Everolimus + Very Low Tacrolimus vs Enteric-coated Mycophenolate Sodium + Low Tacrolimus in de Novo Renal Transplant

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 12-month single center, randomized, open-label, single center study designed to compare the safety and efficacy of everolimus and very low dose tacrolimus versus enteric-coated sodium mycophenolate and low tacrolimus exposure in de novo kidney transplant recipients.

The purpose of this study is to compare safety and efficacy of two immunosuppressive regimens based on low tacrolimus exposure combined to everolimus or to enteric-coated mycophenolate sodium (EC-MPS) in de novo kidney transplant recipients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ronaldo de Matos Esmeraldo, MD
• Collaborator: Novartis Pharmaceuticals
• Treatments: Antilymphocyte Serum; Everolimus; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone; Sirolimus; Tacrolimus; Thymoglobulin

Criteria

Inclusion Criteria:

• Male or female renal recipients 18-75 years of age undergoing kidney transplantation, from a primary deceased donor (including expanded criteria donor organs), living unrelated or non-HLA identical living related donor kidney;

• Recipient of a kidney with a cold ischemia time < 30 hours;

• Graft must be functional (producing greater than or equal to 300 ml of urine within 24 hours after transplantation) at time of randomization.

Exclusion Criteria:

• Donor organ with a cold ischemic time > 30 hours;

• Patients who produce less than 300 ml of urine in the first 24 hours post-transplantation;

• Patients who are recipients of multiple organ transplants;

• Patients who are recipients of ABO incompatible transplants, or T or B cell cross match positive transplant;

• Patients with current Panel Reactive Antibodies (PRA) level ≥ 50%;

• Patients with severe hypercholesterolemia (350 mg/dl) or hypertriglyceridemia (500 mg/dl). Patients on lipid lowering treatment with controlled hyperlipidemia are acceptable;

• HIV positive patients;

• Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception;

• Decisional impaired subjects who are not medically or mentally capable of providing consent themselves.