Circadian Rhythm of Erythropoietin And Melatonin in Renal Disease - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 13, 2008

Last Updated Date

June 16, 2008

Start Date ^†

July 2007

Current Primary Outcome Measures ^†

existence of circadian rhythm of Erythropoietin and Melatonin [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00698360 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

existence of a circadian rhythm of cortisol and IGF-1 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Relationship between temperature and melatonin. Relationship between blood pressure and erythropoietin [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Circadian Rhythm of Erythropoietin And Melatonin in Renal Disease

Official Title ^†

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

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.

Detailed Description

Study Phase

Study Type ^†

Observational

Study Design ^†

Case-Only, Prospective

Condition ^†

Chronic Kidney Disease

Intervention ^†

Study Arms / Comparison Groups

MDRD 10-30
MDRD 30-60
MDRD 60-80
MDRD > 80

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

June 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Netherlands

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00698360

Responsible Party

Meander Medical Center

Secondary IDs ^††

R-07.03M

Study Sponsor ^†

Meander Medical Center

Collaborators ^††

Stichting Bijstand, Meander Medical Center
Hoffmann-La Roche

Investigators ^†

Study Chair:

Carlo AJM Gaillard, MD PhD

Meander Medical Center

Information Provided By

Meander Medical Center

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.