Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 4:36 PM
Study NCT ID:
NCT00698360
Status:
COMPLETED
Last Update Posted:
2008-06-17
First Post:
2008-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Circadian Rhythm of Erythropoietin And Melatonin in Renal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-16', 'studyFirstSubmitDate': '2008-06-13', 'studyFirstSubmitQcDate': '2008-06-16', 'lastUpdatePostDateStruct': {'date': '2008-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'existence of circadian rhythm of Erythropoietin and Melatonin', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'existence of a circadian rhythm of cortisol and IGF-1', 'timeFrame': '24 hours'}, {'measure': 'Relationship between temperature and melatonin. Relationship between blood pressure and erythropoietin', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic kidney disease', 'melatonin', 'erythropoietin', 'circadian rhythm'], 'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'Rationale: Investigation of the circadian rhythm of erythropoietin and melatonin in patients with various degrees of renal insufficiency\n\nObjectives:\n\nPrimary objective: Is there a circadian rhythm of epo and melatonin in patients with various degrees of renal insufficiency?\n\nPrimary 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?\n\nSecondary Objective: Is there a circadian rhythm of cortisol and IGF in patients with various degrees of renal insufficiency?\n\nSecondary 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?\n\nStudy 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)\n\nStudy population: Patients with various degrees of renal insufficiency\n\nMain 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\n\nNature 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.\n\nExtent 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with various degrees of renal insufficiency, admitted to Meander Medical Center\n\n* A: Patients with renal insufficiency (clearance 10-30 ml/min)\n* B: Patients with renal insufficiency (clearance 30-60 ml/min)\n* C: Patients with renal insufficiency (clearance 60-80 ml/min)\n* D: Patients with normal renal function (clearance \\> 80 ml/min)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patient with various degrees of renal insufficiency, stable creatinin clearance: minimum 10 ml/min (measured with MDRD), admitted to our hospital\n* Informed Consent\n* Man/Women between 18 and 85 years\n* Understanding and knowledge of the dutch language\n\nExclusion criteria:\n\n* Instable angina pectoris, heart failure NYHA class IV\n* Therapy with erythropoetin, melatonin and hypnotics\n* Acute renal failure or rapidly progressive glomerulonephritis\n* Bleeding or hemolysis as a cause of anemia\n* Deficiency of iron, folate and/or vitamin B12\n* Presence of chronic inflammatory disease or clinically significant infection\n* Hemoglobinopathies\n* Alcohol and/or drug abuse\n* Enrolment in another study\n* Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures'}, 'identificationModule': {'nctId': 'NCT00698360', 'acronym': 'CREAM 1', 'briefTitle': 'Circadian Rhythm of Erythropoietin And Melatonin in Renal Disease', 'organization': {'class': 'OTHER', 'fullName': 'Meander Medical Center'}, 'officialTitle': 'Circadian Rhythm of Erythropoietin and Melatonin in Patients With Various Degrees of Renal Insufficiency', 'orgStudyIdInfo': {'id': 'CREAM 1'}, 'secondaryIdInfos': [{'id': 'R-07.03M'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'MDRD 10-30'}, {'label': 'B', 'description': 'MDRD 30-60'}, {'label': 'C', 'description': 'MDRD 60-80'}, {'label': 'D', 'description': 'MDRD \\> 80'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3818 ES', 'city': 'Amersfoort', 'country': 'Netherlands', 'facility': 'Meander Medical Center', 'geoPoint': {'lat': 52.155, 'lon': 5.3875}}], 'overallOfficials': [{'name': 'Carlo AJM Gaillard, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Meander Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meander Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stichting Bijstand, Meander Medical Center', 'class': 'UNKNOWN'}, {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Meander Medical Center'}}}}