Immunosuppressive Effects of Mycophenolate Mofetil and Valganciclovir in Kidney Transplant Recipients
Public ClinicalTrials.gov record NCT00198224. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Pilot Study of In Vitro Immunosuppressive Effects of Mycophenolate Mofetil and Valganciclovir in Kidney Transplant Recipients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00198224
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2003 (Type not available)
- Primary completion
- Not listed
- Completion
- May 2005 (Type not available)
- Last update posted
- Sep 20, 2005
2003 – 2005
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Indiana University Hospital and Emerson Hall, Indiana University School of Medicine | Indianapolis | Indiana | 46202 | — |
| University Hospital | Indianapolis | Indiana | 46202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00198224, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 20, 2005 · Synced Nov 9, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00198224 live on ClinicalTrials.gov.