Contact information
Type
Scientific
Primary contact
Dr Arjan van Zuilen
ORCID ID
Contact details
Department of Nephrology
University Medical Center Utrecht
F03-226
PO Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 250 97 68
a.vanzuilen@azu.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2003B261; NTR22
Study information
Scientific title
Prevention of cardiovascular disease and progression of renal failure in patients with chronic renal insufficiency: implementation of maximal endothelial protection with the aid of nurse practitioners - a randomised multi-centre study
Acronym
MASTERPLAN
Study hypothesis
Does intensive multifactorial coaching of patients with chronic renal insufficiency by nurse practitioners result in a reduction in cardiovascular events, cardiovascular mortality, all cause mortality and change in decline of renal function?
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Multicentre randomised active-controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic renal insufficiency, renal transplant, cardiovascular disease
Intervention
After the baseline evaluation, the patient will be randomised to either nurse practitioner care or physician care. To all patients the same set of guidelines and treatment goals, shown below, apply. Both patients and physicians are provided with information about the beneficial effects of multifactorial risk factor management regardless of treatment allocation. In the intervention group nurse practitioners, supervised by a qualified nephrologist, will actively pursue lifestyle intervention (physical exercise, nutritional counseling, weight reduction and smoking cessation), the use of specified cardioprotective medication and the implementation of current guidelines. Physician care comprises 'usual care' and conforms to the guidelines below.
Targets and guidelines:
1. Blood pressure:
Standard: ACE-inhibitor or AII-antagonist (irbesartan)
Target: less than 130/85 mmHg (less than 125/75 mmHg with proteinuria greater than 1 g/day)
2. Proteinuria intensify anti-hypertensive therapy
Target: less than 0.5 g/dag
3. Dyslipidaemia:
Standard: atorvastatine 10 mg
Target: Low Density Lipoprotein (LDL) cholesterol less than 2.59 mmol/l
4. Anaema Hb less than 6.8 mmol/l: Start darbepoietin alfa, treat iron deficiency
5. Hyperhomocysteinemia: Standard folic acid 5 mg/dag
6. Thrombocyte aggregation: Acetylsalicylic acid 80 mg/dag unless contra-indicated
7. Diabetes mellitus:
Target: HbA1c less than 7% (preprandial glucose less than 7.0 mmol/l, postprandial glucose less than 10.0 mmol/l)
8. Calcium-Phosphate:
Standard: alfacalcidol 0.25 µg/dag with clearance less than 50 ml/min
Target: Phosphate less than 1.8 mmol/l and calcium 2.40 - 2.60 mmol/l (parathyroid hormone (PTH) 1 - 3 x normal)
9. Lifestyle:
Standard: education about healthy nutrition by a qualified dietician
Target: optimal bodyweight
Standard: optimising physical activity to the level required by dutch guidelines
Standard in case of smoking: stop smoking intervention
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Assessment of cardiovascular morbidity (comprised of myocardial infarction, stroke and all vascular interventions, including amputation of an extremity due to vascular insufficiency)
2. Cardiovascular mortality
3. All cause mortality
Secondary outcome measures
1. Decline in renal function, this will be established by annual measurement of creatinine clearance by 24-hour urine measurements
2. Quality of life, will be assessed using a validated questionnaire
3. Markers of vascular damage: aortic pulse wave velocity, carotid intimal media thickness and the ankle-brachial index
Overall trial start date
21/04/2004
Overall trial end date
21/04/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. The subject is at least 18 years old
2. The subject is diagnosed with chronic kidney disease (CKD) with a creatinine clearance estimated by the Cockcroft-Gault equation between 20 and 70 ml/min
3. The subject is able and willing to provide written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
800
Participant exclusion criteria
None of the exclusion criteria can be present. The following conditions are considered exclusion criteria:
1. A renal transplant less than a year before inclusion
2. Acute renal failure or rapidly progressive glomerulonephritis established by the treating physician
3. Any malignancy less than five years before inclusion other than basocellular or squamous cell carcinoma of the skin
4. Participation in other clinical trials requiring the use of study medication
Recruitment start date
21/04/2004
Recruitment end date
21/04/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Utrecht
Utrecht
3508 GA
Netherlands
Sponsor information
Organisation
University Medical Centre Utrecht (UMCU) (Netherlands)
Sponsor details
PO Box 85500
Utrecht
3508 GA
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Dutch Kidney Foundation (Nierstichting Nederland) (Netherlands) (ref: pv-01)
Alternative name(s)
Dutch Kidney Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
Netherlands
Funder name
Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands) (ref: 2003B261)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Amgen (Netherlands)
Alternative name(s)
Amgen Inc., Applied Molecular Genetics Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Funder name
Pfizer (Netherlands)
Alternative name(s)
Pfizer Inc., Pfizer Consumer Healthcare
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Funder name
Genzyme (Netherlands)
Alternative name(s)
Genzyme Corporation
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2005 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/15772920
2. 2006 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/16573836
3. 2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18587712
4. 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20382963
5. 2012 substudy results in: http://www.ncbi.nlm.nih.gov/pubmed/22530966
6. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22739979
7. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24158983
8. 2013 post-hoc analysis results in: http://www.ncbi.nlm.nih.gov/pubmed/24215017
9. 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/25700931
Publication citations
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Protocol
Van Zuilen AD, Wetzels JF, Blankestijn PJ, Bots ML, Van Buren M, Ten Dam MA, Kaasjager KA, Van De Ven PJ, Vleming LJ, Ligtenberg G, Ligtenberg G, , Rationale and design of the MASTERPLAN study: Multifactorial approach and superior treatment efficacy in renal patients with the aid of nurse practitioners., J. Nephrol., 18, 1, 30-34.
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Protocol
van Zuilen AD, van der Tweel I, Blankestijn PJ, Bots ML, van Buren M, ten Dam MA, Kaasjager KA, van de Ven PJ, Vervoort G, Vleming LJ, Ligtenberg G, Wetzels JF, , Multifactorial approach and superior treatment efficacy in renal patients with the aid of nurse practitioners. Design of The MASTERPLAN Study [ISRCTN73187232]., Trials, 2006, 7, 8, doi: 10.1186/1745-6215-7-8.
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Results
Van Zuilen AD, Wetzels JF, Bots ML, Van Blankestijn PJ, , MASTERPLAN: study of the role of nurse practitioners in a multifactorial intervention to reduce cardiovascular risk in chronic kidney disease patients., J. Nephrol., 21, 3, 261-267.
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Results
van Zuilen AD, Blankestijn PJ, van Buren M, ten Dam MA, Kaasjager KA, Ligtenberg G, Sijpkens YW, Sluiter HE, van de Ven PJ, Vervoort G, Vleming LJ, Bots ML, Wetzels JF, , Quality of care in patients with chronic kidney disease is determined by hospital specific factors., Nephrol. Dial. Transplant., 2010, 25, 11, 3647-3654, doi: 10.1093/ndt/gfq184.
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Substudy results
Vervloet MG, van Zuilen AD, Heijboer AC, ter Wee PM, Bots ML, Blankestijn PJ, Wetzels JF, , Fibroblast growth factor 23 is associated with proteinuria and smoking in chronic kidney disease: an analysis of the MASTERPLAN cohort., BMC Nephrol, 2012, 13, 20, doi: 10.1186/1471-2369-13-20.
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Results
van Zuilen AD, Bots ML, Dulger A, van der Tweel I, van Buren M, Ten Dam MA, Kaasjager KA, Ligtenberg G, Sijpkens YW, Sluiter HE, van de Ven PJ, Vervoort G, Vleming LJ, Blankestijn PJ, Wetzels JF, Multifactorial intervention with nurse practitioners does not change cardiovascular outcomes in patients with chronic kidney disease., Kidney Int., 2012, 82, 6, 710-717, doi: 10.1038/ki.2012.137.
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Results
Peeters MJ, van Zuilen AD, van den Brand JA, Bots ML, van Buren M, Ten Dam MA, Kaasjager KA, Ligtenberg G, Sijpkens YW, Sluiter HE, van de Ven PJ, Vervoort G, Vleming LJ, Blankestijn PJ, Wetzels JF, Nurse practitioner care improves renal outcome in patients with CKD., J. Am. Soc. Nephrol., 2014, 25, 2, 390-398, doi: 10.1681/ASN.2012121222.
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Results
Bouma-de Krijger A, Bots ML, Vervloet MG, Blankestijn PJ, Ter Wee PW, van Zuilen AD, Wetzels JF, Time-averaged level of fibroblast growth factor-23 and clinical events in chronic kidney disease., Nephrol. Dial. Transplant., 2014, 29, 1, 88-97, doi: 10.1093/ndt/gft456.
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Results
Bech AP, Bouma-de Krijger A, van Zuilen AD, Bots ML, van den Brand JA, Blankestijn PJ, Wetzels JF, Vervloet MG, Impact of fractional phosphate excretion on the relation of FGF23 with outcome in CKD patients, J Nephrol, 2015, 28, 4, 477-484, doi: 10.1007/s40620-015-0178-0.