Circadian Rhythm of Erythropoietin And Melatonin in Renal Disease

Study Overview
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Brief Summary
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Rationale: Investigation of the circadian rhythm of erythropoietin and melatonin in patients with various degrees of renal insufficiency Objectives: Primary objective: Is there a circadian rhythm of epo and melatonin in patients with various degrees of renal insufficiency? Primary Objective: Is there a circadian rhythm of epo and melatonin in patients with various degrees of renal insufficiency compared to patients with a normal renal function? Secondary Objective: Is there a circadian rhythm of cortisol and IGF in patients with various degrees of renal insufficiency? Secondary Objective: Is there a circadian rhythm of cortisol and IGF in patients with various degrees of renal insufficiency compared to patients with a normal renal function? Study design: Comparative study in 4 groups with various degrees of renal insufficiency, duration for each patient 24 hrs. Total duration of study 12 months, patients admitted to the hospital (on nursing ward) Study population: Patients with various degrees of renal insufficiency Main study parameters/endpoints: Analysis of the existence of a circadian rhythm in patients with a normal renal function and in patients with variable degrees of renal insufficiency Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Better knowledge of the circadian rhythm in renal insufficiency. This could lead to a more efficient administration of erythropoietin and melatonin in the future. Extent of burden is 1 venapunction for placement of infusion needle, the withdrawal of 11 times 5 ml blood in 24 hrs, continuous measurement of body temperature via capsule, 24-hour continuous ambulant blood pressure monitoring.

Official Title
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Circadian Rhythm of Erythropoietin and Melatonin in Patients With Various Degrees of Renal Insufficiency

Conditions
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Chronic Kidney Disease

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patient with various degrees of renal insufficiency, stable creatinin clearance: minimum 10 ml/min (measured with MDRD), admitted to our hospital Informed Consent Man/Women between 18 and 85 years Understanding and knowledge of the dutch language Exclusion criteria: Instable angina pectoris, heart failure NYHA class IV Therapy with erythropoetin, melatonin and hypnotics Acute renal failure or rapidly progressive glomerulonephritis Bleeding or hemolysis as a cause of anemia Deficiency of iron, folate and/or vitamin B12 Presence of chronic inflammatory disease or clinically significant infection Hemoglobinopathies Alcohol and/or drug abuse Enrolment in another study Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>MDRD 10-30 | |
| B<br>MDRD 30-60 | |
| C<br>MDRD 60-80 | |
| D<br>MDRD > 80 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| existence of circadian rhythm of Erythropoietin and Melatonin |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| existence of a circadian rhythm of cortisol and IGF-1 |  | 24 hours | 
| Relationship between temperature and melatonin. Relationship between blood pressure and erythropoietin |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic kidney disease, melatonin, erythropoietin, circadian rhythm