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Completed

NCT Number: NCT01663740

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

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Key information

Conditions

Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Miguel Hidalgo, Aguascalientes, Mexico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Valganciclovir

Drug

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

Other names: Valcyte®

Primary outcomes

  1. Change in Sperm Density From Baseline to the End of Treatment (EOT)

    Time frame: Baseline, EOT (Week 28)

    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 outcomes

  1. 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)

    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.

  2. Change in TUNEL Score From EOT to End of FU

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

    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.

  3. Change in Seminal Volume From Baseline to EOT and End of FU

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

    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).

  4. Change in Seminal Volume From EOT to End FU

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

    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).

  5. Change in Sperm Density From EOT to End of FU

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

    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).

  6. Change in Sperm Density From Baseline to End of FU

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

    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).

  7. 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)

    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).

  8. Change in Total Motility of Sperm From EOT to End of FU

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

    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).

  9. 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)

    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.

  10. 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)

    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.

  11. Change in Total Testosterone Level From Baseline to EOT and End of FU

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

    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.

  12. Change in Total Testosterone Level From EOT to End of FU

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

    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.

  13. Change in LH Level From Baseline to EOT and End of FU

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

    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.

  14. Change in LH Level From EOT to End of FU

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

    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.

  15. Change in FSH Level From Baseline to EOT and End of FU

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

    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.

  16. Change in FSH Level From EOT to End of FU

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

    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.

  17. Change in Prolactin Level From Baseline to EOT and End of FU

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

    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.

  18. Change in Prolactin Level From EOT to End of FU

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

    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.

  19. Change in Inhibin B Level From Baseline to EOT and End of FU

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

    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.

  20. Change in Inhibin B Level From EOT to End of FU

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

    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.

  21. 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)

    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.

  22. 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)

    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.

  23. 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)

    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.

  24. Percentage of Participants With Improved TUNEL Score From EOT to End of FU

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

    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.

  25. 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)

    Participants who had higher sperm density compared with the previous visit were considered as improved.

  26. Percentage of Participants With Improved Sperm Density From EOT to End of FU

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

    Participants who had higher sperm density compared with the previous visit were considered as improved.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Aug 13, 2012
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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