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

Cytomegalovirus Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663740
• Other study ID #: WV25651
• Status: Completed
• Phase: Phase 4
• Start date: January 30, 2012
• Est. completion date: December 30, 2016

Study information

• Verified date: July 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 30, 2016
• Est. primary completion date: September 29, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cytomegalovirus Infections

Intervention

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

Locations

Country	Name	City	State
Mexico	Hospital Miguel Hidalgo	Aguascalientes
Mexico	Instituto Mexicano de Trasplantes	Cuernavaca
Mexico	Hospital Central Dr. Ignacio Morones Prieto	San Luis Potosi
United States	Albany Medical Cancer Center	Albany	New York
United States	Medical College of Georgia	Augusta	Georgia
United States	Tufts Medical Center	Boston	Massachusetts
United States	University at Buffalo	Buffalo	New York
United States	National Institute of Transplantation	Los Angeles	California
United States	University of California Los Angeles (UCLA)	Los Angeles	California
United States	University of Minnesota	Minneapolis	Minnesota
United States	Drexel University Department of Nephrology	Philadelphia	Pennsylvania
United States	Oregan Health & Science Univ	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Methodist Healthcare System of San Antonio	San Antonio	Texas
United States	University of California at San Francisco	San Francisco	California
United States	Western New England Renal & Transplant Associates, P.C.	Springfield	Massachusetts
United States	Stony Brook University Hospital	Stony Brook	New York
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline, EOT (Week 28)
Secondary	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.	Baseline, EOT (Week 28), end of FU (Week 52)
Secondary	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.	EOT (Week 28), end of FU (Week 52)
Secondary	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).	Baseline, EOT (Week 28), end of FU (Week 52)
Secondary	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).	EOT (Week 28), end of FU (Week 52)
Secondary	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).	EOT (Week 28), end of FU (Week 52)
Secondary	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).	Baseline, end of FU (Week 52)
Secondary	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).	Baseline, EOT (Week 28), end of FU (Week 52)
Secondary	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).	EOT (Week 28), end of FU (Week 52)
Secondary	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.	Baseline, EOT (Week 28), end of FU (Week 52)
Secondary	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.	EOT (Week 28), end of FU (Week 52)
Secondary	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.	Baseline, EOT (Week 28), end of FU (Week 52)
Secondary	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.	EOT (Week 28), end of FU (Week 52)
Secondary	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.	Baseline, EOT (Week 28), end of FU (Week 52)
Secondary	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.	EOT (Week 28), end of FU (Week 52)
Secondary	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.	Baseline, EOT (Week 28), end of FU (Week 52)
Secondary	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.	EOT (Week 28), end of FU (Week 52)
Secondary	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.	Baseline, EOT (Week 28), end of FU (Week 52)
Secondary	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.	EOT (Week 28), end of FU (Week 52)
Secondary	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.	Baseline, EOT (Week 28), end of FU (Week 52)
Secondary	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.	EOT (Week 28), end of FU (Week 52)
Secondary	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.	Baseline, EOT (Week 28), end of FU (Week 52)
Secondary	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.	EOT (Week 28), end of FU (Week 52)
Secondary	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.	Baseline, EOT (Week 28), end of FU (Week 52)
Secondary	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.	EOT (Week 28), end of FU (Week 52)
Secondary	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.	Baseline, EOT (Week 28), end of FU (Week 52)
Secondary	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.	EOT (Week 28), end of FU (Week 52)