drugset / Trial / NCT01663740

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

NCT01663740 ↗

Phase 4 Completed 59 enrolled Hoffmann-La Roche
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

EvaluationDrugModalityDoseRoute
Subject Valganciclovir Small molecule 900 mg Oral