Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 71 of 101 for:    Valcyte

Immunosuppressive Effects of Mycophenolate Mofetil and Valganciclovir in Kidney Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00198224
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : September 20, 2005
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Indiana University

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.


Condition or disease Intervention/treatment Phase
Renal Failure Procedure: phlebotomy Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study of In Vitro Immunosuppressive Effects of Mycophenolate Mofetil and Valganciclovir in Kidney Transplant Recipients
Study Start Date : January 2003
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. >18 years of age
  2. Primary kidney transplant
  3. MMF included as part of baseline immunosuppression
  4. On valganciclovir for CMV prophylaxis. The dose will vary based on renal function but the standard dose is 900 mg per day
  5. No prior episodes of rejection
  6. On a stable dose of immunosuppressive medications -

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198224


Locations
Layout table for location information
United States, Indiana
Indiana University Hospital and Emerson Hall, Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Hoffmann-La Roche
Investigators
Layout table for investigator information
Principal Investigator: Mark D Pescovitz, MD Indiana University School of Medicine

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00198224     History of Changes
Other Study ID Numbers: 0212-78
VAL074
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: September 20, 2005
Last Verified: November 2004

Keywords provided by Indiana University:
immunosuppression

Additional relevant MeSH terms:
Layout table for MeSH terms
Valganciclovir
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Mycophenolic Acid
Immunosuppressive Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents