NCT01663740

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_4

Geographic Reach
2 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2016

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

August 31, 2018

Completed
Last Updated

August 31, 2018

Status Verified

July 1, 2018

Enrollment Period

3.7 years

First QC Date

August 9, 2012

Results QC Date

October 2, 2017

Last Update Submit

August 1, 2018

Conditions

Cytomegalovirus Infections

Outcome Measures

Primary Outcomes (1)

  • 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 (26)

  • Change in Terminal Uridine Nick-End Labeling (TUNEL) Score From Baseline to EOT and End of Follow-up (FU)

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

  • Change in TUNEL Score From EOT to End of FU

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

  • Change in Seminal Volume From Baseline to EOT and End of FU

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

  • Change in Seminal Volume From EOT to End FU

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

  • Change in Sperm Density From EOT to End of FU

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

  • +21 more secondary outcomes

Study Arms (2)

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

ValganciclovirDRUG

Participants will receive valganciclovir 900 milligrams (mg) orally once daily for up to a maximum of 200 days post-transplant.

Also known as: Valcyte®
Cohort A: Partcipants who Received Valganciclovir

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

National Institute of Transplantation

Los Angeles, California, 90057, United States

Location

University of California Los Angeles (UCLA)

Los Angeles, California, 90095, United States

Location

University of California at San Francisco

San Francisco, California, 94115, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Western New England Renal & Transplant Associates, P.C.

Springfield, Massachusetts, 01107, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55902, United States

Location

Albany Medical Cancer Center

Albany, New York, 12208, United States

Location

University at Buffalo

Buffalo, New York, 14203, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Oregan Health & Science Univ

Portland, Oregon, 97237, United States

Location

Drexel University Department of Nephrology

Philadelphia, Pennsylvania, 19102, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Methodist Healthcare System of San Antonio

San Antonio, Texas, 78229, United States

Location

Hospital Miguel Hidalgo

Aguascalientes, 20230, Mexico

Location

Instituto Mexicano de Trasplantes

Cuernavaca, 62448, Mexico

Location

Hospital Central Dr. Ignacio Morones Prieto

San Luis Potosí City, 78240, Mexico

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Valganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

GanciclovirAcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
genentech@druginfo.com
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2012

First Posted

August 13, 2012

Study Start

January 30, 2012

Primary Completion

September 29, 2015

Study Completion

December 30, 2016

Last Updated

August 31, 2018

Results First Posted

August 31, 2018

Record last verified: 2018-07

Locations

US(16)ME(3)