Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant

Conditions: Renal Transplantation
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Registration Number: EUCTR2006-005687-44-Outside-EU/EEA

Lead Sponsor: Wyeth Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 824

Inclusion Criteria

1. Age greater than equal to (=) 13 years.
2. Treatment with corticosteroids (dosage range 2.5 to 15 milligrams / day (mg/day) for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent) and either mycophenolate mofetil (MMF) (=500 mg/day) or azathioprine (AZA) (=50 mg/day) for a minimum of 12 weeks before randomization.
3. Receiving either cyclosporin A (CsA) or tacrolimus from the time of transplantation or within 2 weeks thereafter.
4. Subjects with a functioning allograft and a Nankivell glomerular filtration rate (GFR) = 40 milliliter/ minute (mL/min), within 2 weeks before randomization.
5. Six to 120 months after renal transplantation.
6. Greater than 12 weeks after treatment for any acute rejection.
7. Renal biopsy within 16 weeks before randomization.
8. All female Subjects at risk for pregnancy must have a negative serum pregnancy test before randomization. Female Subjects at risk for pregnancy must agree to use a medically acceptable method of contraception throughout the treatment period and for 12 weeks after discontinuation of study medication.
9. Total white blood cell count greater than (>) 3000/mm 3 [>3.0 * 109/Liter (L)], platelet count >100,000/mm 3(>100 * 109/L), fasting triglycerides <350 mg/dL [<3.95 millimoles/liter (mmol/L)], fasting cholesterol less than (<) 300 milligrams/ deciliter (mg/dL) (<7.8 mmol/L).
10. Signed and dated independent ethics committee (IEC)- approved informed consent before screening and before any protocol specified tests. A parent or legal guardian must provide written consent for Subjects younger than the age of majority as defined by state and local laws. Subjects younger than the age of majority may also sign an assent form.

Are the trial subjects under 18? yes
Number of subjects for this age range: 38
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 745
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 41

Exclusion Criteria

1.Clinically diagnosed or biopsy-confirmed acute rejection, as diagnosed by the Banff 97 classification within 12 weeks before randomization, that was determined to require anti-rejection treatment.
2.Serum creatinine at the time of screening that has increased by >30 percent (%) above the last value obtained at least 12 weeks earlier.
3.Subjects in whom kidney-pancreas or other multiple organ transplants have been performed.
4.Evidence of systemic infection at the time of randomization.
5.Presence of unstable angina or use of ongoing maintenance therapy for a life-threatening arrhythmia.
6.Known or suspected malignancy (with the exception of adequately treated basal cell or squamous cell carcinomas of the skin) less than equal to (=5) years before randomization or any history of posttransplant lymphoproliferative disease (PTLD).
7.Prior or current use of SRL or any of its derivatives.
8.Use of investigational agents =4 weeks before randomization.
9.Use of immunosuppressive agents (at the time of randomization)
10.Current use of terfenadine, cisapride, astemizole, pimozide, or cimetidine; these drugs must be discontinued before randomization. Cimetidine must be discontinued before the screening examination.
11.Positive past medical history for documented human immunodeficiency virus (HIV)infection.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method