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

August 1, 2018 updated by: Hoffmann-La Roche

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline, EOT (Week 28)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, EOT (Week 28), end of FU (Week 52)
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.
EOT (Week 28), end of FU (Week 52)
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).
Baseline, EOT (Week 28), end of FU (Week 52)
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).
EOT (Week 28), end of FU (Week 52)
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).
EOT (Week 28), end of FU (Week 52)
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).
Baseline, end of FU (Week 52)
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).
Baseline, EOT (Week 28), end of FU (Week 52)
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).
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
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.
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
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.
EOT (Week 28), end of FU (Week 52)
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.
Baseline, EOT (Week 28), end of FU (Week 52)
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.
EOT (Week 28), end of FU (Week 52)
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.
Baseline, EOT (Week 28), end of FU (Week 52)
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.
EOT (Week 28), end of FU (Week 52)
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.
Baseline, EOT (Week 28), end of FU (Week 52)
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.
EOT (Week 28), end of FU (Week 52)
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.
Baseline, EOT (Week 28), end of FU (Week 52)
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.
EOT (Week 28), end of FU (Week 52)
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.
Baseline, EOT (Week 28), end of FU (Week 52)
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.
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
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.
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
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.
EOT (Week 28), end of FU (Week 52)
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.
Baseline, EOT (Week 28), end of FU (Week 52)
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.
EOT (Week 28), end of FU (Week 52)
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.
Baseline, EOT (Week 28), end of FU (Week 52)
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.
EOT (Week 28), end of FU (Week 52)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 29, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WV25651

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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