Circadian Rhythm of Erythropoietin And Melatonin in Renal Disease - Full Text View

Sponsors and Collaborators:	Meander Medical Center Stichting Bijstand, Meander Medical Center Hoffmann-La Roche
Information provided by:	Meander Medical Center
ClinicalTrials.gov Identifier:	NCT00698360

Purpose

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

Drug Information available for: Epoetin alfa Erythropoietin Melatonin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Circadian Rhythm of Erythropoietin and Melatonin in Patients With Various Degrees of Renal Insufficiency

Further study details as provided by Meander Medical Center:

Primary Outcome Measures:

existence of circadian rhythm of Erythropoietin and Melatonin [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

existence of a circadian rhythm of cortisol and IGF-1 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Relationship between temperature and melatonin. Relationship between blood pressure and erythropoietin [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

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
B MDRD 30-60
C MDRD 60-80
D MDRD > 80

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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)

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698360

Locations

Netherlands
Meander Medical Center
Amersfoort, Netherlands, 3818 ES

Sponsors and Collaborators

Meander Medical Center

Stichting Bijstand, Meander Medical Center

Hoffmann-La Roche

Investigators

Study Chair:

Carlo AJM Gaillard, MD PhD

Meander Medical Center

More Information

Responsible Party:	( Meander Medical Center )
Study ID Numbers:	CREAM 1, R-07.03M
Study First Received:	June 13, 2008
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00698360
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Meander Medical Center:

chronic kidney disease
melatonin
erythropoietin
circadian rhythm

Study placed in the following topic categories:

Epoetin Alfa
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Melatonin
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Antioxidants
Molecular Mechanisms of Pharmacological Action
Hematinics
Therapeutic Uses
Physiological Effects of Drugs

Hematologic Agents
Central Nervous System Depressants
Protective Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009