone Level From EOT to End of FU
Description
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.
Time Frame
EOT (Week 28), end of FU (Week 52)
Title
Change in LH Level From Baseline to EOT and End of FU
Description
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.
Time Frame
Baseline, EOT (Week 28), end of FU (Week 52)
Title
Change in LH Level From EOT to End of FU
Description
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.
Time Frame
EOT (Week 28), end of FU (Week 52)
Title
Change in FSH Level From Baseline to EOT and End of FU
Description
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.
Time Frame
Baseline, EOT (Week 28), end of FU (Week 52)
Title
Change in FSH Level From EOT to End of FU
Description
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.
Time Frame
EOT (Week 28), end of FU (Week 52)
Title
Change in Prolactin Level From Baseline to EOT and End of FU
Description
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.
Time Frame
Baseline, EOT (Week 28), end of FU (Week 52)
Title
Change in Prolactin Level From EOT to End of FU
Description
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.
Time Frame
EOT (Week 28), end of FU (Week 52)
Title
Change in Inhibin B Level From Baseline to EOT and End of FU
Description
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.
Time Frame
Baseline, EOT (Week 28), end of FU (Week 52)
Title
Change in Inhibin B Level From EOT to End of FU
Description
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.
Time Frame
EOT (Week 28), end of FU (Week 52)
Title
Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From Baseline to EOT and End of FU
Description
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.
Time Frame
Baseline, EOT (Week 28), end of FU (Week 52)
Title
Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From EOT to End of FU
Description
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.
Time Frame
EOT (Week 28), end of FU (Week 52)
Title
Percentage of Participants With Improved TUNEL Score From Baseline to EOT and End of FU
Description
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.
Time Frame
Baseline, EOT (Week 28), end of FU (Week 52)
Title
Percentage of Participants With Improved TUNEL Score From EOT to End of FU
Description
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.
Time Frame
EOT (Week 28), end of FU (Week 52)
Title
Percentage of Participants With Improved Sperm Density From Baseline to EOT and End of FU
Description
Participants who had higher sperm density compared with the previous visit were considered as improved.
Time Frame
Baseline, EOT (Week 28), end of FU (Week 52)
Title
Percentage of Participants With Improved Sperm Density From EOT to End of FU
Description
Participants who had higher sperm density compared with the previous visit were considered as improved.
Time Frame
EOT (Week 28), end of FU (Week 52)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
National Institute of Transplantation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
University of California Los Angeles (UCLA)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Western New England Renal & Transplant Associates, P.C.
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Albany Medical Cancer Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Oregan Health & Science Univ
City
Portland
State/Province
Oregon
ZIP/Postal Code
97237
Country
United States
Facility Name
Drexel University Department of Nephrology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Methodist Healthcare System of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Hospital Miguel Hidalgo
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Instituto Mexicano de Trasplantes
City
Cuernavaca
ZIP/Postal Code
62448
Country
Mexico
Facility Name
Hospital Central Dr. Ignacio Morones Prieto
City
San Luis Potosi
ZIP/Postal Code
78240
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls
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