NCT00198224

Brief Summary

Valganciclovir (VGCV) has recently been approved by the Food and Drug Administration (FDA) for the treatment and prevention of cytomegalovirus (CMV) retinitis in HIV patients. It is under review for the prevention of CMV disease following organ transplantation. Mycophenolate mofetil (MMF), the morpholinoethyl ester of mycophenolic acid (MPA) is currently the most widespread used immunosuppressant in kidney transplantation. These drugs exerts their effects by blocking the production of DNA primarily in lymphocytes. Recent studies have suggested that combining both MMF and GCV in vitro may have a beneficial effect on the treatment of CMV infections. However, the effect of these two drugs in combination on the effects of the immune system both in vitro and in vivo have not been studied. Preliminary studies in our lab show that a combination of these two drugs have an additive effect on the level of immunosuppression of both the growth and differentiation of progenitor bone marrow cells as well as lymphocyte proliferation. This study is designed to test patients degree of immune reactivity both on and off VGCV when used in combination with MMF. Patients will have blood drawn as several time points and an immune assay will be performed to show if VGCV when used in combination with MMF exerts immunosuppressive effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2003

Typical duration for not_applicable

Geographic Reach
1 country

2 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 1, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

September 20, 2005

Status Verified

November 1, 2004

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

Renal Failure

Keywords

immunosuppression

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint of this study is the analysis of immune responsiveness in vitro in patients before and after routine cessation of VGCV.

Secondary Outcomes (1)

  • Secondary endpoints of this study are the analysis of absolute neutrophil count before and after routine cessation of VGCV. This will be obtained from the patient's complete blood count and differential.

Interventions

phlebotomyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years of age
  • Primary kidney transplant
  • MMF included as part of baseline immunosuppression
  • On valganciclovir for CMV prophylaxis. The dose will vary based on renal function but the standard dose is 900 mg per day
  • No prior episodes of rejection
  • On a stable dose of immunosuppressive medications -

You may not qualify if:

  • Previous or multiple transplant patients (e.g. second kidney or simultaneous kidney pancreas patient)
  • Uncontrolled or recurrent infections.
  • Psychiatric disorder -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indiana University Hospital and Emerson Hall, Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

University Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Mark D Pescovitz, MD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

January 1, 2003

Study Completion

May 1, 2005

Last Updated

September 20, 2005

Record last verified: 2004-11

Locations

US(2)