E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of cytomegalovirus (CMV) disease in kidney transplant recipients |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10023439 |
E.1.2 | Term | Kidney transplant rejection |
E.1.2 | System Organ Class | 10021428 - Immune system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the incidence of CMV disease and corresponding renal graft alteration |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Pre-emptive therapy with valganciclovir |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 21 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 23 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 9 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 9 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |