Condition category
Urological and Genital Diseases
Date applied
16/05/2005
Date assigned
16/05/2005
Last edited
09/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.umcutrecht.nl/zorg/

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

foundation

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

corporate

Location

United States of America

Funder name

Pfizer (Netherlands)

Alternative name(s)

Pfizer Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Funder name

Genzyme (Netherlands)

Alternative name(s)

Genzyme Corporation

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Additional files

Editorial Notes

09/05/2016: Publication reference added.