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

Meander Medical Center

Status: Completed

Conditions: Chronic Kidney Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00698360

R-07.03M

CREAM 1

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

34 participants in 4 patient groups

A

Description:

MDRD 10-30

B

Description:

MDRD 30-60

C

Description:

MDRD 60-80

D

Description:

MDRD \> 80