A Study on Spermatogenesis in Male Renal Transplant Recip... | NCT01663740

NCT01663740

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort A: Partcipants who Received Valganciclovir	Experimental	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
Cohort B: Untreated Participants	No Intervention	Participants with donor negative (D-)/R- CMV serology, who do not receive prophylaxis, will be observed for spermatogenesis up to 52 weeks post-transplant.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Valganciclovir	Drug	Participants will receive valganciclovir 900 milligrams (mg) orally once daily for up to a maximum of 200 days post-transplant.	Cohort A: Partcipants who Received Valganciclovir

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
National Institute of Transplantation		Los Angeles	California	90057	United States
University of California Los Angeles (UCLA)

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with donor positive (D+)/recipient negative (R-) cytomegalovirus (CMV) serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

FG00038 subjectsSafety Population

FG00121 subjectsSafety Population

Safety population included all participants assigned to a cohort. One participant who was considered for inclusion in the study but did not participate, was excluded from baseline analysis.

Arm/Group Information

ID	Title	Description
BG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
BG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG000-9.770± 9.0518 OG00130.396± 11.3044

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis	Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,& duration of pre-transplant dialysis as explanatory variables.	0.0075		Mean Difference	-40.166	Standard Error of the Mean	14.1387	2-Sided	95	-68.869	-11.463			Change in sperm density from Baseline to EOT		Superiority or Other

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.

Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.

Posted

Mean

Standard Error

percent score

Baseline, EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

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.

Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Error

percent score

EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts
Participants

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).

Posted

Mean

Standard Error

Baseline, EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts

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).

Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Error

EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts
Participants

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).

Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Error

mil/mL

EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts
Participants

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).

Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Error

mil/mL

Baseline, end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts
Participants

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).

Posted

Mean

Standard Error

percent motility

Baseline, EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

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).

Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Error

percent motility

EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts
Participants

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.

Posted

Mean

Standard Error

percentage of normal sperm cells

Baseline, EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units

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.

Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Error

percentage of normal sperm cells

EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts
Participants

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.

Posted

Mean

Standard Error

nmol/L

Baseline, EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts

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.

Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Error

nmol/L

EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts
Participants

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.

Posted

Mean

Standard Error

mU/mL

Baseline, EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts
Participants

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.

Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Error

mU/mL

EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Error

U/L

Baseline, EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts
Participants

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.

Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Error

U/L

EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts
Participants

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.

Posted

Mean

Standard Error

mU/mL

Baseline, EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts
Participants

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.

Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Error

mU/mL

EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts
Participants

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.

Posted

Mean

Standard Error

pg/mL

Baseline, EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts
Participants

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.

Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Error

pg/mL

EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts
Participants

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.

Posted

Number

percentage of participants

Baseline, EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts
Participants

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.

Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Number

percentage of participants

EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts
Participants

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.

Posted

Number

percentage of participants

Baseline, EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts
Participants

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.

Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Number

percentage of participants

EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts
Participants

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.

Posted

Number

percentage of participants

Baseline, EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts
Participants

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.

Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Number

percentage of participants

EOT (Week 28), end of FU (Week 52)

ID	Title	Description
OG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
OG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort A: Partcipants Who Received Valganciclovir	Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.			10	31	24	31
EG001	Cohort B: Untreated Participants	Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.			12	21	19	21

