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

May 15, 2009 updated by: University Hospital, Antwerp

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

152

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Recruiting
        • Erasme University Hospital
        • Contact:
          • Daniel Abramowicz, MD/PhD
          • Phone Number: +32/2/555 35 32
          • Email: dabram@ulb.ac.be
        • Principal Investigator:
          • Daniel Abramowicz, MD/PhD
      • Brussels, Belgium, 1090
        • Recruiting
        • University Hospital Brussels
        • Contact:
        • Principal Investigator:
          • Jacques Sennesael, MD
      • Edegem, Belgium, 2650
        • Recruiting
        • University Hospital Antwerp
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean-Louis Bosmans, MD/PhD
      • Gent, Belgium, 9000
        • Recruiting
        • University Hospital, Ghent
        • Contact:
      • Liège, Belgium, 4000
        • Recruiting
        • University Hospital of Liege
        • Contact:
        • Principal Investigator:
          • Catherine Bonvoisin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Cyclosporine
Simulect + cyclosporine + Myfortic + steroid stop at 3 months
Drug: 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

Other Names:
  • Simulect
  • Solumedrol
  • Medrol
  • Myfortic
  • Neoral
ACTIVE_COMPARATOR: Everolimus
Simulect + cyclosporine (decrease dose in one week at month 3 and replace by Everolimus (Certican)) + Myfortic + steroid maintenance
Drug: 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 Names:
  • Simulect
  • Solumedrol
  • Medrol
  • Certican
  • Myfortic
  • Neoral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Collaborators

Novartis Pharmaceuticals
University of Liege
University Hospital, Ghent
Universitair Ziekenhuis Brussel
Erasme University Hospital

Investigators

  • Principal Investigator: Jean-Louis Bosmans, MD/PhD, University Hospital Antwerp - Department Nephrology-Hypertension

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ANTICIPATED)

April 1, 2010

Study Completion (ANTICIPATED)

April 1, 2015

Study Registration Dates

First Submitted

May 15, 2009

First Submitted That Met QC Criteria

May 15, 2009

First Posted (ESTIMATE)

May 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 18, 2009

Last Update Submitted That Met QC Criteria

May 15, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-005844-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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