Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation
Information source: University Hospital, Antwerp
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Transplantation
Intervention: cyclosporine (Drug); Everolimus (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Hospital, Antwerp Official(s) and/or principal investigator(s):
Jean-Louis Bosmans, MD/PhD, Principal Investigator, Affiliation: University Hospital Antwerp - Department Nephrology-Hypertension
Overall contact:
Jean-Louis Bosmans, MD/PhD, Phone: +32/3/821 37 92, Email: jeanlouis.bosmans@ua.ac.be
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.
Clinical Details
Official title: Impact of Cyclosporine or Steroid Withdrawal at 3 Months Post Transplantation on Graft Function, Patient Survival and Cardiovascular Surrogate Markers the First 5 Years After Renal Transplantation.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To assess if superior graft function (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.
Secondary outcome: To compare the evolution of graft function (estimated GFR by means of modified MDRD formula)during the first 5 years post transplantation.
Detailed 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Jean-Louis Bosmans, MD/PhD, Phone: +32/3/821 37 92, Email: jeanlouis.bosmans@ua.ac.be
Erasme University Hospital, Brussels 1070, Belgium; Recruiting
Daniel Abramowicz, MD/PhD, Phone: +32/2/555 35 32, Email: dabram@ulb.ac.be
Daniel Abramowicz, MD/PhD, Principal Investigator
University Hospital Brussels, Brussels 1090, Belgium; Recruiting
Jacques Sennesael, MD/PhD, Phone: +32/2/477 60 55, Email: Jacques.Sennesael@uzbrussel.be
Jacques Sennesael, MD, Principal Investigator
University Hospital Antwerp, Edegem 2650, Belgium; Recruiting
Jean-Louis Bosmans, MD/PhD, Phone: +32/3/821 37 92, Email: jeanlouis.bosmans@ua.ac.be
Angelika Jurgens, Study Coord., Phone: +32/3/821 34 21, Email: Angelika.Jurgens@uza.be
Jean-Louis Bosmans, MD/PhD, Principal Investigator
University Hospital, Ghent, Gent 9000, Belgium; Recruiting
Patrick Peeters, MD/PhD, Phone: +32/9/332 45 13, Email: patrick.peeters@ugent.be
Patrick Peeters, MD, Principal Investigator
University Hospital of Liege, Liège 4000, Belgium; Recruiting
Catherine Bonvoisin, MD/PhD, Phone: +32/4/366 82 58, Email: catherine.bonvoisin@chu.ulg.ac.be
Catherine Bonvoisin, MD, Principal Investigator
Additional Information
Starting date: October 2008
Last updated: May 15, 2009
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