Circadian Rhythm of Erythropoietin And Melatonin in Renal Disease (CREAM 1)

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 Overview

• Status: Completed
• Conditions: Chronic Kidney Disease

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• Netherlands
  • Amersfoort, Netherlands, 3818 ES
    • Meander Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
A; MDRD 10-30
B; MDRD 30-60
C; MDRD 60-80
D; MDRD > 80

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
existence of circadian rhythm of Erythropoietin and Melatonin	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Meander Medical Center
• Collaborators: Hoffmann-La Roche; Stichting Bijstand, Meander Medical Center
• Investigators: Study Chair: Carlo AJM Gaillard, MD PhD, Meander Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: June 13, 2008
• First Submitted That Met QC Criteria: June 16, 2008
• First Posted (Estimate): June 17, 2008

Study Record Updates

• Last Update Posted (Estimate): June 17, 2008
• Last Update Submitted That Met QC Criteria: June 16, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: melatonin; chronic kidney disease; erythropoietin; circadian rhythm
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: CREAM 1; R-07.03M