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Sponsors and Collaborators: |
Meander Medical Center Stichting Bijstand, Meander Medical Center Hoffmann-La Roche |
Information provided by: | Meander Medical Center |
ClinicalTrials.gov Identifier: | NCT00698360 |
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.
Condition |
Chronic Kidney Disease |
ChemIDplus related topics: | Epoetin alfa Erythropoietin Melatonin |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Circadian Rhythm of Erythropoietin and Melatonin in Patients With Various Degrees of Renal Insufficiency |
serum
Enrollment: | 34 |
Study Start Date: | July 2007 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
A
MDRD 10-30
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B
MDRD 30-60
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C
MDRD 60-80
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D
MDRD > 80
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Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients with various degrees of renal insufficiency, admitted to Meander Medical Center
Inclusion criteria:
Exclusion criteria:
Netherlands | |||||
Meander Medical Center | |||||
Amersfoort, Netherlands, 3818 ES |
Meander Medical Center |
Stichting Bijstand, Meander Medical Center |
Hoffmann-La Roche |
Study Chair: | Carlo AJM Gaillard, MD PhD | Meander Medical Center |
Responsible Party: | ( Meander Medical Center ) |
Study ID Numbers: | CREAM 1, R-07.03M |
First Received: | June 13, 2008 |
Last Updated: | June 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00698360 |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
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