Circadian Rhythm of Erythropoietin And Melatonin in Renal Disease

NCT00698360 | Completed

• 2 other identifiers: CREAM 1R-07.03M
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease

Keywords

chronic kidney disease; melatonin; erythropoietin; circadian rhythm

Outcome Measures

Primary Outcomes (1)

• existence of circadian rhythm of Erythropoietin and Melatonin

  24 hours

Secondary Outcomes (2)

• 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

Study Arms (4)

A

MDRD 10-30

B

MDRD 30-60

C

MDRD 60-80

D

MDRD \> 80

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meander Medical Center: lead
• Stichting Bijstand, Meander Medical Center: collaborator
• Hoffmann-La Roche: collaborator

Study Sites (1)

Meander Medical Center

Amersfoort, 3818 ES, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlo AJM Gaillard, MD PhD

  Meander Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 13, 2008
• First Posted: June 17, 2008
• Study Start: July 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 17, 2008

Record last verified: 2008-06

Locations

NL (1)