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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 13, 2008 | ||||
| Last Updated Date | June 16, 2008 | ||||
| Start Date ICMJE | July 2007 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
existence of circadian rhythm of Erythropoietin and Melatonin [ Time Frame: 24 hours ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00698360 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Circadian Rhythm of Erythropoietin And Melatonin in Renal Disease | ||||
| Official Title ICMJE | 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. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case-Only, Prospective | ||||
| Condition ICMJE | Chronic Kidney Disease | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 34 | ||||
| Completion Date | June 2008 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00698360 | ||||
| Responsible Party | Meander Medical Center | ||||
| Study ID Numbers ICMJE | CREAM 1, R-07.03M | ||||
| Study Sponsor ICMJE | Meander Medical Center | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Meander Medical Center | ||||
| Verification Date | June 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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