Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation
NCT ID: NCT00903188
Last Updated: 2009-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
152 participants
INTERVENTIONAL
2008-10-31
2015-04-30
Brief Summary
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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.
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cyclosporine
Simulect + cyclosporine + Myfortic + steroid stop at 3 months
cyclosporine
Cyclosporine (Group 1):
basiliximab dose: 1x20 mg IV on Day 0 and 1x20 mg IV on Day 4
Cyclosporine: 8 mg/kg PO given before surgery, followed by 2x4 mg/kg/d. C-0h levels: month 1: 150-250 ng/ml; month 2: 100-200 ng/ml; month 3: withdrawal steroids: 100-150 ng/ml.
C-2h levels: month 1: 900-1100 ng/ml; month 2: 800-1000 ng/ml; month 3: withdrawal steroids: maintain level of 750 ng/ml
Enteric-coated mycophenolate(MPA):720mg PO pre-operatively followed by 1.44 g/day.
Steroids: pre-operatively: 250mg methylprednisolone IV; day 1:125mg IV.
Methylprednisolone:day 2-30:PO 12mg/d; day 31-60:tapered to 8mg/d ,day 61-90 :4mg/d; Month 3:stop
Everolimus
Simulect + cyclosporine (decrease dose in one week at month 3 and replace by Everolimus (Certican)) + Myfortic + steroid maintenance
Everolimus
Everolimus (Group 2):
Basiliximab dose: idem as in group 1
Cyclosporine: first three months idem group 1; month 3: decreased dose by 50%, simultaneously initiate everolimus at a starting dose of 0.75 mg bid.
Once the everolimus blood levels range 6 - 12 ng/ml, cyclosporine will be stopped.
Enteric-coated mycophenolate (MPA) dosing idem as group 1.
Everolimus starting dose: 0.75 mg bid, trough levels: 6-12 ng/ml.
Steroid dosing: idem group 1, but maintained at 4 mg methylprednisolone after day 60.
Interventions
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cyclosporine
Cyclosporine (Group 1):
basiliximab dose: 1x20 mg IV on Day 0 and 1x20 mg IV on Day 4
Cyclosporine: 8 mg/kg PO given before surgery, followed by 2x4 mg/kg/d. C-0h levels: month 1: 150-250 ng/ml; month 2: 100-200 ng/ml; month 3: withdrawal steroids: 100-150 ng/ml.
C-2h levels: month 1: 900-1100 ng/ml; month 2: 800-1000 ng/ml; month 3: withdrawal steroids: maintain level of 750 ng/ml
Enteric-coated mycophenolate(MPA):720mg PO pre-operatively followed by 1.44 g/day.
Steroids: pre-operatively: 250mg methylprednisolone IV; day 1:125mg IV.
Methylprednisolone:day 2-30:PO 12mg/d; day 31-60:tapered to 8mg/d ,day 61-90 :4mg/d; Month 3:stop
Everolimus
Everolimus (Group 2):
Basiliximab dose: idem as in group 1
Cyclosporine: first three months idem group 1; month 3: decreased dose by 50%, simultaneously initiate everolimus at a starting dose of 0.75 mg bid.
Once the everolimus blood levels range 6 - 12 ng/ml, cyclosporine will be stopped.
Enteric-coated mycophenolate (MPA) dosing idem as group 1.
Everolimus starting dose: 0.75 mg bid, trough levels: 6-12 ng/ml.
Steroid dosing: idem group 1, but maintained at 4 mg methylprednisolone after day 60.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Erasme University Hospital
OTHER
University Hospital, Ghent
OTHER
University of Liege
OTHER
Universitair Ziekenhuis Brussel
OTHER
University Hospital, Antwerp
OTHER
Responsible Party
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University Hospital Antwerp
Principal Investigators
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Jean-Louis Bosmans, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Antwerp - Department Nephrology-Hypertension
Locations
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Erasme University Hospital
Brussels, , Belgium
University Hospital Brussels
Brussels, , Belgium
University Hospital Antwerp
Edegem, , Belgium
University Hospital, Ghent
Ghent, , Belgium
University Hospital of Liege
Liège, , Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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Pipeleers L, Abramowicz D, Broeders N, Lemoine A, Peeters P, Van Laecke S, Weekers LE, Sennesael J, Wissing KM, Geers C, Bosmans JL. 5-Year outcomes of the prospective and randomized CISTCERT study comparing steroid withdrawal to replacement of cyclosporine with everolimus in de novo kidney transplant patients. Transpl Int. 2021 Feb;34(2):313-326. doi: 10.1111/tri.13798. Epub 2020 Dec 31.
Other Identifiers
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2007-005844-26
Identifier Type: -
Identifier Source: org_study_id
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