Official Title: “Circadian Rhythm of Erythropoietin and Melatonin in Patients With Various Degrees of Renal Insufficiency”

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.

Study Type: Observational

Study Design: Case-Only, Prospective

Study Primary Completion Date: June 2008

Arms, Groups and Cohorts in this Clinical Trial

• : A
  • MDRD 10-30
• : B
  • MDRD 30-60
• : C
  • MDRD 60-80
• : D
  • MDRD > 80

Primary Measures

• existence of circadian rhythm of Erythropoietin and Melatonin
  • Time Frame: 24 hours
    Safety Issue?: No

Secondary Measures

• existence of a circadian rhythm of cortisol and IGF-1
  • Time Frame: 24 hours
    Safety Issue?: No
• Relationship between temperature and melatonin. Relationship between blood pressure and erythropoietin
  • Time Frame: 24 hours
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Meander Medical Center

Overall Clinical Trial Officials and Contacts

Carlo AJM Gaillard, MD PhD Study Chair Meander Medical Center  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00698360

Study ID Number: CREAM 1

ClinicalTrials.gov Identifier: NCT00698360

Health Authority: Netherlands: Medical Ethics Review Committee (METC)