Planned Transition to Sirolimus-based Therapy Versus Continued Tacrolimus-based Therapy in Renal Allograft Recipients - ND

• Conditions: Renal function in kidney transplant.; MedDRA version: 12.1Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejection

• Registration Number: EUCTR2008-006840-20-IT
• Lead Sponsor: Wyeth Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-28
• Last Update Posted: 21 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1.Male or female subjects aged 18 years or older.
2.Will receive or have received, no earlier than 14 days prior to transplantation and no later than 2 days after transplantation, a primary, living- or deceased-donor renal allograft.
3.All female and male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study and for 3 months after the last dose of test article. A subject is biologically capable of having children even if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.
RANDOMIZATION
1.Ninety (90) to 150 days post-transplantation.
2.Treatment with TAC and an IMPDH inhibitor initiated ≤ 30 days of transplantation and has remained on both for the 30 days prior to randomization.
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

SCREENING
1.Recipients of multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant).
2.Recipients of adult or pediatric en bloc kidney transplants.
3.Recipients who required or will require desensitization protocols.
4.Known history of focal segmental glomerulosclerosis (FSGS) or membranoproliferative glomerulonephritis (MPGN).
5.Evidence of active systemic or localized major infection, as determined by the investigator.
6.Received any investigational drugs or devices ≤ 30 days prior to transplantation.
7.Known or suspected allergy to SRL, TAC, IMPDH inhibitor, macrolide antibiotics, or other compounds related to these classes of medication.
8.Planned treatment with immunosuppressive therapies other than those described in the protocol.
9.History of malignancy ≤ 3 years of screening (except for adequately treated basal cell or squamous cell carcinoma of the skin).
10.Recipients who are known to be human immunodeficiency virus (HIV) positive.
11.Women who are biologically capable of having children with a positive urine or serum pregnancy test.
12.Breastfeeding women.
RANDOMIZATION
1.Any major illness/condition that, in the investigators judgment, will substantially increase the risk associated with the subjects participation in and completion of the study, or could preclude the evaluation of the subjects response.
2.Treatment with immunosuppressive therapies other than those described in the protocol.
3.Subjects who underwent CS withdrawal or avoidance and did not receive antibody induction at the time of transplantation with anti-thymocyte globulin (rabbit) (rATG) (Thymoglobulin) or alemtuzumab (Campath).
4.Subjects who have had CS discontinued ≤ 30 days before randomization.
5.Calculated GFR < 40 mL/min/1.73m2 using the simplified Modification of Diet in Renal Disease (MDRD) formula ≤ 2 weeks prior to randomization.
6.Spot urine protein to creatinine ratio (UPr/Cr) ≥ 0.5 ≤ 2 weeks prior to randomization.
7.Banff (2007) grade 2 or higher acute T-cell-mediated or any acute antibody-mediated rejection at any time post-transplantation.
8.Any acute rejection (biopsy-confirmed or presumed) ≤ 30 days before randomization.
9.More than 1 episode of acute rejection (biopsy-confirmed or presumed).
10.Known Banff (2007) interstitial fibrosis and tubular atrophy (IF/TA) ≥ grade 2 or recurrent/de novo glomerular disease.
11.Major surgery ≤ 2 weeks prior to randomization.
12.Active post-operative complication, e.g. infection, delayed wound healing.
13.Total white blood cell count < 2,000/mm3 or absolute neutrophil count (ANC) < 1000, platelet count < 100,000/mm3 ≤ 2 weeks prior to randomization.
14.Fasting triglycerides > 400 mg/dL (> 4.5 mmol/L) or fasting total cholesterol > 300 mg/dL
(> 7.8 mmol/L) ≤ 2 weeks prior to randomization despite lipid-lowering therapy.
15.Women who are biologically capable of having children with a positive urine or serum pregnancy test.
16.Breastfeeding women.

Study & Design

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