Open Label Comparative Study Of De Novo Renal Allograft Recipients Receiving CSA + MMF + Corticosteroids Versus CSA + Rapamune + Corticosteroids

• Conditions: Renal Transplantation; MedDRA version: 17.1Level: PTClassification code 10038533Term: Renal transplantSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2014-004102-15-Outside-EU/EEA
• Lead Sponsor: Wyeth

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-06
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

1.Age greater than or equal to (>=) 13 years and weight >=40 kg.
2.End-stage renal disease, with subjects receiving a primary or secondary renal allograft from a living-unrelated donor, or from a living-related donor.
3.Women who are of childbearing potential must have a negative pregnancy test before enrollment in the study and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation from the study.
4.Total white blood cell count >= 4.0 x 109/ Liter (L) (4,000/millimeter (mm) P^3) platelet count = 100 x 10^9/L (100,000/mm ^3), fasting triglycerides greater than or equal to <=4.6 miliimole per liter (mmol/L) (400 milligram per deciliter [mg/dL]), fasting cholesterol <= 7.8 mmol/L (300 mg/dL). If it is not possible to obtain fasting triglycerides and cholesterol before surgery, historical values (within 1 year) may be used.
5.Signed and dated informed consent (parent or legal guardian must provide consent for subjects less than (<) 18 years of age). An assent form will be signed by subjects < 18 years of age enrolled in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 245
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 228
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Evidence of active systemic or localized major infection at the time of initial Sirolimus administration.
2.Cadaveric donors
3.History of malignancy within 5 years before enrollment into the study (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin)
4.Use of any investigational drug other than specified in the protocol during the 4 weeks before enrolling in the study.
5.Use of planned antibody induction therapy at the time of transplantation.
6.Active gastrointestinal disorder that may interfere with drug absorption.
7.Known hypersensitivity to Sirolimus, Mycophenolat Mofetil (MMF) or Cyclosporine or its derivatives.
8.Multiple organ transplants (2 or more organ transplant e.g. Kidney and Pancreas).
9.Subject with high risk of rejection (eg. subjects with a PRA greater than (>) 50 percent (%), black subjects and subjects with 2nd transplant who lost their first graft within the first 6 months).
10.Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening

Study & Design

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