Cardiovascular DiseasePhase 4NCT00169910
VIP: Vascular Imaging Project. Study on the Progression of Cardiovascular Disease in Renal Transplant Recipients
A Phase 4 study testing AUC monitored withdrawal of MMF or CNI in people with Cardiovascular Disease, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- AUC monitored withdrawal of MMF or CNI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2005to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients, 18 years or older, on triple maintenance therapy with cyclosporine or tacrolimus , MMF and steroids
- Informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Conditions
- Cardiovascular Disease
- Being tested
- AUC monitored withdrawal of MMF or CNI
- Keywords
- Renal Transplantation, Calcineurin Inhibitor, Mycophenolate Mofetil, Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | AUC monitored withdrawal of MMF Receives: Drug: AUC monitored withdrawal of MMF or CNI |
| 2 | Active comparator | AUC monitored withdrawal of CNI Receives: Drug: AUC monitored withdrawal of MMF or CNI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint: progression of subclinical cardiovascular disease as assessed by intima media thickness (IMT), pulse wave velocity (PWV) and left ventricular hypertrophy (LVH)
Measured: 3 years
Secondary outcomes (5)
Secondary endpoint: Cardiovascular risk factors: a) Hypertension, b) Hyperlipidemia, c) Diabetes mellitus/glucose intolerance
Measured: 3 years
Graft function
Measured: 1 year, 3 years
Incidence of acute rejection
Measured: 1 year, 3 years
Graft survival (creatinine clearance < 15 ml/min or dialysis)
Measured: 1 year, 3 years
Patient survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startDec 2005
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.S.Mourer, Leiden University Medical Center
- Investigators
- Johan W. de Fijter, MD,PhD, Study chair, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169910
- Sponsor's protocol ID
- P05.105
- Status last verified
- Dec 2012
- First submitted
- 9 Sep 2005
- Last updated
- 17 Dec 2012
- Results posted
- No
Publications
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.
PubMed 11805185O'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.
PubMed 9878640Blacher 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.
PubMed 10318666Mourer 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.
PubMed 23715049
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00169910
- Acronym / sponsor ID
- P05.105
- Conditions
- Cardiovascular Disease
- Keywords
- Renal Transplantation, Calcineurin Inhibitor, Mycophenolate Mofetil, Cardiovascular Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: AUC monitored withdrawal of MMF or CNIAUC monitored withdrawal of MMF |
| 2 | Active comparator | Drug: AUC monitored withdrawal of MMF or CNIAUC monitored withdrawal of CNI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients, 18 years or older, on triple maintenance therapy with cyclosporine or tacrolimus , MMF and steroids
- Informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AUC monitored withdrawal of MMF or CNIAUC monitored withdrawal of MMF or CNI from a immunosuppressive drug regimen with steroids, CNI and MMF in stable renal transplant recipients | Drug | 1, 2 |
Primary outcome
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
5 secondary outcomes
Secondary endpoint: Cardiovascular risk factors: a) Hypertension, b) Hyperlipidemia, c) Diabetes mellitus/glucose intolerance
Time frame: 3 years
Graft function
Time frame: 1 year, 3 years
Incidence of acute rejection
Time frame: 1 year, 3 years
Graft survival (creatinine clearance < 15 ml/min or dialysis)
Time frame: 1 year, 3 years
Patient survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
- Background: PubMed 11805185Schnuelle 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.
- Background: PubMed 9878640O'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.
- Background: PubMed 10318666Blacher 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.
- Derived from this study: PubMed 23715049Mourer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan W. de Fijter, MD,PhD study chair
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AUC monitored withdrawal of MMF or CNI in people with Cardiovascular Disease, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00169910, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2012.