Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-03-01 @ 3:22 PM
Study NCT ID:
NCT02649205
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2015-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study on Chronic Kidney Disease Treatment With a Ketosteril Supplemented Protein-restricted Diet
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-16', 'studyFirstSubmitDate': '2015-12-17', 'studyFirstSubmitQcDate': '2016-01-05', 'lastUpdatePostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient compliance to Ketosteril (number of tablets taken; patient-reported)', 'timeFrame': 'Daily, for a total of 12 months', 'description': 'This is an observational study aiming to characterise the patient profile and contemporary treatment of pre-dialytic chronic kidney disease (CKD) in patients receiving a restricted protein diet supplemented with Ketosteril® . There is no distinction between primary and secondary outcome measures in the observational plan, and only routine procedures are documented.'}], 'secondaryOutcomes': [{'measure': 'Patient compliance to diet (protein and energy intake, based on a routine 3-day food diary)', 'timeFrame': 'Monthly starting 1 month after enrolment, for a total of 12 months', 'description': 'This is an observational study aiming to characterise the patient profile and contemporary treatment of pre-dialytic chronic kidney disease (CKD) in patients receiving a restricted protein diet supplemented with Ketosteril® . There is no distinction between primary and secondary outcome measures in the observational plan, and only routine procedures are documented.'}, {'measure': 'CKD stage (according to KDIGO guideline)', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Presence of comorbidities', 'timeFrame': 'At baseline', 'description': 'e.g., diabetes, hypertension, metabolic syndrome'}, {'measure': 'Serum creatinine', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': '24h urinary protein', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Urinary microalbumin', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Serum urea', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Creatinine clearance', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Glomerular filtration rate (GFR)', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Estimated glomerular filtration rate (eGFR)', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Fasting blood glucose', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Fasting plasma glucose', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'HbA1c', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Serum triglyceride', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Serum cholesterol', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Serum high-density lipoprotein (HDL)', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Serum low-density lipoprotein (LDL)', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Serum calcium', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Serum phosphate', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Serum parathyroid hormone', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Weight', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment', 'description': 'Total body weight'}, {'measure': 'Skinfold thickness', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Serum total protein', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Serum albumin', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Serum prealbumin', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Body mass index', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Subjective Global Assessment', 'timeFrame': 'At baseline and 3, 6, 9 and 12 months after enrolment', 'description': 'Final result/score to be reported'}, {'measure': 'Decline in eGFR', 'timeFrame': 'At 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Worsening of CKD stage', 'timeFrame': 'At 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Start of dialysis', 'timeFrame': 'At 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Presence of a 50% reduction in eGFR', 'timeFrame': 'At 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Serum bicarbonate', 'timeFrame': 'At baseline and 3, 6 and 12 months after enrolment'}, {'measure': 'Serum haemoglobin', 'timeFrame': 'At baseline and 3, 6 and 12 months after enrolment'}, {'measure': 'Serum potassium', 'timeFrame': 'At baseline and 3, 6 and 12 months after enrolment'}, {'measure': 'Reported nausea and vomiting', 'timeFrame': 'At baseline and 3, 6 and 12 months after enrolment'}, {'measure': 'Presence of concomitant disease', 'timeFrame': 'At 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Administration of concomitant medication', 'timeFrame': 'At 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Discontinuation of diet and Ketosteril with the reasons for discontinuation as reported by the investigator', 'timeFrame': 'Monthly starting at 1 month after enrolment for up to 12 months'}, {'measure': 'Acceptance of diet as documented in the patient diary', 'timeFrame': 'Daily for up to 12 months'}, {'measure': 'Appetite change as documented in the patient diary', 'timeFrame': 'Daily for up to 12 months'}, {'measure': 'Change of food intake as documented in the patient diary', 'timeFrame': 'Daily for up to 12 months'}, {'measure': 'Adverse events including adverse drug reactions and serious adverse events', 'timeFrame': 'At 3, 6, 9 and 12 months after enrolment'}, {'measure': 'Blood pressure', 'timeFrame': 'At baseline and 3, 6, 9 and at 12 months after enrolment'}, {'measure': 'Heart rate', 'timeFrame': 'At baseline and 3, 6, 9 and at 12 months after enrolment'}, {'measure': 'Body temperature', 'timeFrame': 'At baseline and 3, 6, 9 and at 12 months after enrolment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterise the patient and disease profile under the influence of a protein-restricted diet supplemented with keto acids/amino acids (KA/AA), focusing on the progression of chronic renal insufficiency, calcium and phosphorus metabolism, nutritional status, patient compliance to diet and Ketosteril intake as well as the persistent dietary education to ensure compliance in a large group of pre-dialysis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pre-dialytic chronic kidney disease patients treated at nephrology units of selected hospitals in Czech Republic, Hungary and Romania.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consent\n* non-dialyzed patients with CKD\n* indication for Ketosteril according to Summary of Product Characteristics (SmPC), including a glomerular filtration rate (GFR) \\< 25 mL/min\n* accepted supplemented protein-restricted diet and newly starting with Ketosteril (treatment naïve, i.e., never treated with Ketosteril before)\n* adult patients ≥ 18 years\n\nExclusion Criteria:\n\n* active cancer diseases\n* pregnancy or breast feeding\n* hypersensitivity to active substances or to any of the excipients in Ketosteril\n* hypercalcaemia\n* major disorder of amino acid metabolism, e.g., hereditary diseases\n* participation in any clinical trial with an investigational drug within 30 days prior to start of study or during the study\n* illiteracy or incapability to read or write'}, 'identificationModule': {'nctId': 'NCT02649205', 'briefTitle': 'Observational Study on Chronic Kidney Disease Treatment With a Ketosteril Supplemented Protein-restricted Diet', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Kabi'}, 'officialTitle': 'Characterisation of Patient Profile and Contemporary Treatment of Pre-dialytic Chronic Kidney Disease (CKD) in Patients Receiving a Restricted Protein Diet Supplemented With Ketosteril® - a Drug Utilisation Study (DUS)', 'orgStudyIdInfo': {'id': 'Keto-023-CNI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic kidney disease (pre-dialysis)', 'description': 'Observational study: Supplemented protein-restricted diet', 'interventionNames': ['Other: Observational study: Supplemented protein-restricted diet']}], 'interventions': [{'name': 'Observational study: Supplemented protein-restricted diet', 'type': 'OTHER', 'description': 'Observational study: Supplemented protein-restricted diet', 'armGroupLabels': ['Chronic kidney disease (pre-dialysis)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2481', 'city': 'Velence', 'country': 'Hungary', 'facility': 'Velencei-tavi Kistérségi Járóbeteg Szakellátó Közhasznú Nonprofit Kft', 'geoPoint': {'lat': 47.23855, 'lon': 18.65484}}], 'overallOfficials': [{'name': 'Gábor Zakar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Velencei-tavi Kistérségi Járóbeteg Szakellátó Közhasznú Nonprofit Kft'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Kabi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}