NCT00698360|Completed
Circadian Rhythm of Erythropoietin And Melatonin in Renal Disease
CREAM 1
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CREAM 1
Sponsor study identifier
Secondary identifiers
observational
34
1 country
1
Study Start
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2008
Actual (reported)Study Completion
June 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2008
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
June 2008
Actual (reported)June 2008
Actual (reported)June 13, 2008
Actual (reported)June 17, 2008
Actual (reported)existence of circadian rhythm of Erythropoietin and Melatonin
24 hours
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
MDRD 10-30
MDRD 30-60
MDRD 60-80
MDRD \> 80
Patients with various degrees of renal insufficiency, admitted to Meander Medical Center * A: Patients with renal insufficiency (clearance 10-30 ml/min) * B: Patients with renal insufficiency (clearance 30-60 ml/min) * C: Patients with renal insufficiency (clearance 60-80 ml/min) * D: Patients with normal renal function (clearance \> 80 ml/min)
Meander Medical Center
Amersfoort, 3818 ES, Netherlands
serum
Carlo AJM Gaillard, MD PhD
Meander Medical Center
34 participants (actual enrollment reported by the registry).
First Submitted
June 13, 2008
First Posted
June 17, 2008
Study Start
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
June 2008
Actual (reported)Study Completion
June 2008
Actual (reported)Last Updated
June 17, 2008
Record last verified: 2008-06
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Source: ClinicalTrials.gov.
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