Valganciclovir to Prevent Cytomegalovirus Infection in Kidney and Kidney/Pancreas Transplant Recipients

NCT00034385 | Completed Phase 4

• 2 other identifiers: 02016802-CC-0168
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Kidney Trasplant

Keywords

Cytomegalovirus; Prophylaxis; Renal Transplant; Valcyte; Kidney Transplant

Interventions

Valganciclovir DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Fishman JA, Rubin RH. Infection in organ-transplant recipients. N Engl J Med. 1998 Jun 11;338(24):1741-51. doi: 10.1056/NEJM199806113382407. No abstract available.

  PMID: 9624195 BACKGROUND

• Rubin RH. The indirect effects of cytomegalovirus infection on the outcome of organ transplantation. JAMA. 1989 Jun 23-30;261(24):3607-9. No abstract available.

  PMID: 2542634 BACKGROUND

• 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. doi: 10.1097/00007890-199605150-00001. No abstract available.

  PMID: 8629285 BACKGROUND

MeSH Terms

Interventions

Valganciclovir

Intervention Hierarchy (Ancestors)

Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: April 29, 2002
• Study Start: April 24, 2002
• Primary Completion: January 30, 2007
• Study Completion: October 30, 2009
• Last Updated: July 2, 2017

Record last verified: 2008-08-20

Locations

US (1)