Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034385
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Valganciclovir to Prevent Cytomegalovirus Infection in Kidney and KidneyPancreas Transplant Recipients
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pharmacokinetics of Valganciclovir in Kidney and KidneyPancreas Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2008-08-20
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 drug and then at 05 1 15 2 4 6 8 12 and 24 hours after the dose
Phase 3 - Treatment with valganciclovir at a dose reduced by half to approximate oral ganciclovir dosing
After at least 4 days on this dose patients will be admitted to the hospital for 1 day for blood sampling before the drug dose and then at 05 1 15 2 4 6 8 12 and 24 hours after the dose Kidney function will be assessed by blood tests within 2 days of the blood sampling If kidney function is not within the normal range further dosing and blood sampling will be delayed until kidney function returns to the normal range
- Phase 4 - Treatment with oral ganciclovir every 8 hours After at least 4 days on this regimen patients will be admitted to the hospital for 1 day for blood sampling before the drug dose and then at 05 1 15 2 4 6 and 8 hours after the dose Kidney function will be estimated by blood tests within 2 days of the blood sampling If kidney function is not within the normal range further dosing and blood sampling will be delayed until kidney function returns to normal range
After completing phase 4 patients will continue valganciclovir daily or oral ganciclovir treatment and blood sampling for a length of time prescribed by the transplant surgeon
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 drug and then at 05 1 15 2 4 6 8 12 and 24 hours after the dose
Phase 3 - Treatment with valganciclovir at a dose reduced by half to approximate oral ganciclovir dosing
After at least 4 days on this dose patients will be admitted to the hospital for 1 day for blood sampling before the drug dose and then at 05 1 15 2 4 6 8 12 and 24 hours after the dose Kidney function will be assessed by blood tests within 2 days of the blood sampling If kidney function is not within the normal range further dosing and blood sampling will be delayed until kidney function returns to the normal range
- Phase 4 - Treatment with oral ganciclovir every 8 hours After at least 4 days on this regimen patients will be admitted to the hospital for 1 day for blood sampling before the drug dose and then at 05 1 15 2 4 6 and 8 hours after the dose Kidney function will be estimated by blood tests within 2 days of the blood sampling If kidney function is not within the normal range further dosing and blood sampling will be delayed until kidney function returns to normal range
After completing phase 4 patients will continue valganciclovir daily or oral ganciclovir treatment and blood sampling for a length of time prescribed by the transplant surgeon
Detailed Description:
Cytomegalovirus in solid organ transplant recipients can result in significant morbidity and mortality due to concurrent immunosuppression Traditionally intravenous followed by oral ganciclovir has been used to prevent and treat cytomegalovirus infection and disease in transplant recipients Recently a new oral form of ganciclovir valganciclovir has been approved by the Food and Drug Administration for the treatment of CMV retinitis in patients with AIDS Valganciclovir is more bioavailable and requires fewer daily doses and lower pill burden than oral ganciclovir In addition valganciclovir can attain ganciclovir plasma levels similar to intravenous ganciclovir This protocol will test the ability of valganciclovir to provide similar drug exposure area under the curve AUC as oral and intravenous ganciclovir at equivalent doses in the setting of kidney and kidney-pancreas transplantation Patients will receive four different dosingdosage form schemes Intravenous ganciclovir at 25mgkg every 12 hours which is the usual treatment at this facility post surgery will be administered for approximately 7 days phase I then patients will receive valganciclovir 900 mg daily for 7 to 21 days phase II then patients will receive 450 mg daily for at least 4 days phase III and finally ganciclovir 1000 mg every 8 hours for at least 4 days phase IV Serial blood samples will be collected for pharmacokinetic analyses after each change in dosedosage form after each phase After completion of the study patients will be maintained on valganciclovir 450 mg daily for CMV prophylaxis or oral ganciclovir for a length of time prescribed by the transplant surgeon By characterizing the pharmacokinetics of valganciclovir in kidneypancreas transplant patients it is hoped that appropriate dosing to prevent CMV disease and limit toxicity may be achieved
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-CC-0168 | None | None | None |