Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation (CISTCERT)

Antwerp University Hospital (UZA)

Status and phase: Unknown; Phase 4

Conditions: Renal Transplantation

Treatments: Drug: Everolimus; Drug: cyclosporine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00903188

2007-005844-26

Details and patient eligibility

About

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.

Full description

Methodology:

• A 5-year, multicentre, prospective, randomized, open-label, controlled study

  • Group 1: Simulect + cyclosporine + Myfortic + steroid stop at 3 months
  • Group 2: Simulect + cyclosporine (decrease dose in one week at month 3 and replace by everolimus) + Myfortic + steroid maintenance.

• In both groups MPA AUC monitoring will be done at 5-7 days and at 3 months, to ensure sufficient MPA protection.

Sample size calculations:

A total of 152 patients will be randomized (76 patients per group)

Population:

De novo kidney transplant recipients.

Study duration:

1.5 years inclusion+ follow-up during the first 5 years

Enrollment: 152 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 2 patient groups

Cyclosporine

Active Comparator group

Description:

Simulect + cyclosporine + Myfortic + steroid stop at 3 months

Treatment:

Drug: cyclosporine

Everolimus

Active Comparator group

Description:

Simulect + cyclosporine (decrease dose in one week at month 3 and replace by Everolimus (Certican)) + Myfortic + steroid maintenance

Treatment:

Drug: Everolimus