Prevention of cytomegalovirus (CMV) disease in kidney transplant recipients MedDRA version: 16.1 Level: PT Classification code 10023439 Term: Kidney transplant rejection System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Trade Name: Valcyte
Product Name: Valganciclovir
Product Code: Ro 107-9070
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Valganciclovir Hydrocloride
CAS Number: 175865-59-5
Current Spon
Sponsors
Roche Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient has received within the preceding 14 days a primary or secondary renal allograft from a liv-ing or cadaveric donor 2. Patient is IgG seropositive for CMV and has re-ceived an allograft from a CMV IgG seropositive or seronegative donor 3. Patient receives immunosuppression including a CNI (CsA or tacrolimus) and MMF (mycophe-nolate mofetil) 4. Patient is 18 years of age or older 5. Patient is willing to give written informed con-sent, written consent for data protection and will-ingness to participate and to comply with the study 6. Laboratory parameters: Patient has adequate he-matological and renal function defined as: a) Leucocyte count >3,500 cells/?L b) Platelet count >100,000 cells/?L c) Hemoglobin >8.0 g/dL d) Estimated creatinine clearance (calculated by the Cockcroft-Gault formula, see Section 6.1.2) of >10 ml/min with evidence of im-proving renal function 7. Patient agrees to utilize contraceptive methods throughout the study period and for 90 days fol-lowing discontinuation of the Study Drug. Male patients must agree to use condoms throughout the study period and for 90 days following discon-tinuation of the Study Drug. 8. Females of childbearing potential will have a negative pregnancy test at screening 9. Patient is able to tolerate oral medication within 14 days post transplantation. The day of comple-tion of transplant surgery is defined as Day 0 post transplantation. Are the trial subjects under 18? no 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
Exclusion criteria: 1. Patient has active CMV infection (CMV PCR = 400 copies/ml) 2. Severe uncontrolled diarrhea or evidence of malab-sorbtion 3. Patients with malignancies or history of malig-nancy except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully 4. Acute steroid resistant rejection episode since transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1a. Incidence of active CMV infection 1b. Incidence of CMV syndrome 1c. Incidence of CMV tissue invasive disease 2. Time to CMV infection 3. Viral burden at CMV infection 4. Renal function 5. Incidence of acute rejection 6. Cost analysis 7. Incidence of leucopenia and neutropenia 8. Incidence of opportunistic infections 9. Patient survival 10. Graft survival 11. Incidence of post transplant diabetes mellitus ;Main Objective: To determine the incidence of CMV disease and corresponding renal graft alteration;Primary end point(s): 1. Proportion of patients with CMV disease within 12 months including CMV syndrome and tissue invasive disease 2. Proportion of patients who exhibit a specific urine proteomic pattern at month 12 comparing the two treatment groups | — |
Countries
Austria, Germany
Outcome results
None listed