Phase 4
N=59
A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls
Cytomegalovirus Infections
Bottom Line
View on ClinicalTrials.gov: NCT01663740 ↗Enrolled (actual)
59
Serious AEs
42.3%
Results posted
Aug 2018
Primary outcome: Primary: Change in Sperm Density From Baseline to the End of Treatment (EOT) — -9.770; 30.396 mil/mL — p=0.0075
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Valganciclovir (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Male
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Sperm Density From Baseline to the End of Treatment (EOT) |
-9.770; 30.396 | 0.0075 sig |
| SECONDARY Change in Terminal Uridine Nick-End Labeling (TUNEL) Score From Baseline to EOT and End of Follow-up (FU) |
-3.595; -5.354; -4.516; -3.465 | 0.5109 |
| SECONDARY Change in TUNEL Score From EOT to End of FU |
4.447; 1.578 | 0.3940 |
| SECONDARY Change in Seminal Volume From Baseline to EOT and End of FU |
-0.193; -0.347; -0.289; -0.161 | 0.6773 |
| SECONDARY Change in Seminal Volume From EOT to End FU |
-0.103; 0.024 | 0.7323 |
| SECONDARY Change in Sperm Density From EOT to End of FU |
57.149; 5.882 | 0.1756 |
| SECONDARY Change in Sperm Density From Baseline to End of FU |
39.671; 49.866 | 0.6058 |
| SECONDARY Change in Total Motility of Sperm From Baseline to EOT and End of FU |
3.839; 25.667; 24.736; 34.538 | 0.0222 sig |
| SECONDARY Change in Total Motility of Sperm From EOT to End of FU |
8.953; 20.635 | 0.3505 |
| SECONDARY Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From Baseline to EOT and End of FU |
3.720; 9.461; 5.128; 6.982 | 0.4021 |
| SECONDARY Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From EOT to End of FU |
-0.714; 2.236 | 0.7080 |
| SECONDARY Change in Total Testosterone Level From Baseline to EOT and End of FU |
0.762; 2.623; 0.395; 1.509 | 0.2673 |
| SECONDARY Change in Total Testosterone Level From EOT to End of FU |
-0.936; -0.984 | 0.9753 |
| SECONDARY Change in LH Level From Baseline to EOT and End of FU |
-0.281; -0.357; -1.857; -0.642 | 0.9053 |
| SECONDARY Change in LH Level From EOT to End of FU |
-1.482; -0.417 | 0.0143 sig |
| SECONDARY Change in FSH Level From Baseline to EOT and End of FU |
1.521; -1.020; -2.905; -1.922 | 0.1505 |
| SECONDARY Change in FSH Level From EOT to End of FU |
-3.462; -1.988 | 0.0798 |
| SECONDARY Change in Prolactin Level From Baseline to EOT and End of FU |
15.590; 15.693; 9.829; -5.443 | 0.9965 |
| SECONDARY Change in Prolactin Level From EOT to End of FU |
-7.429; -16.169 | 0.6134 |
| SECONDARY Change in Inhibin B Level From Baseline to EOT and End of FU |
5.075; -3.067; 51.416; 10.734 | 0.5002 |
| SECONDARY Change in Inhibin B Level From EOT to End of FU |
40.329; 14.448 | 0.2548 |
| SECONDARY Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From Baseline to EOT and End of FU |
50.0; 35.7; 25.0; 20.0; 25.0; 7.1 | — |
| SECONDARY Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From EOT to End of FU |
26.3; 22.2; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Improved TUNEL Score From Baseline to EOT and End of FU |
72.7; 71.4; 66.7; 60.0 | — |
| SECONDARY Percentage of Participants With Improved TUNEL Score From EOT to End of FU |
43.8; 55.6 | — |
| SECONDARY Percentage of Participants With Improved Sperm Density From Baseline to EOT and End of FU |
33.3; 64.3; 90.0; 80.0 | — |
| SECONDARY Percentage of Participants With Improved Sperm Density From EOT to End of FU |
78.9; 88.9 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01663740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.