Trial comparing Valganciclovir CMV prophylaxis versus pre-emptive therapy after renal transplantation using proteomics for monitoring of graft alteratio

• Conditions: Prevention of cytomegalovirus (CMV) disease in kidney transplant recipients; MedDRA version: 17.0Level: PTClassification code 10023439Term: Kidney transplant rejectionSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2005-004695-20-AT
• Lead Sponsor: Roche Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-19
• Last Update Posted: 11 January 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: 1a. Incidence of active CMV infection<br>1b. Incidence of CMV syndrome<br>1c. Incidence of CMV tissue invasive disease<br>2. Time to CMV infection<br>3. Viral burden at CMV infection<br>4. Renal function<br>5. Incidence of acute rejection<br>6. Cost analysis<br>7. Incidence of leucopenia and neutropenia<br>8. Incidence of opportunistic infections<br>9. Patient survival<br>10. Graft survival<br>11. Incidence of post transplant diabetes mellitus<br>;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<br>2. Proportion of patients who exhibit a specific urine proteomic pattern at month 12 comparing the two treatment groups