Reduction or Discontinuation of CNI's With Conversion to Everolimus-Based Immunosuppresion

• Status: Unknown status
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study is design to compare two different strategies aiming to lessen the degree of the ongoing process of allograft injury either by removing tacrolimus from the maintenance immunosuppressive protocol or by reducing tacrolimus dose.

The primary goal is to assess the change in renal function at 6 and 12 months after conversion using creatinine levels and calculated creatinine clearance.

The study will include two groups: The study group of 30 patients and a matched control group with creatinine levels at similar range.

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

Details

• Lead Sponsor: Rabin Medical Center
• Collaborator: Novartis
• Treatments: Everolimus; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Patients on CNI FK < 5 ng/m"l with MPA / Imuran with or without steroids

• Renal impairment GFR between 30 - 70 m"l/minute/

• Patient who signed Informed consent

• Patient with no contraindication to renal biopsy

• Women who are not pregnant and will use contraception

Exclusion Criteria:

• Proteinuria > 100 m"g/mmol Creatinine

• Acute rejection during 3 months before screening

• WBC < 2500, plt < 50,000,

• Nephropathy due to polyoma virus

• Patients on other investigational drugs

• Patients on rapamycin

• Patients with HIV or other systemic infection

• Inability to comply with protocol requirements

• Active or history of malignancy