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Transplant rejection	Immune system disorders	MedDRA 19.1	Non-systematic Assessment	EG0003 affected31 at risk EG0011 affected21 at risk
Kidney transplant rejection	Immune system disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected21 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected21 at risk
Atypical pneumonia	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected21 at risk
Gastroenteritis	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected21 at risk
Pyelonephritis	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected21 at risk
Sinusitis	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected21 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 19.1	Non-systematic Assessment	EG0003 affected31 at risk EG0011 affected21 at risk
Hematuria	Renal and urinary disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected21 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected21 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected21 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected21 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected21 at risk
Rectal hemorrhage	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected21 at risk
Retroperitoneal hematoma	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected21 at risk
Blood creatinine increased	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0000 affected31 at risk EG0013 affected21 at risk
Death	General disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected21 at risk
Pyrexia	General disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected21 at risk
Foreign body	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected21 at risk
Perinephric collection	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected21 at risk
Fetal death	Pregnancy, puerperium and perinatal conditions	MedDRA 19.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected21 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected21 at risk
Treatment noncompliance	Social circumstances	MedDRA 19.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected21 at risk
Hypertension	Vascular disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected21 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Non-systematic Assessment	EG0007 affected31 at risk EG0015 affected21 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 19.1	Non-systematic Assessment	EG0006 affected31 at risk EG0014 affected21 at risk
Polycythaemia	Blood and lymphatic system disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected31 at risk EG0011 affected21 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0004 affected31 at risk EG00112 affected21 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0002 affected31 at risk EG0012 affected21 at risk
Incision site haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected21 at risk
Perinephric collection	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected21 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected21 at risk
Tremor	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0007 affected31 at risk EG0015 affected21 at risk
Headache	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0003 affected31 at risk EG0014 affected21 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected31 at risk EG0011 affected21 at risk
Paraesthesia	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected31 at risk EG0012 affected21 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0005 affected31 at risk EG0011 affected21 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0004 affected31 at risk EG0012 affected21 at risk
Constipation	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0003 affected31 at risk EG0012 affected21 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0004 affected31 at risk EG0011 affected21 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected31 at risk EG0013 affected21 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected21 at risk
Gastritis	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected21 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected21 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected21 at risk
Blood creatinine increased	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0006 affected31 at risk EG0014 affected21 at risk
Transaminases increased	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0005 affected31 at risk EG0012 affected21 at risk
Immunosuppressant drug level increased	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0000 affected31 at risk EG0014 affected21 at risk
Blood pressure increased	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0003 affected31 at risk EG0010 affected21 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 19.1	Non-systematic Assessment	EG0008 affected31 at risk EG0012 affected21 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 19.1	Non-systematic Assessment	EG0007 affected31 at risk EG0010 affected21 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 19.1	Non-systematic Assessment	EG0005 affected31 at risk EG0011 affected21 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 19.1	Non-systematic Assessment	EG0003 affected31 at risk EG0011 affected21 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected21 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected21 at risk
Haematuria	Renal and urinary disorders	MedDRA 19.1	Non-systematic Assessment	EG0004 affected31 at risk EG0015 affected21 at risk
Dysuria	Renal and urinary disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected31 at risk EG0014 affected21 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 19.1	Non-systematic Assessment	EG0003 affected31 at risk EG0010 affected21 at risk
Proteinuria	Renal and urinary disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected31 at risk EG0012 affected21 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0004 affected31 at risk EG0011 affected21 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 affected31 at risk EG0013 affected21 at risk
Escherichia infection	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0000 affected31 at risk EG0013 affected21 at risk
Staphylococcal infection	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected21 at risk
Pyrexia	General disorders	MedDRA 19.1	Non-systematic Assessment	EG0003 affected31 at risk EG0014 affected21 at risk
Oedema peripheral	General disorders	MedDRA 19.1	Non-systematic Assessment	EG0005 affected31 at risk EG0010 affected21 at risk
Fatigue	General disorders	MedDRA 19.1	Non-systematic Assessment	EG0004 affected31 at risk EG0010 affected21 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected31 at risk EG0013 affected21 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected31 at risk EG0013 affected21 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected31 at risk EG0011 affected21 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected21 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected31 at risk EG0013 affected21 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0003 affected31 at risk EG0010 affected21 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected31 at risk EG0012 affected21 at risk
Hypertension	Vascular disorders	MedDRA 19.1	Non-systematic Assessment	EG0003 affected31 at risk EG0013 affected21 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Non-systematic Assessment	EG0003 affected31 at risk EG0011 affected21 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected21 at risk
Insomnia	Psychiatric disorders	MedDRA 19.1	Non-systematic Assessment	EG0003 affected31 at risk EG0012 affected21 at risk
Transplant rejection	Immune system disorders	MedDRA 19.1	Non-systematic Assessment	EG0003 affected31 at risk EG0010 affected21 at risk
Tachycardia	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected21 at risk
Scrotal swelling	Reproductive system and breast disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected21 at risk
Wound drainage	Surgical and medical procedures	MedDRA 19.1	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected21 at risk

ID	Term
D003586	Cytomegalovirus Infections

ID	Term
D000077562	Valganciclovir

Ancestor Terms

ID	Term
D015774	Ganciclovir
D000212	Acyclovir
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Units	Counts
Participants	OG00022 OG00114

ID	Term
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections