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

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2005-002817-19-GB
• Date of registration: 29/11/2005
• Prospective Registration: Yes
• Primary sponsor: F Hoffmann-La Roche Ltd
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 20/01/2006
• 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: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: yes; Other specify the comparator: Valganciclovir
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Germany, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
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

Exclusion criteria:
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)



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

Health Condition(s) or Problem(s) studied

Prevention of cytomegalovirus (CMV) disease in kidney transplant recipients

Intervention(s)

Product Name: Valganciclovir
Product Code: Ro 107-9070
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

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

Main Objective: 1. 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.

2. 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) when given for the prevention of CMV disease in high risk (D+/R-) kidney allograft recipients.

Secondary Objective: 1. Time to CMV disease
2. Proportion of patients with CMV disease
3. Proportion of patients with CMV viraemia
4. Time to CMV viremia
5. Proportion of patients experiencing biopsy proven acute rejection (BPAR)
6. Proportion of patients with graft loss
7. Proportion of patients surviving
8. Proportion of patients with opportunistic infections
9. Proportion of patients with seroconversion
10. Time to seroconversion
11. Proportion of patients with CMV harbouring genotypic changes associated with the development of CMV resistance to ganciclovir
13. Proportion of patients experiencing post-transplant diabetes mellitus

Secondary ID(s)

2005-002817-19-BE

NT18435

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 22/05/2015
• Date Completed: 13/08/2009
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-002817-19/results