Renal Transplantation MedDRA version: 7.1 Level: PT Classification code 10038533
Conditions
Interventions
Trade Name: Zenapax
Product Name: Zenapax
Product Code: Ro 24-7375
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: daclizumab
CAS Number: Ro-7375
Concentration unit: mg
Sponsors
Barts and the London NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The enrolled patients must fulfill the following inclusion criteria: 1.Male and female patients between 18 and 75 years of age 2.Patients scheduled for a single-organ, renal transplantation from living or cadaver donors. Patient receiving second renal transplants can be included, provided that the previous graft was not lost from acute rejection within the first year. 3.Patients capable of understanding the purposes and risks of the study, who give written informed consent and who are willing to participate to and comply with the study. 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: The following groups of patients will not be included in the study: 1.Women lactating, pregnant or of childbearing potential not using a reliable contraceptive method before beginning study drug therapy, during therapy and for 4 months following their last dose of the drugs administered within this clinical study. 2.Patients receiving the third or higher renal transplant. 3.Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy. 4.Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study. 5.Patients with evidence of an active systemic infection requiring the continued use of antibiotics or evidence of an HIV infection, or the presence of a chronic active hepatitis B (HBs-Ag positive) or C. 6.Patients with history of malignancy (except successfully treated localized non-melanocitic skin cancer). 7.Patients with active peptic ulcer disease. 8.Patients with evidence of an active liver disease 9.Patients with severe anemia (Hb 50% within 6 months prior to enrollment; 13.Cold ischemia time of the graft of more than 30 hours; 14.Patients who had received an investigational new drug within the last three months. 15.Patients previously treated with daclizumab or basiliximab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the present investigation is to compare the incidence or avoidance of corticosteroid use, as a measure of the decreased incidence of acute rejection episodes 6 and 12 months after primary renal transplantation in patients receiving three different immunosuppressive treatments. Current standard immunosuppression (group A: mycophenolate mofetil, tacrolimus and corticosteroids) will be compared to regimens with mycophenolate mofetil, daclizumab and a single week of corticosteroids as mainstay immunosuppression in combination with tacrolimus (group B) or (group C) where sirolimus, MMF and steroids will be continued.;Secondary Objective: Secondary objectives are: •to determine the patient and graft survival rates at 12 months and the proportion of patients experiencing treatment failure at 12 months, •to evaluate the renal function as expressed by the serum creatinine and the calculated GFR over the course of the study, and •to characterize the safety (including hypertension, hyperlipidemia, etc.) of these combinations at 6 and 12 months posttransplant. •To specifically evaluate the impact of steroid use on bone density with the use of DEXA scanning at 3 and 12 months. ;Primary end point(s): Primary Aim The primary aims of this study are to compare to incidence or avoidance of corticosteroid use in patients receiving three different immunosuppressive treatments. Primary Efficacy Parameter The primary efficacy parameter of the study is the incidence of reinitialisation of steroid or CNI ( calcineurin inhibitor) as a result of acute rejection episodes at 12 months. | — |
Countries
United Kingdom
Outcome results
None listed