Clinical trial NCT01663740: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cytomegalovirus Infections
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-13
Enrollment: 59
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: Change in Sperm Density From Baseline to the End of Treatment (EOT)
timeFrame: Baseline, EOT (Week 28)
Secondary outcomes:
measure: Change in Terminal Uridine Nick-End Labeling (TUNEL) Score From Baseline to EOT and End of Follow-up (FU)
timeFrame: Baseline, EOT (Week 28), end of FU (Week 52)
measure: Change in TUNEL Score From EOT to End of FU
timeFrame: EOT (Week 28), end of FU (Week 52)
measure: Change in Seminal Volume From Baseline to EOT and End of FU
timeFrame: Baseline, EOT (Week 28), end of FU (Week 52)
measure: Change in Seminal Volume From EOT to End FU
timeFrame: EOT (Week 28), end of FU (Week 52)
measure: Change in Sperm Density From EOT to End of FU
timeFrame: EOT (Week 28), end of FU (Week 52)
measure: Change in Sperm Density From Baseline to End of FU
timeFrame: Baseline, end of FU (Week 52)
measure: Change in Total Motility of Sperm From Baseline to EOT and End of FU
timeFrame: Baseline, EOT (Week 28), end of FU (Week 52)
measure: Change in Total Motility of Sperm From EOT to End of FU
timeFrame: EOT (Week 28), end of FU (Week 52)
measure: Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From Baseline to EOT and End of FU
timeFrame: Baseline, EOT (Week 28), end of FU (Week 52)
measure: Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From EOT to End of FU
timeFrame: EOT (Week 28), end of FU (Week 52)
measure: Change in Total Testosterone Level From Baseline to EOT and End of FU
timeFrame: Baseline, EOT (Week 28), end of FU (Week 52)
measure: Change in Total Testosterone Level From EOT to End of FU
timeFrame: EOT (Week 28), end of FU (Week 52)
measure: Change in LH Level From Baseline to EOT and End of FU
timeFrame: Baseline, EOT (Week 28), end of FU (Week 52)
measure: Change in LH Level From EOT to End of FU
timeFrame: EOT (Week 28), end of FU (Week 52)
measure: Change in FSH Level From Baseline to EOT and End of FU
timeFrame: Baseline, EOT (Week 28), end of FU (Week 52)
measure: Change in FSH Level From EOT to End of FU
timeFrame: EOT (Week 28), end of FU (Week 52)
measure: Change in Prolactin Level From Baseline to EOT and End of FU
timeFrame: Baseline, EOT (Week 28), end of FU (Week 52)
measure: Change in Prolactin Level From EOT to End of FU
timeFrame: EOT (Week 28), end of FU (Week 52)
measure: Change in Inhibin B Level From Baseline to EOT and End of FU
timeFrame: Baseline, EOT (Week 28), end of FU (Week 52)
measure: Change in Inhibin B Level From EOT to End of FU
timeFrame: EOT (Week 28), end of FU (Week 52)
measure: Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From Baseline to EOT and End of FU
timeFrame: Baseline, EOT (Week 28), end of FU (Week 52)
measure: Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From EOT to End of FU
timeFrame: EOT (Week 28), end of FU (Week 52)
measure: Percentage of Participants With Improved TUNEL Score From Baseline to EOT and End of FU
timeFrame: Baseline, EOT (Week 28), end of FU (Week 52)
measure: Percentage of Participants With Improved TUNEL Score From EOT to End of FU
timeFrame: EOT (Week 28), end of FU (Week 52)
measure: Percentage of Participants With Improved Sperm Density From Baseline to EOT and End of FU
timeFrame: Baseline, EOT (Week 28), end of FU (Week 52)
measure: Percentage of Participants With Improved Sperm Density From EOT to End of FU
timeFrame: EOT (Week 28), end of FU (Week 52)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: National Institute of Transplantation
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles (UCLA)
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Western New England Renal & Transplant Associates, P.C.
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Albany
country: United States
facility: Albany Medical Cancer Center
state: New York
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Portland
country: United States
facility: Oregan Health & Science Univ
state: Oregon
city: Philadelphia
country: United States
facility: Drexel University Department of Nephrology
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: San Antonio
country: United States
facility: Methodist Healthcare System of San Antonio
state: Texas
city: Aguascalientes
country: Mexico
facility: Hospital Miguel Hidalgo
city: Cuernavaca
country: Mexico
facility: Instituto Mexicano de Trasplantes
city: San Luis Potosi
country: Mexico
facility: Hospital Central Dr. Ignacio Morones Prieto
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: