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

• Register: EUCTR
• Last refreshed on: 18 April 2012
• Main ID: EUCTR2005-002817-19-IT
• Date of registration: 03/01/2006
• Prospective Registration: Yes
• Primary sponsor: ROCHE
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 30/05/2006
• Target sample size: 316
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002817-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: stesso farmaco, diversa durata di somministrazione

Countries of recruitment

Germany, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

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 .


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

CMV disease in high risk kidney transplant recipients
MedDRA version: 6.1 Level: PT Classification code 10011831

Intervention(s)

Trade Name: VALCYTE 60 CPR RIV. 450 MG
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Valganciclovir
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 450-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: To determine the comparative safety of up to 100 days valganciclovir 900 mg once daily prophylaxis relative to up to 200 days valganciclovir 900 mg once daily prophylaxis when given for the prevention of CMV disease in high-risk D /R- kidney allograft recipients.

Primary end point(s): The proportion of patients who develop CMV disease defined either CMV syndrome or tissue invasive CMV within the first 12 months post-transplant

Main Objective: To determine the comparative efficacy of up to 100 days valganciclovir 900 mg once daily prophylaxis relative to up to 200 days valganciclovir 900 mg once daily prophylaxis when given for the prevention of CMV disease in high-risk D /R- kidney allograft recipients. The primary endpoint of the study will be the proportion of patients who develop CMV disease within the first 52 weeks 12 months post-transplant.

Secondary ID(s)

NT 18435

2005-002817-19-GB