Multifactorial Approach and Superior Treatment Efficacy in Renal Patients with the Aid of Nurse practitioners

ISRCTN	ISRCTN73187232
DOI	https://doi.org/10.1186/ISRCTN73187232
Secondary identifying numbers	2003B261; NTR22

Submission date: 16/05/2005
Registration date: 16/05/2005
Last edited: 09/05/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Arjan van Zuilen
Scientific

Department of Nephrology
University Medical Center Utrecht
F03-226
PO Box 85500
Utrecht
3508 GA
Netherlands

Phone	+31 (0)30 250 97 68
Email	a.vanzuilen@azu.nl

Study information

Study design	Multicentre randomised active-controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	MASTERPLAN
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
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 study start date	21/04/2004
Completion date	21/04/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	800
Key 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
Key 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
Date of first enrolment	21/04/2004
Date of final enrolment	21/04/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Utrecht

Utrecht
3508 GA
Netherlands

Sponsor information

University Medical Centre Utrecht (UMCU) (Netherlands)
Hospital/treatment centre

PO Box 85500
Utrecht
3508 GA
Netherlands

Website	http://www.umcutrecht.nl/zorg/
"ROR"	https://ror.org/04pp8hn57

Funders

Funder type

Research organisation

Dutch Kidney Foundation (Nierstichting Nederland) (Netherlands) (ref: pv-01)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Dutch Kidney Foundation
Location: Netherlands

Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands) (ref: 2003B261)

No information available

Amgen (Netherlands)
Government organisation / For-profit companies (industry)

Alternative name(s): Amgen Inc., Applied Molecular Genetics Inc.
Location: United States of America

Pfizer (Netherlands)
Government organisation / For-profit companies (industry)

Alternative name(s): Pfizer Inc., Pfizer Consumer Healthcare, Davis, Charles Pfizer & Company, Warner-Lambert, King Pharmaceuticals, Wyeth Pharmaceuticals, Seagen
Location: United States of America

Genzyme (Netherlands)
Private sector organisation / For-profit companies (industry)

Alternative name(s): Genzyme Corporation
Location: United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/01/2005	Yes	No
Protocol article	protocol	30/03/2006	Yes	No
Results article	results	01/05/2008	Yes	No
Results article	results	01/11/2010	Yes	No
Results article	substudy results	24/04/2012	Yes	No
Results article	results	01/09/2012	Yes	No
Results article	post-hoc analysis results	01/01/2014	Yes	No
Results article	results	01/02/2014	Yes	No
Results article	results	01/08/2015	Yes	No

Editorial Notes

09/05/2016: Publication reference added.