Circadian Rhythm of Erythropoietin And Melatonin in Renal Disease

Chronic Kidney Disease Clinical Trial

— CREAM 1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00698360
• Other study ID #: CREAM 1
• Secondary ID: R-07.03M
• Status: Completed
• Phase: N/A
• First received: June 13, 2008
• Last updated: June 16, 2008
• Start date: July 2007
• Est. completion date: June 2008

Study information

• Verified date: June 2008
• Source: Meander Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Netherlands	Meander Medical Center	Amersfoort

Sponsors (3)

Lead Sponsor	Collaborator
Meander Medical Center	Hoffmann-La Roche, Stichting Bijstand, Meander Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	existence of circadian rhythm of Erythropoietin and Melatonin		24 hours	No
Secondary	existence of a circadian rhythm of cortisol and IGF-1		24 hours	No
Secondary	Relationship between temperature and melatonin. Relationship between blood pressure and erythropoietin		24 hours	No