Clinical trial NCT00698360: Circadian Rhythm of Erythropoietin And Melatonin in Renal Disease
Official title: Circadian Rhythm of Erythropoietin and Melatonin in Patients With Various Degrees of Renal Insufficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease
melatonin
erythropoietin
circadian rhythm
Lead sponsor: Meander Medical Center
Sponsor class: OTHER
Collaborators: name: Stichting Bijstand, Meander Medical Center
name: Hoffmann-La Roche
First posted: 2008-06-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: existence of circadian rhythm of Erythropoietin and Melatonin
timeFrame: 24 hours
Secondary outcomes:
measure: existence of a circadian rhythm of cortisol and IGF-1
timeFrame: 24 hours
measure: Relationship between temperature and melatonin. Relationship between blood pressure and erythropoietin
timeFrame: 24 hours
Other outcomes:
Locations:
city: Amersfoort
country: Netherlands
facility: Meander Medical Center
Study officials:
affiliation: Meander Medical Center
name: Carlo AJM Gaillard, MD PhD
role: STUDY_CHAIR
References: