Kidney Trasplant Clinical Trial
Official title:
Pharmacokinetics of Valganciclovir in Kidney and Kidney/Pancreas Transplant Recipients
| Verified date | August 20, 2008 |
| Source | National Institutes of Health Clinical Center (CC) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 0.5, 1, 1.5, 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 0.5, 1, 1.5, 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 0.5, 1, 1.5, 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.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | October 30, 2009 |
| Est. primary completion date | January 30, 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
- INCLUSION CRITERIA: Candidates receiving kidney or kidney/pancreas transplants at the Warren G. Magnuson Clinical Center who require CMV prophylaxis. Willingness and legal ability to give informed consent. Estimated creatinine clearance (using MDRD 4 variable equation (16)) of greater than or equal to 60ml/min/1.73m(2) or a 24 hour urine creatinine clearance of greater than or equal to 60ml/min/1.73m(2). EXCLUSION CRITERIA: Age less than 18 years old. Pregnant (pregnancy test as part of transplant protocol). Absolute neutrophil count less than 500/mm(3). Platelet count less than 50,000/mm(3). Severe anemia postoperatively, Hgb less than 8.0 mg/dl despite erythropoetin therapy (subjects can be started on erythropoetin and iron supplementation post transplant). Hypersensitivity to ganciclovir or valganciclovir. The presence of persistent diarrhea (greater than or equal to 7 stools or stool volume greater than 1 liter per day for greater than or equal to 3 days). |
| Country | Name | City | State |
|---|---|---|---|
| United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| National Institutes of Health Clinical Center (CC) |
United States,
Fishman JA, Rubin RH. Infection in organ-transplant recipients. N Engl J Med. 1998 Jun 11;338(24):1741-51. Review. — View Citation
Patel R, Snydman DR, Rubin RH, Ho M, Pescovitz M, Martin M, Paya CV. Cytomegalovirus prophylaxis in solid organ transplant recipients. Transplantation. 1996 May 15;61(9):1279-89. — View Citation
Rubin RH. The indirect effects of cytomegalovirus infection on the outcome of organ transplantation. JAMA. 1989 Jun 23-30;261(24):3607-9. Review. — View Citation