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Circadian Rhythm of Erythropoietin And Melatonin in Renal Disease — CREAM 1  

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00698360
Study type Observational
Source Meander Medical Center
Contact
Status Completed
Phase N/A
Start date July 2007
Completion date June 2008
View Details
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