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Trial record 6 of 101 for:    Valcyte

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

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ClinicalTrials.gov Identifier: NCT01663740
Recruitment Status : Completed
First Posted : August 13, 2012
Results First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Cytomegalovirus Infections Drug: Valganciclovir Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : January 30, 2012
Actual Primary Completion Date : September 29, 2015
Actual Study Completion Date : December 30, 2016


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.
Drug: Valganciclovir
Participants will receive valganciclovir 900 milligrams (mg) orally once daily for up to a maximum of 200 days post-transplant.
Other Name: Valcyte®

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663740


Locations
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United States, California
National Institute of Transplantation
Los Angeles, California, United States, 90057
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90095
University of California at San Francisco
San Francisco, California, United States, 94115
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Western New England Renal & Transplant Associates, P.C.
Springfield, Massachusetts, United States, 01107
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55902
United States, New York
Albany Medical Cancer Center
Albany, New York, United States, 12208
University at Buffalo
Buffalo, New York, United States, 14203
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
United States, Oregon
Oregan Health & Science Univ
Portland, Oregon, United States, 97237
United States, Pennsylvania
Drexel University Department of Nephrology
Philadelphia, Pennsylvania, United States, 19102
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Texas
Methodist Healthcare System of San Antonio
San Antonio, Texas, United States, 78229
Mexico
Hospital Miguel Hidalgo
Aguascalientes, Mexico, 20230
Instituto Mexicano de Trasplantes
Cuernavaca, Mexico, 62448
Hospital Central Dr. Ignacio Morones Prieto
San Luis Potosi, Mexico, 78240
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01663740     History of Changes
Other Study ID Numbers: WV25651
First Posted: August 13, 2012    Key Record Dates
Results First Posted: August 31, 2018
Last Update Posted: August 31, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valganciclovir
Antiviral Agents
Anti-Infective Agents