VIP: Vascular Imaging Project. Study on the Progression of Cardiovascular Disease in Renal Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
J.S.Mourer, Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT00169910
First received: September 9, 2005
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
Drug: AUC monitored withdrawal of MMF or CNI
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: VIP: Vascular Imaging Project. Prospective Randomized Study on the Effect of AUC-monitored Treatment With Steroids Combined With Either a Calcineurin Inhibitor or Mycophenolate Mofetil on the Progression of Subclinical Cardiovascular Disease in Renal Transplant Recipients.

Resource links provided by NLM:


Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • Primary endpoint: progression of subclinical cardiovascular disease as assessed by intima media thickness (IMT), pulse wave velocity (PWV) and left ventricular hypertrophy (LVH) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary endpoint: Cardiovascular risk factors: a) Hypertension, b) Hyperlipidemia, c) Diabetes mellitus/glucose intolerance [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Graft function [ Time Frame: 1 year, 3 years ] [ Designated as safety issue: Yes ]
  • Incidence of acute rejection [ Time Frame: 1 year, 3 years ] [ Designated as safety issue: Yes ]
  • Graft survival (creatinine clearance < 15 ml/min or dialysis) [ Time Frame: 1 year, 3 years ] [ Designated as safety issue: Yes ]
  • Patient survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 119
Study Start Date: December 2005
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
AUC monitored withdrawal of MMF
Drug: AUC monitored withdrawal of MMF or CNI
AUC monitored withdrawal of MMF or CNI from a immunosuppressive drug regimen with steroids, CNI and MMF in stable renal transplant recipients
Active Comparator: 2
AUC monitored withdrawal of CNI
Drug: AUC monitored withdrawal of MMF or CNI
AUC monitored withdrawal of MMF or CNI from a immunosuppressive drug regimen with steroids, CNI and MMF in stable renal transplant recipients

Detailed Description:

Stable renal transplant patients on maintenance immunosuppressive therapy with steroids, a calcineurin inhibitor (CNI) and mycophenolate mofetil (MMF) will be randomized for AUC-monitored withdrawal of either CNI or MMF.

The progression of cardiovascular markers will be assessed by yearly measurements of Intima Media Thickness, Pulse Wave Velocity and Left Ventricular Hypertrophy in both groups.

The duration of the study will be 3 years and the target sample size is 100 patients per arm

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169910

Locations
Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2300 RC
Sponsors and Collaborators
Leiden University Medical Center
Investigators
Study Chair: Johan W. de Fijter, MD,PhD Leiden University Medical Center
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: J.S.Mourer, MD, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT00169910     History of Changes
Other Study ID Numbers: P05.105
Study First Received: September 9, 2005
Last Updated: December 13, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Leiden University Medical Center:
Renal Transplantation
Calcineurin Inhibitor
Mycophenolate Mofetil
Cardiovascular Disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Mycophenolate mofetil
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014