Study Evaluating Rapamune® Maintenance Regime

• 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: EUCTR2014-004101-33-Outside-EU/EEA
• Lead Sponsor: Wyeth Korea, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-07
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

1. Age great than (>) 13 years
2. End-stage renal disease, with subjects receiving a primary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor. A mismatch is defined as a donor human leukocyte antigen (HLA) antigen not shared by the patient.
3. All female subjects at risk for pregnancy must have a negative pregnancy test result before sirolimus administration, and must agree and commit to the use of a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of study medication. A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. Any female subject who becomes pregnant during the treatment period must be discontinued from the on-therapy portion of the study.
4. Total white blood cell count greater than or equal to (>=) 4,000/ cubic millimeter (mm^3) (4.0 *10^9 /liter [L]), platelet count >= 100,000/mm^3 (100 x 10 9/L, fasting triglycerides >=400 milligram per deciliter (mg/dL), and fasting cholesterol >= 300 mg/dl. If it is not possible to obtain fasting triglycerides and cholesterol before surgery, historical values less than (<) 1 year may be used.
5. Signed and dated informed consent (parent or legal guardian must provide consent for patients <18 years of age). If possible, an assent form will be signed by patients <18 years of age enrolled in the study.
6. Patients with a panel of reactive antibody (%PRA) less than equal to (<=) 50 percent (%).

Are the trial subjects under 18? yes
Number of subjects for this age range: 22
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 57
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. Evidence of infiltration, cavitation, or consolidation on chest x-ray obtained during pre-study screening
3. Chronic antiarrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery
4. 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).
5. Use of any investigational drug during the 4 weeks before enrolling in the study.
6. Presence of 4 or more HLA mismatches.
7. Active gastrointestinal disorder that may interfere with drug absorption.
8. Known hypersensitivity to sirolimus or its derivatives.
9. Multiple organ transplants

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients.;Secondary Objective: To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal transplantation recipients.<br>To evaluate graft function, subject survival and graft survival at 6, 12 months after transplantation, and biopy confirmed acute rejection rate within 12 months after transplantation.<br>;Primary end point(s): Number of subjects experiencing biopsy confirmed acute rejection through month 6 after transplantation.;Timepoint(s) of evaluation of this end point: 6 months after transplantation

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 1) 6 and 12 months<br>2) Baseline, 6 and 12 months<br>3) 12 months<br>4) 12 months after transplantation;Secondary end point(s): 1) Glomerular Filtration Rate (GFR) (Nankivell Method)<br>2) Serum Creatinine<br>3) Subject and Graft Survival<br>4) Number of subjects Experiencing Biopsy Confirmed Acute Rejection Through Month 12 After Transplantation