Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation (CISTCERT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00903188|
Recruitment Status : Unknown
Verified May 2009 by University Hospital, Antwerp.
Recruitment status was: Recruiting
First Posted : May 18, 2009
Last Update Posted : May 18, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Renal Transplantation||Drug: cyclosporine Drug: Everolimus||Phase 4|
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)
De novo kidney transplant recipients.
1.5 years inclusion+ follow-up during the first 5 years
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||152 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2008|
|Estimated Primary Completion Date :||April 2010|
|Estimated Study Completion Date :||April 2015|
Active Comparator: Cyclosporine
Simulect + cyclosporine + Myfortic + steroid stop at 3 months
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
Active Comparator: Everolimus
Simulect + cyclosporine (decrease dose in one week at month 3 and replace by Everolimus (Certican)) + Myfortic + steroid maintenance
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.
- 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. [ Time Frame: 1 year ]
- To compare the evolution of graft function (estimated GFR by means of modified MDRD formula)during the first 5 years post transplantation. [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903188
|Contact: Jean-Louis Bosmans, MD/PhD||+32/3/821 37 email@example.com|
|Erasme University Hospital||Recruiting|
|Brussels, Belgium, 1070|
|Contact: Daniel Abramowicz, MD/PhD +32/2/555 35 32 firstname.lastname@example.org|
|Principal Investigator: Daniel Abramowicz, MD/PhD|
|University Hospital Brussels||Recruiting|
|Brussels, Belgium, 1090|
|Contact: Jacques Sennesael, MD/PhD +32/2/477 60 55 Jacques.Sennesael@uzbrussel.be|
|Principal Investigator: Jacques Sennesael, MD|
|University Hospital Antwerp||Recruiting|
|Edegem, Belgium, 2650|
|Contact: Jean-Louis Bosmans, MD/PhD +32/3/821 37 92 email@example.com|
|Contact: Angelika Jurgens, Study Coord. +32/3/821 34 21 Angelika.Jurgens@uza.be|
|Principal Investigator: Jean-Louis Bosmans, MD/PhD|
|University Hospital, Ghent||Recruiting|
|Gent, Belgium, 9000|
|Contact: Patrick Peeters, MD/PhD +32/9/332 45 13 firstname.lastname@example.org|
|Principal Investigator: Patrick Peeters, MD|
|University Hospital of Liege||Recruiting|
|Liège, Belgium, 4000|
|Contact: Catherine Bonvoisin, MD/PhD +32/4/366 82 58 email@example.com|
|Principal Investigator: Catherine Bonvoisin, MD|
|Principal Investigator:||Jean-Louis Bosmans, MD/PhD||University Hospital Antwerp - Department Nephrology-Hypertension|