drugset / Trial / NCT01663740
A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls
RandomizedOpen-labelOther
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.
Timeline
- Start
- 2012-01-30
- Primary completion
- 2015-09-29
- Completion
- 2016-12-30
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Cohort A: Partcipants Who Received Valganciclovir vs Cohort B: Untreated Participants; p = 0.0075; Mean Difference -40.166 (95% CI -68.869 to -11.463); Mixed Models Analysis NCT01663740 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Valganciclovir | Small molecule | 900 mg | Oral |