NCT00420537

Brief Summary

The purpose of this study is to verify if the combination of Everolimus with a very low dose of cyclosporine is more effective than the combination of mycophenolate mofetil with low-dose of cyclosporine in reducing the progression of kidney dysfunction in patients with heart transplantation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

January 12, 2010

Status Verified

May 1, 2009

Enrollment Period

2.3 years

First QC Date

January 9, 2007

Last Update Submit

January 11, 2010

Conditions

Kidney DysfunctionHeart Transplantation

Keywords

KidneyHeart TransplantationCreatinineGlomerular Filtration Rate

Outcome Measures

Primary Outcomes (1)

  • Calculated GFR

    One year after randomization

Study Arms (2)

mycophenolate

ACTIVE COMPARATOR

Mycophenolate mofetil with cyclosporine trough levels between 100 and 150

Drug: cyclosporineDrug: Mycophenolate mofetil

Everolimus

ACTIVE COMPARATOR

Everolimus with cyclosporine trough levels between 40 and 90 ng/ml

Drug: cyclosporineDrug: Everolimus

Interventions

cyclosporineDRUG

cyclosporine trough levels between 100 and 150

mycophenolate
Mycophenolate mofetilDRUG

mycophenolate with low doses

mycophenolate
EverolimusDRUG
Everolimus

Eligibility Criteria

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

You may qualify if:

  • Heart Transplant with 1 to 4 years of follow-up
  • GFR between 20 and 60 ml/min (calculated with Colkoroft-Gault formula)

You may not qualify if:

  • Acute rejection in the previous 6 months
  • Contraindications to statin therapy
  • Ongoing infection
  • Ongoing heart failure
  • Myocardial infarction or myocardial revascularization after transplant
  • Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico S.Orsola-Malpighi

Bologna, 40138, Italy

Location

Related Publications (2)

  • Lehmkuhl H, Ross H, Eisen H, Valantine H. Everolimus (certican) in heart transplantation: optimizing renal function through minimizing cyclosporine exposure. Transplant Proc. 2005 Dec;37(10):4145-9. doi: 10.1016/j.transproceed.2005.10.005.

    PMID: 16387066BACKGROUND

  • Eisen HJ, Tuzcu EM, Dorent R, Kobashigawa J, Mancini D, Valantine-von Kaeppler HA, Starling RC, Sorensen K, Hummel M, Lind JM, Abeywickrama KH, Bernhardt P; RAD B253 Study Group. Everolimus for the prevention of allograft rejection and vasculopathy in cardiac-transplant recipients. N Engl J Med. 2003 Aug 28;349(9):847-58. doi: 10.1056/NEJMoa022171.

    PMID: 12944570BACKGROUND

MeSH Terms

Interventions

CyclosporineMycophenolic AcidEverolimus

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsCaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsSirolimusMacrolidesLactones

Study Officials

  • Angelo Branzi, MD

    Alma Mater Studiorum University of Bologna

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

January 9, 2007

First Posted

January 11, 2007

Study Start

September 1, 2006

Primary Completion

January 1, 2009

Study Completion

March 1, 2009

Last Updated

January 12, 2010

Record last verified: 2009-05

Locations

IT(1)