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

Hoffmann-La Roche59 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Cytomegalovirus Infections

Interventions

ValganciclovirDRUG

Participants will receive valganciclovir 900 milligrams (mg) orally once daily for up to a maximum of 200 days post-transplant.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

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)

Locations (19)

National Institute of Transplantation

Los Angeles, California, United States

University of California Los Angeles (UCLA)

Outcomes

Primary Outcomes

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).

Time frame: Baseline, EOT (Week 28)

Secondary Outcomes

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.

Time frame: Baseline, EOT (Week 28), end of FU (Week 52)

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.

Time frame: EOT (Week 28), end of FU (Week 52)

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).

Time frame: Baseline, EOT (Week 28), end of FU (Week 52)

Data from ClinicalTrials.gov

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Los Angeles, California, United States

University of California at San Francisco

San Francisco, California, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Medical College of Georgia

Augusta, Georgia, United States

Tufts Medical Center

Boston, Massachusetts, United States

Western New England Renal & Transplant Associates, P.C.

Springfield, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Albany Medical Cancer Center

Albany, New York, United States

...and 9 more locations

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).

Time frame: EOT (Week 28), end of FU (Week 52)

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).

Time frame: EOT (Week 28), end of FU (Week 52)

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).

Time frame: Baseline, end of FU (Week 52)

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).

Time frame: Baseline, EOT (Week 28), end of FU (Week 52)

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).

Time frame: EOT (Week 28), end of FU (Week 52)

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.

Time frame: Baseline, EOT (Week 28), end of FU (Week 52)

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.

Time frame: EOT (Week 28), end of FU (Week 52)

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.

Time frame: Baseline, EOT (Week 28), end of FU (Week 52)

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.

Time frame: EOT (Week 28), end of FU (Week 52)

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.

Time frame: Baseline, EOT (Week 28), end of FU (Week 52)

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.

Time frame: EOT (Week 28), end of FU (Week 52)

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.

Time frame: Baseline, EOT (Week 28), end of FU (Week 52)

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.

Time frame: EOT (Week 28), end of FU (Week 52)

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.

Time frame: Baseline, EOT (Week 28), end of FU (Week 52)

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.

Time frame: EOT (Week 28), end of FU (Week 52)

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.

Time frame: Baseline, EOT (Week 28), end of FU (Week 52)

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.

Time frame: EOT (Week 28), end of FU (Week 52)

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.

Time frame: Baseline, EOT (Week 28), end of FU (Week 52)

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.

Time frame: EOT (Week 28), end of FU (Week 52)

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.

Time frame: Baseline, EOT (Week 28), end of FU (Week 52)

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.

Time frame: EOT (Week 28), end of FU (Week 52)

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.

Time frame: Baseline, EOT (Week 28), end of FU (Week 52)

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.

Time frame: EOT (Week 28), end of FU (Week 52)