A multi-center, randomized, controlled trial with programmed introduction of Sirolimus-based, Calcineurin inhibitor free immunosuppression in recipients of non-heart-beating donor kidney grafts.
- Conditions
- kidney transplant function10038430
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Age: at least 18 years
Acceptable renal function (eGFR Nankivell > 30 ml/min, proteinuria < 1.0 g/day)
3 - 4 months post renal transplantation with non-heart-beating donor graft
Banff grade > 2 acute or vascular rejection at any time during this transplant pre-randomization
Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant)..
Evidence of active systemic or localized major infection.
Planned use of agents with a known interaction with any of the following: sirolimus or its derivatives, macrolide antibiotics, corticosteroids, tacrolimus, or IMPDH inhibitor.
Immunosuppressive therapies other than those described above
Subjects with a screening/baseline total white blood cell count < 2,000/mm3 or ANC < 1000, platelet count < 100,000/mm3.
Fasting triglycerides > 400 mg/dL (> 4.5 mmol/L) or fasting total cholesterol > 300 mg/dL (> 7.8 mmol/L) despite optimal lipid-lowering therapy.
Subjects who are known to be HIV positive and/or subjects with active Hepatitis B or active Hepatitis C.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>eGFR as determined by Nankivell at month 12 post randomization.</p><br>
- Secondary Outcome Measures
Name Time Method