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NCT01663740 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 4
Development phase
59
Enrollment target

NCT01663740: Completed Phase 4 study, sponsored by Hoffmann-La Roche.

NCT01663740 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 59 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01663740, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 4
Development phase
59 participants
Enrollment target

Study 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.

Primary Outcome

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).

Interventions

  • DRUG Valganciclovir

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2012-01-30
Est. Completion 2016-12-30
Phase Phase 4
Hoffmann-La Roche

909 total trials

What the finished NCT01663740 record still lists

NCT01663740 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 1 intervention - of which Valganciclovir is the first listed.

NCT01663740 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01663740 about?

NCT01663740 is a clinical study titled "A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls". 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.

What is the current status of trial NCT01663740?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 59 participants. The study started on 2012-01-30. Estimated completion is 2016-12-30.

What interventions are being tested in trial NCT01663740?

The interventions under investigation include: Valganciclovir (DRUG).

Who is sponsoring clinical trial NCT01663740?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01663740's enrollment target sits among peer trials

59 1202nd of 2000 higher than 796 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01663740, the US trial registry maintained by the National Library of Medicine. NCT01663740 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.