A randomised, double blind, placebo controlled multicentre 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
- Conditions
- Prevention of cytomegalovirus (CMV) disease in kidney transplant recipients
- Registration Number
- EUCTR2005-002817-19-BE
- Lead Sponsor
- F Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 316
1. Patient has received within the preceding ten days a primary or secondary renal allograft from a living or cadaveric donor.
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, see Section 6.1) of >15 mL/min with evidence of improving renal function.
5. Patient agrees to utilize contraceptive methods throughout the study period and for 90 days following discontinuation of the Study Drug.
6. Females of childbearing potential will have a negative pregnancy test at screening.
7. Patient is able to tolerate oral medication within 10 days post transplantation. The day of completion of transplant surgery is defined as Day 0 post transplantation.
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) yes
F.1.3.1 Number of subjects for this age range
1. Patient is suspected of having CMV disease.
2. Patient has received anti-CMV therapy within the past 30 days. (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 positive for HIV, Hepatitis B or Hepatitis C
12. Patient with malignancies or history of malignancy except non metastatic basal or squamous cell carcinoma of the skin that has been treated sucessfully
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 teh investigator or lead to complexity in patient management
15. Patient is unlikely to be available for follow-up for the full duration of the study (104 weeks)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method