Treating Kidney Donors With Valganciclovir to Reduce Viral Transmission to Recipients

NCT01329185 | Completed Phase 2 Results

• 1 other identifier: 1012M93572
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to reduce viral (CMV and EBV) transmission from donor to recipient. The discovery that anti-retroviral therapy to mothers with HIV reduced transmission of the virus to their babies was pivotal to the prevention of AIDS and so along the same lines the investigators will test the hypothesis that 14 days of the anti-viral Valganciclovir (VAL) to kidney donors prior to the transplant compared to placebo will reduce EBV and CMV viremia in the 1st year posttransplant in pediatric kidney recipients.

Conditions

EBV Viremia; CMV Viremia

Keywords

EBV Viremia in posttransplant kidney recipients; CMV viremia in posttransplant kidney recipients

Outcome Measures

Primary Outcomes (1)

• Incidence of EBV or CMV Related Disease in Transplant Recipient

  Incidence of EBV or CMV related disease in the transplant recipients of enrolled donors.

  At least 1 year

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date

Drug: Placebo

Valganciclovir

EXPERIMENTAL

Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date

Drug: Valganciclovir

Interventions

Valganciclovir DRUG

Valganciclovir 450mg twice a day for 14 days prior to transplant date

Valganciclovir

Placebo DRUG

1 capsule twice a day for 14 days prior to transplant date

Placebo

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any person approved as a kidney transplant donor with a recipient who has never undergone a previous transplantation
• Kidney transplant donor must be 18 years old or older
• The kidney transplant donor must be positive for CMV IgG and / or EBV IgG
• The donor must be to a recipient that is discordantly seronegative for the virus for which the donor is seropositive (D+ R-)
• They must have provided signed informed consent
• The potential donors must be willing to contribute samples of blood and oral washings at regular intervals
• The potential donor must state willingness to use effective contraception during treatment and 30 days following receiving the study drug/placebo
• All females must have a negative pregnancy test
• Person must have estimated creatinine clearance (Cockcroft and Gault method) \>= 60 ml/min
• Person must have Absolute neutrophil count \>= 1000 cells/uL
• Person must have Platelets \>= 100,000/uL
• Person must have Hemoglobin \>= 9.5 g/dL

You may not qualify if:

• Any potential kidney transplant donor who is seronegative for both CMV \& EBV IgG
• Any potential kidney transplant donor who is receiving or have received anti-herpes medication in the past week
• Any potential kidney transplant donor to a recipient who has received a previous solid organ transplant
• Any potential kidney transplant donor who is immunosuppressed due to medical disease and/or immunosuppressive or immunomodulating medications
• Any potential kidney transplant donor who is breast feeding during the study
• Any potential kidney transplant donor who is on corticosteroids

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (2)

• Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.

  PMID: 38700045 DERIVED

• Verghese PS, Evans MD, Hanson A, Hathi J, Chinnakotla S, Matas A, Balfour HH Jr. Valacyclovir or valganciclovir for cytomegalovirus prophylaxis: A randomized controlled trial in adult and pediatric kidney transplant recipients. J Clin Virol. 2024 Jun;172:105678. doi: 10.1016/j.jcv.2024.105678. Epub 2024 Apr 22.

  PMID: 38688164 DERIVED

MeSH Terms

Interventions

Valganciclovir

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Study was unblinded 2 months following the enrollment of the final donor, when a recipient developed post-transplant lymphoproliferative disorder with evidence of EBV infection at the single cell level by detection of EBV encoded small nuclear RNA.

Results Point of Contact

• Title: Dr. Priya Verghese, Director of Pediatric Kidney Transplantation
• Organization: University of Minnesota

pverghes@umn.edu

6126262922

Study Officials

• Priya Verghese, MD, MPH

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: April 5, 2011
• Study Start: June 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: November 1, 2019
• Results First Posted: June 20, 2014

Record last verified: 2019-10

Locations

US (1)