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NCT00034385 · ClinicalTrials.gov registry record · Phase 4
Valganciclovir to Prevent Cytomegalovirus Infection in Kidney and Kidney/Pancreas Transplant Recipients
A Phase 4 study of Kidney Trasplant, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT00034385 is a Phase 4 study of Kidney Trasplant that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 12 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00034385, a Phase 4 study of Kidney Trasplant, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will compare different ways of giving the drugs ganciclovir and valganciclovir to kidney or kidney and pancreas transplant recipients to determine the most effective dose of valganciclovir for protecting against cytomegalovirus (CMV) infection in these patients. One of the most common viral infections following organ transplant, CMV can cause serious illness and even death. Ganciclovir reduces the incidence of CMV disease after kidney transplantation. The drug is given either intravenously (through a vein) twice a day or by mouth 3 times a day. Valganciclovir is converted to ganciclovir in the body and is absorbed into the bloodstream better than oral ganciclovir. In most transplant patients, a single daily dose of valganciclovir prevents CMV. Because of these advantages, some transplant patients are being given valganciclovir instead of ganciclovir to prevent CMV infection. However, the drug has not been studied in kidney and kidney transplant patients. This study will provide dosing information for this patient population. Patients 18 years of age and older who have had a kidney or kidney and pancreas transplant at the NIH Clinical Center may be eligible for this study. Participants will undergo the following treatments and procedures: \- Phase 1 - Treatment with intravenous ganciclovir for at least 7 days after transplantation. Sometime before starting phase 2, patients will provide a 24-hour urine collection to test for kidney function. The day before starting phase 2, they will have a cannula (small needle) inserted into an arm vein for about 12 hours to draw blood samples-one before starting the ganciclovir infusion, then at 15, 30, 60, and 90 minutes, and 2, 4, 6, 8, and 12 hours after the dose. * Phase 2 - Treatment with oral valganciclovir once a day for 7 to 21 days at a dose approximately equivalent to intravenous ganciclovir. Sometime between 4 and 21 days on this dose, patients will have blood sampling in the morning before taking the dr
Conditions Studied
Interventions
- DRUG Valganciclovir
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2002-04-24 |
| Est. Completion | 2009-10-30 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00034385
The ClinicalTrials.gov registry entry for NCT00034385 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Kidney Trasplant appearing as the primary indexed condition, and to 1 intervention - of which Valganciclovir is the first listed.
NCT00034385 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00034385 about?
NCT00034385 is a clinical study titled "Valganciclovir to Prevent Cytomegalovirus Infection in Kidney and Kidney/Pancreas Transplant Recipients". This study will compare different ways of giving the drugs ganciclovir and valganciclovir to kidney or kidney and pancreas transplant recipients to determine the most effective dose of valganciclovir for protecting against cytomegalovirus (CMV) infection in these patients. One of the most common vir...
What is the current status of trial NCT00034385?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2002-04-24. Estimated completion is 2009-10-30.
What conditions does trial NCT00034385 study?
This clinical trial studies the following conditions: Kidney Trasplant.
What interventions are being tested in trial NCT00034385?
The interventions under investigation include: Valganciclovir (DRUG).
Who is sponsoring clinical trial NCT00034385?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00034385 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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