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

Not Applicable
Completed
Conditions
Chronic renal insufficiency, renal transplant, cardiovascular disease
Urological and Genital Diseases
Renal insufficiency
Registration Number
ISRCTN73187232
Lead Sponsor
niversity Medical Centre Utrecht (UMCU) (Netherlands)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
800
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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Assessment of cardiovascular morbidity (comprised of myocardial infarction, stroke and all vascular interventions, including amputation of an extremity due to vascular insufficiency)<br>2. Cardiovascular mortality<br>3. All cause mortality
Secondary Outcome Measures
NameTimeMethod
1. Decline in renal function, this will be established by annual measurement of creatinine clearance by 24-hour urine measurements<br>2. Quality of life, will be assessed using a validated questionnaire<br>3. Markers of vascular damage: aortic pulse wave velocity, carotid intimal media thickness and the ankle-brachial index
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