Status:
UNKNOWN
Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation
Lead Sponsor:
University Hospital, Antwerp
Collaborating Sponsors:
Novartis Pharmaceuticals
Erasme University Hospital
Conditions:
Renal Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 t...
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 + cyclosp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2015
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00903188
Start Date
October 1 2008
End Date
April 1 2015
Last Update
May 18 2009
Active Locations (5)
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1
Erasme University Hospital
Brussels, Belgium, 1070
2
University Hospital Brussels
Brussels, Belgium, 1090
3
University Hospital Antwerp
Edegem, Belgium, 2650
4
University Hospital, Ghent
Ghent, Belgium, 9000