ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation

NCT01972035 | Completed Phase 2 Results DMC

• 1 other identifier: 130162
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

Our study will compare all kidney transplant recipients receiving valganciclovir vs. valacyclovir for one year following kidney transplant and compare:

1. 1.the incidence, magnitude and duration of CMV and EBV viremia in the first year after transplant.
2. 2.the side effects of the anti-viral drugs requiring dose reduction or cessation

Conditions

Transplantation Infection; Epstein-Barr Virus Infections; Cytomegalovirus Infections

Keywords

EBV; CMV; Kidney transplant; valganciclovir; valacyclovir

Outcome Measures

Primary Outcomes (1)

• Compare Incidence, Duration and Magnitude of CMV and EBV Viremia in Kidney Transplant Recipients Receiving valA vs. valG.

  In infectious mononucleosis intervention trials, two weeks of valA therapy resulted in a statistically significant reduction in oral EBV shedding, accompanied by a clinical benefit, and valA is currently used for the therapy of severe cases of infectious mononucleosis in the community. ValA has also been shown to reduce the incidence and delay the onset of CMV disease in both CMV seronegative patients (P\<0.001) and CMV seropositive patients (P=0.03). Therefore we hypothesize that the anti-EBV and anti-CMV effects of valA will be equal to or more effective than valG in reducing post-kidney transplant EBV and CMV viremia.

  First year post-kidney transplant

Study Arms (2)

ValAcyclovir

EXPERIMENTAL

Kidney recipients who give informed consent will be randomly assigned to receive ValA or ValG in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.

Drug: Valacyclovir

ValGanciclovir

ACTIVE COMPARATOR

Kidney recipients who give informed consent will be randomly assigned to receive ValG or ValA in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.

Drug: Valganciclovir

Interventions

Valacyclovir DRUG

Experimental Arm

Also known as: Valtrex, Valacyclovir Hydrochloride, Valacyclovir HCL

ValAcyclovir

Valganciclovir DRUG

Standard of care

Also known as: Valcyte, Valganciclovir hydrochloride

ValGanciclovir

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All consenting kidney transplant recipients.

You may not qualify if:

• Non-consent.
• Recipients with allergies to valacyclovir or valganciclovir
• Recipients that are unable to independently understand the consent form and do not have a legally authorized representative.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of MN

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (2)

• Kacer M, Kielberger L, Bouda M, Reischig T. Valganciclovir versus valacyclovir prophylaxis for prevention of cytomegalovirus: an economic perspective. Transpl Infect Dis. 2015 Jun;17(3):334-41. doi: 10.1111/tid.12383. Epub 2015 May 26.

  PMID: 25824586 BACKGROUND

• Reischig T, Kacer M, Jindra P, Hes O, Lysak D, Bouda M. Randomized trial of valganciclovir versus valacyclovir prophylaxis for prevention of cytomegalovirus in renal transplantation. Clin J Am Soc Nephrol. 2015 Feb 6;10(2):294-304. doi: 10.2215/CJN.07020714. Epub 2014 Nov 25.

  PMID: 25424991 BACKGROUND

MeSH Terms

Conditions

Epstein-Barr Virus Infections; Cytomegalovirus Infections

Interventions

Valacyclovir; Valganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ganciclovir

Results Point of Contact

• Title: Henry Balfour, MD
• Organization: University of Minnesota

balfo001@umn.edu

612-625-3998

Study Officials

• Hank Balfour, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 30, 2013
• Study Start: August 1, 2014
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: April 12, 2022
• Results First Posted: March 16, 2022

Record last verified: 2022-03

Locations

US (1)