NCT00169910

Brief Summary

This is a prospective randomized study to compare the influence of area under the curve (AUC)-monitored dual treatment with steroids in combination with either a calcineurin inhibitor (CNI) or mycophenolate mofetil (MMF) on the progression of subclinical cardiovascular disease in renal transplant recipients. Since CNI have a detrimental effect on cardiovascular risk factors, it is the researchers' hypothesis that renal recipients after CNI withdrawal will have more reduction of markers of cardiovascular disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
119

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 17, 2012

Status Verified

December 1, 2012

Enrollment Period

5 years

First QC Date

September 9, 2005

Last Update Submit

December 13, 2012

Conditions

Cardiovascular Disease

Keywords

Renal TransplantationCalcineurin InhibitorMycophenolate MofetilCardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Primary endpoint: progression of subclinical cardiovascular disease as assessed by intima media thickness (IMT), pulse wave velocity (PWV) and left ventricular hypertrophy (LVH)

    3 years

Secondary Outcomes (5)

  • Secondary endpoint: Cardiovascular risk factors: a) Hypertension, b) Hyperlipidemia, c) Diabetes mellitus/glucose intolerance

    3 years

  • Graft function

    1 year, 3 years

  • Incidence of acute rejection

    1 year, 3 years

  • Graft survival (creatinine clearance < 15 ml/min or dialysis)

    1 year, 3 years

  • Patient survival

    3 years

Study Arms (2)

1

ACTIVE COMPARATOR

AUC monitored withdrawal of MMF

Drug: AUC monitored withdrawal of MMF or CNI

2

ACTIVE COMPARATOR

AUC monitored withdrawal of CNI

Drug: AUC monitored withdrawal of MMF or CNI

Interventions

AUC monitored withdrawal of MMF or CNIDRUG

AUC monitored withdrawal of MMF or CNI from a immunosuppressive drug regimen with steroids, CNI and MMF in stable renal transplant recipients

12

Eligibility Criteria

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

You may qualify if:

  • Patients, 18 years or older, on triple maintenance therapy with cyclosporine or tacrolimus , MMF and steroids
  • Informed consent

You may not qualify if:

  • Calculated creatinine clearance \< 30 ml/min
  • Multi-organ recipients
  • Patients with a (historic) panel reactive antibody (PRA) \>60%
  • Third renal transplant or more.
  • Patients receiving investigational drugs other than MMF in combination with cyclosporine or tacrolimus
  • Solid malignancy, post-transplant lymphoproliferative disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

Related Publications (4)

  • Schnuelle P, van der Heide JH, Tegzess A, Verburgh CA, Paul LC, van der Woude FJ, de Fijter JW. Open randomized trial comparing early withdrawal of either cyclosporine or mycophenolate mofetil in stable renal transplant recipients initially treated with a triple drug regimen. J Am Soc Nephrol. 2002 Feb;13(2):536-543. doi: 10.1681/ASN.V132536.

    PMID: 11805185BACKGROUND

  • O'Leary DH, Polak JF, Kronmal RA, Manolio TA, Burke GL, Wolfson SK Jr. Carotid-artery intima and media thickness as a risk factor for myocardial infarction and stroke in older adults. Cardiovascular Health Study Collaborative Research Group. N Engl J Med. 1999 Jan 7;340(1):14-22. doi: 10.1056/NEJM199901073400103.

    PMID: 9878640BACKGROUND

  • Blacher J, Guerin AP, Pannier B, Marchais SJ, Safar ME, London GM. Impact of aortic stiffness on survival in end-stage renal disease. Circulation. 1999 May 11;99(18):2434-9. doi: 10.1161/01.cir.99.18.2434.

    PMID: 10318666BACKGROUND

  • Mourer JS, de Koning EJ, van Zwet EW, Mallat MJ, Rabelink TJ, de Fijter JW. Impact of late calcineurin inhibitor withdrawal on ambulatory blood pressure and carotid intima media thickness in renal transplant recipients. Transplantation. 2013 Jul 15;96(1):49-57. doi: 10.1097/TP.0b013e3182958552.

    PMID: 23715049DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

cni protein, Drosophila

Study Officials

  • Johan W. de Fijter, MD,PhD

    Leiden University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

December 1, 2005

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 17, 2012

Record last verified: 2012-12

Locations

NL(1)