NCT00903188

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_4

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 18, 2009

Status Verified

May 1, 2009

Enrollment Period

1.5 years

First QC Date

May 15, 2009

Last Update Submit

May 15, 2009

Conditions

Renal Transplantation

Keywords

Renal Transplantationgraft functioncardiovascular eventsmalignancycyclosporinsteroidsmycophenolateeverolimusrenal biopsiespharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (1)

  • To compare the evolution of graft function (estimated GFR by means of modified MDRD formula)during the first 5 years post transplantation.

    5 years

Study Arms (2)

Cyclosporine

ACTIVE COMPARATOR

Simulect + cyclosporine + Myfortic + steroid stop at 3 months

Drug: cyclosporine

Everolimus

ACTIVE COMPARATOR

Simulect + cyclosporine (decrease dose in one week at month 3 and replace by Everolimus (Certican)) + Myfortic + steroid maintenance

Drug: Everolimus

Interventions

cyclosporineDRUG

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

Also known as: Neoral, Myfortic, Solumedrol, Medrol, Simulect
Cyclosporine
EverolimusDRUG

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.

Also known as: Certican, Neoral, Myfortic, Solumedrol, Medrol, Simulect
Everolimus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Erasme University Hospital

Brussels, 1070, Belgium

RECRUITING

University Hospital Brussels

Brussels, 1090, Belgium

RECRUITING

University Hospital Antwerp

Edegem, 2650, Belgium

RECRUITING

University Hospital, Ghent

Ghent, 9000, Belgium

RECRUITING

University Hospital of Liege

Liège, 4000, Belgium

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33277746DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

CyclosporineMycophenolic AcidMethylprednisolone HemisuccinateMethylprednisoloneBasiliximabEverolimus

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsCaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsSirolimusMacrolidesLactones

Study Officials

  • Jean-Louis Bosmans, MD/PhD

    University Hospital Antwerp - Department Nephrology-Hypertension

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Louis Bosmans, MD/PhD

CONTACT

+32/3/821 37 92jeanlouis.bosmans@ua.ac.be

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 15, 2009

First Posted

May 18, 2009

Study Start

October 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2015

Last Updated

May 18, 2009

Record last verified: 2009-05

Locations

BE(5)