Circadian Rhythm of Erythropoietin And Melatonin in Renal Disease
NCT ID: NCT00698360
Last Updated: 2008-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
34 participants
OBSERVATIONAL
2007-07-31
2008-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
MDRD 10-30
No interventions assigned to this group
B
MDRD 30-60
No interventions assigned to this group
C
MDRD 60-80
No interventions assigned to this group
D
MDRD \> 80
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Informed Consent
* Man/Women between 18 and 85 years
* Understanding and knowledge of the dutch language
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stichting Bijstand, Meander Medical Center
UNKNOWN
Hoffmann-La Roche
INDUSTRY
Meander Medical Center
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carlo AJM Gaillard, MD PhD
Role: STUDY_CHAIR
Meander Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Meander Medical Center
Amersfoort, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
R-07.03M
Identifier Type: -
Identifier Source: secondary_id
CREAM 1
Identifier Type: -
Identifier Source: org_study_id