To determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.

Official Title

A randomized, open-label, comparative evaluation of conversion from calcineurin inhibitors to sirolimus versus continued use of calcineurin inhibitors in renal allograft recipients.

Conditions

– Renal Allograft Recipients

Study Type

Interventional

Study Design

Treatment

Further Details

Study Start

Eligibility & Criteria

Ages Eligible for Study: 13 Years and above, Genders Eligible for Study: Both Criteria Inclusion Criteria:Age greater than or equal to 13 years. Receiving CsA or tacrolimus from the time of transplantation or within 2 weeks thereafter. Patients with a functioning allograft and a Nankivell GFR greater than or equal to 20 mL/min, within 2 weeks before randomization. Six (6) to 60 months after renal transplantation. All female patients at risk for pregnancy must have a negative serum pregnancy test before randomization. Female patients 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. Signed and dated informed consent before screening and before any tests are performed that are specific to the protocol. A parent or legal guardian must provide written consent for patients younger than the age of majority defined by state and local laws. Patients younger than the age of majority will also sign an assent form. Exclusion Criteria:Biopsy-confirmed acute rejection within 12 weeks before randomization, that was determined to require antirejection treatment. Patients in whom kidney-pancreas or other multiple organ transplants have been performed

Total Enrolment

Contact Details

[1] Wyeth-Ayerst Research[2] Westmead Hospital, Westmead, 2145, Australia; Recruiting Phillip O’Connell, MD