Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation

• Status: Unknown status
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study intends to determine whether steroid withdrawal or calcineurin inhibitor withdrawal is superior for graft function and graft survival. Secondary endpoints for this study are: incidence of tumors and cardiovascular events.

The primary objective: To assess if superior graft function (glomerular filtration rate (GFR) difference of 10 ml/min) will be achieved at 1 year after transplantation in cohorts of de novo kidney transplant patients treated with Myfortic-everolimus plus steroids compared to Myfortic-cyclosporine.

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

Details

• Lead Sponsor: University Hospital, Antwerp
• Collaborators: Erasme University Hospital; Novartis Pharmaceuticals; Universitair Ziekenhuis Brussel; University Hospital of Liege; University Hospital, Ghent; University of Liege
• Treatments: Antibodies, Monoclonal; Basiliximab; Calcineurin Inhibitors; Cyclosporine; Cyclosporins; Everolimus; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Sirolimus

Criteria

Inclusion Criteria:

• Male or female recipients of a de novo kidney transplant, aged above 18 years

• Women of childbearing potential must have a negative serum or urine pregnancy test with sensitivity equal to at least 50 mIU/ml

• Patients must be capable of understanding the purpose and risks of the study, and must sign an informed consent form

Exclusion Criteria:

• Multiple organ transplantation (e.g., Kidney-pancreas, kidney-heart, kidney- liver,...)

• Transplantation of a patient who got another organ transplant previously

• Recipients of a HLA-identical living-related renal transplant

• Patients with PRA > 30%, patients who have lost a first graft from rejection within two years after transplantation, and African European patients.

• Patients with primary renal disease at risk for recurrence: FSGS, MPGN, HUS

• Pregnant or lactating women

• WBC < 2.5 x 109/l (IU), platelet count < 100 x 109/l (IU), or Hb < 6 g/dl at the time of entry into the study

• Active peptic ulcer

• Severe diarrhea or other gastrointestinal disorder, which might interfere with their ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy

• Known HIV-1 or HTLV-1 positive tests

• The use of investigational drugs or other immunosuppressive drugs, as those specified in this protocol

• Patients receiving bile acid sequestrants

• Psychological illness or condition, interfering with the patient's compliance or ability to understand the requirements of the study