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

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN73187232
• Date of registration: 16/05/2005
• Prospective Registration: No
• Primary sponsor: University Medical Centre Utrecht (UMCU) (Netherlands)
• 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
• Date of first enrolment: 21/04/2004
• Target sample size: 800
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN73187232
• Study type: Interventional
• Study design: Multicentre randomised active-controlled parallel group trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

Netherlands

Contacts

• Name: Arjan van Zuilen

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic renal insufficiency, renal transplant, cardiovascular disease
Urological and Genital Diseases
Renal insufficiency

Intervention(s)

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(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(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

Secondary ID(s)

2003B261; NTR22

Source(s) of Monetary Support

Dutch Kidney Foundation (Nierstichting Nederland) (Netherlands) (ref: pv-01), Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands) (ref: 2003B261), Amgen (Netherlands), Pfizer (Netherlands), Genzyme (Netherlands)