A Randomized, Double-Blind, Placebo Controlled Multi-Center Study of the Efficacy and Safety of up to 100 days of Valganciclovir vs. up to 200 days of Valganciclovir for Prevention of Cytomegalovirus Disease in High-Risk Kidney Allograft Recipients - ND

ROCHE0 sites316 target enrollmentStarted: January 3, 2006Last updated: April 18, 2012

Conditions

Drugs

Trial Snapshot

Phase: Not Applicable
Status: Active, not recruiting
Sponsor: ROCHE
Enrollment: 316

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional clinical trial of medicinal product

Eligibility Criteria

Sex: All

Inclusion Criteria

•1. Patient has received his/her first or second live or cadaveric kidney allograft. 2. Patient is seronegative for CMV confirmed within 30 days pre-transplant and has received an allograft from a CMV seropositive donor. A donor who is seropositive solely based on having received a CMV seropositive transfusion immediately prior to organ donation is not considered to be a seropositive donor in this study. 3. Patient is 16 years of age or older. 4. Patient has adequate hematological and renal function post-transplant defined as a Absolute neutrophil count ANC 1000 cells/ L. b Platelet count 25,000 cells/ L. c Hemoglobin 8.0 g/dL. d Estimated creatinine clearance calculated by the Cockcroft-Gault formula of 15 mL/min with evidence of improving renal function. 5. Females of childbearing potential must have a negative pregnancy test at screening. 6. Female patients of, and male patients with partners of, child bearing potential agree to maintain effective birth control for 90 days following cessation of study medication normally week 40 post-transplant . Male patients should be advised to practice barrier contraception during and for at least 90 days following cessation of study medication. 7. Patient is able to tolerate and commence oral medication within 10 days post transplantation. The day of completion of transplant surgery is defined as Day 0. 8. Patient understands and signs the Informed Consent.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•1. Patient is suspected of having CMV disease. 2. Patient has received anti-CMV therapy within the past 30 days prior to screening. Acyclovir, valacyclovir, or famciclovir may be used for up to 10 days, at the dose specified in the package insert, for treatment of acute Herpes Simplex or Herpes Zoster. 3. Patient is receiving a multi organ transplant e.g. liver or pancreas in addition to kidney . 4. Patient has received an investigational new drug within the past 30 days, except as approved by Roche Medical Science Representative. 5. Patient is simultaneously participating in another clinical trial except as approved by a Roche Medical Science Representative. 6. Patient has severe, uncontrolled diarrhea multiple watery stools or evidence of malabsorption. 7. Patient has exhibited in the past an allergic or other significant adverse reaction to acyclovir, valacyclovir, ganciclovir, or valganciclovir. 8. Patient requires the use of any prohibited concomitant medications. 9. Patient is a lactating female who will not discontinue nursing prior to study entry. 10. Patient has liver function test results greater than 3 times the upper limit of normal ULN . 11. Patient is known to be positive for Human Immunodeficiency Virus HIV , Hepatitis B HBV; HBs Ag positive or Hepatitis C HCV; anti-HCV Ab positive . 12. Patients with malignancies or history of malignancy except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully. TARGET POPULATION Cont. 13. Male patients with a pregnant partner. 14. Patients with any form of substance abuse, psychiatric disorder or serious medical condition which, in the opinion of the Investigator, may lead to non compliance, invalidate communication with the Investigator or lead to complexity in patient management e.g. epilepsy, manic depression etc 15. Patient is unlikely to be available for follow-up for the full duration of the study 104 weeks .

Investigators

Sponsor

ROCHE

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