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Multifactorial Approach and Superior Treatment Efficacy in Renal Patients with the Aid of Nurse practitioners
DOI 10.1186/ISRCTN73187232
ClinicalTrials.gov identifier
EudraCT number
Public title Multifactorial Approach and Superior Treatment Efficacy in Renal Patients with the Aid of Nurse practitioners
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
Serial number at source 2003B261; NTR22
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?
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the local medical ethics committee
Study design Multicentre randomised active controlled parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Chronic renal insufficiency, renal transplant, cardiovascular disease
Participants - 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
Participants - 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
Anticipated start date 21/04/2004
Anticipated end date 21/04/2009
Status of trial Completed
Patient information material
Target number of participants 800
Interventions 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
Primary outcome measure(s) 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 measure(s) 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
Sources of funding 1. Dutch Kidney Foundation (Nierstichting Nederland) (Netherlands) (ref: pv-01)
2. Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands) (ref: 2003B261)

Unrestricted grants from:
1. Amgen (Netherlands)
2. Pfizer (Netherlands)
3. Genzyme (Netherlands)
Trial website
Publications 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
Contact name Dr  Arjan  van Zuilen
  Address Department of Nephrology
University Medical Center Utrecht
P.O. Box 85500
  City/town Utrecht
  Zip/Postcode 3508 GA
  Country Netherlands
  Tel +31 (0)30 250 97 68
  Fax +31 (0)30 254 34 92
  Email a.vanzuilen@azu.nl
Sponsor University Medical Centre Utrecht (UMCU) (Netherlands)
  Address P.O. Box 85500
  City/town Utrecht
  Zip/Postcode 3508 GA
  Country Netherlands
  Sponsor website: http://www.umcutrecht.nl/zorg/
Date applied 16/05/2005
Last edited 13/01/2014
Date ISRCTN assigned 16/05/2005
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