Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
Study NCT ID:
NCT00374712
Status:
TERMINATED
Last Update Posted:
2007-11-08
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Klotho Gene Polymorphism in Dialyzed Patients With Hyperphosphatemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D054559', 'term': 'Hyperphosphatemia'}, {'id': 'D012080', 'term': 'Chronic Kidney Disease-Mineral and Bone Disorder'}], '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'}, {'id': 'D010760', 'term': 'Phosphorus Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012279', 'term': 'Rickets'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}, {'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'whyStopped': 'terminated', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-06', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2006-09-08', 'lastUpdatePostDateStruct': {'date': '2007-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-11', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phosphate', 'Dialysis', 'Klotho', 'Hemodialysis'], 'conditions': ['Chronic Kidney Disease', 'End Stage Renal Disease', 'Hyperphosphatemia', 'Renal Osteodystrophy']}, 'referencesModule': {'references': [{'pmid': '15930998', 'type': 'RESULT', 'citation': 'Prie D, Beck L, Urena P, Friedlander G. Recent findings in phosphate homeostasis. Curr Opin Nephrol Hypertens. 2005 Jul;14(4):318-24. doi: 10.1097/01.mnh.0000172716.41853.1e.'}]}, 'descriptionModule': {'briefSummary': 'Patients with chronic kidney disease (CKD) and those with end-stage renal disease (ESRD) undergoing renal replacement therapies show elevated serum phosphate levels which predispose them to cardiovascular calcifications and high risks of death from cardiovascular diseases. However, in certain patients hyperphosphatemia is not related to dialysis insufficiency, excessive daily dietary phosphorus intake or high serum parathyroid hormone (PTH) levels, suggesting that other mechanisms could be involved. Transgenic mice lacking the klotho gene showed a phenotype which resembles that of dialyzed ESRD patients, in the sense that they have hyperphosphatemia, vascular calcifications, and a short lifespan. This study will analyze whether functional polymorphisms or variants in the human klotho gene are associated with hyperphosphatemia in these patients.', 'detailedDescription': 'The entire coding region of the klotho gene will be sequenced looking for functional variants and polymorphisms that differentiate two groups of adult dialyzed ESRD patients, matched for age and gender, and with comparable values for dialysis dose and daily protein intake. These two groups consist of one group of 20 adult, dialyzed patients with serum phosphate levels \\> 2.50 mM compared to another group of 20 adult, dialyzed ESRD patients with serum phosphate levels \\< 1.50 mM. The results of this study will allow to determine whether there is a relationship between extreme hyperphosphatemia and klotho gene polymorphisms in dialysed ESRD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult, end-stage renal disease patients treated by standard hemodialysis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup 1\n\n* Stable hemodialysis patients for at least 3 months\n* Phosphatemia \\> 2.5 mM\n* Kt/V \\> 1.2\n* Total weekly phosphate removal \\> 75 millimoles\n\nGroup 2\n\n* Stable hemodialysis patients for at least 3 months\n* Phosphatemia \\< 1.5 mM\n* Kt/V \\> 1.2\n* Total weekly phosphate removal \\> 25 millimoles\n\nExclusion Criteria:\n\n* Age \\> 80 years\n* Insufficient dialysis dose (Kt/V \\< 1.2)\n* Total weekly phosphate removal \\< 25 mM\n* Problems with vascular access for hemodialysis (central catheter, arteriovenous \\[A-V\\] fistula dysfunction)\n* Methods of dialysis different than the classical hemodialysis (peritoneal, hemofiltration, or hemodiafiltration with or without acetate)\n* Intolerance or allergy to ARYLANE M9 dialyzers\n* Hypocalcemia \\< 2.0 mmol/liter\n* Hypophosphatemia \\< 0.6 mmol/liter\n* Daily protein intake \\< 0.6 g/kg/j\n* Parathyroidectomy at least 3 months prior to the study\n* Evolutive neoplasia with or without secondary lytic bone lesions\n* Intestinal malabsorption\n* Alcoholism\n* Corticotherapy\n* Treatment by bisphosphonates, fluor or recombinant PTH\n* Malnutrition (body mass index \\[BMI\\] \\< 15)\n* Amputation of lower members (\\> 10% of total body)\n* Prolonged immobilization\n* Secondary hyperparathyroidism (PTH \\> 1400 pg/ml)\n* Vitamin D deficiency (25OHD3 \\< 10 ng/ml)'}, 'identificationModule': {'nctId': 'NCT00374712', 'briefTitle': 'Klotho Gene Polymorphism in Dialyzed Patients With Hyperphosphatemia', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Study of Klotho Gene Polymorphisms in the Regulation of Serum Phosphate Levels in Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'P031010'}, 'secondaryIdInfos': [{'id': 'CRC 03161'}]}, 'contactsLocationsModule': {'locations': [{'zip': '93300', 'city': 'Aubervilliers', 'country': 'France', 'facility': "Clinique de l'Orangerie - Service de Néphrologie et Dialyse", 'geoPoint': {'lat': 48.91667, 'lon': 2.38333}}], 'overallOfficials': [{'name': 'Pablo URENA TORRES, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Clinique de l'Orangerie, France"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}]}}}