Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
Study NCT ID:
NCT03550534
Status:
COMPLETED
Last Update Posted:
2018-06-08
First Post:
2018-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effectiveness and Safety of Calcium Carbonate in Chronic Kidney Disease With Normophosphatemia
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002119', 'term': 'Calcium Carbonate'}], 'ancestors': [{'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2016-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-07', 'studyFirstSubmitDate': '2018-05-22', 'studyFirstSubmitQcDate': '2018-06-07', 'lastUpdatePostDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Fibroblast Growth Factor 23 (FGF-23)', 'timeFrame': '12 weeks', 'description': 'Serum FGF23 (pg/ml) as cardiovascular risk factor in chronic kidney disease (CKD) was measured and compared between 2 groups before and after intervention'}], 'secondaryOutcomes': [{'measure': 'Serum Calcium Level', 'timeFrame': '12 weeks', 'description': 'Serum calcium level (mg/dl) was measured and compared between 2 groups before and after intervention'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Calcium carbonate', 'Chronic kidney disease', 'Normophosphatemia', 'FGF23', 'Phosphate binder'], 'conditions': ['Chronic Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '21673295', 'type': 'RESULT', 'citation': 'Isakova T, Xie H, Yang W, Xie D, Anderson AH, Scialla J, Wahl P, Gutierrez OM, Steigerwalt S, He J, Schwartz S, Lo J, Ojo A, Sondheimer J, Hsu CY, Lash J, Leonard M, Kusek JW, Feldman HI, Wolf M; Chronic Renal Insufficiency Cohort (CRIC) Study Group. Fibroblast growth factor 23 and risks of mortality and end-stage renal disease in patients with chronic kidney disease. JAMA. 2011 Jun 15;305(23):2432-9. doi: 10.1001/jama.2011.826.'}, {'type': 'RESULT', 'citation': 'Martin K, Floege J, Ketteler M. Bone and mineral metabolism in chronic kidney disease. In: Johnson R, Feehally J, Floege J, editors. Comprehensive clinical nephrology. Fifth edition. Philadelphia: Saunders; 2015. p. 984-7.'}, {'type': 'RESULT', 'citation': 'Ketteler M, Leonard M. KDIGO 2016 Clinical practice guideline update on diagnosis, evaluation, prevention, and treatment of CKD-MBD. Off J Int Soc Nephrol. 2016;(August):1-45'}, {'pmid': '19751895', 'type': 'RESULT', 'citation': "Prakash S, O'Hare AM. Interaction of aging and chronic kidney disease. Semin Nephrol. 2009 Sep;29(5):497-503. doi: 10.1016/j.semnephrol.2009.06.006."}, {'pmid': '18670407', 'type': 'RESULT', 'citation': 'Iseki K. Gender differences in chronic kidney disease. Kidney Int. 2008 Aug;74(4):415-7. doi: 10.1038/ki.2008.261.'}, {'type': 'RESULT', 'citation': 'Perhimpunan Nefrologi Indonesia. 8th Report of Indonesian Renal Registry. Jakarta; 2015'}, {'pmid': '22638939', 'type': 'RESULT', 'citation': "Bayliss G, Weinrauch LA, D'Elia JA. Pathophysiology of obesity-related renal dysfunction contributes to diabetic nephropathy. Curr Diab Rep. 2012 Aug;12(4):440-6. doi: 10.1007/s11892-012-0288-1."}, {'pmid': '20089497', 'type': 'RESULT', 'citation': 'Langman CB, Cannata-Andia JB. Calcium in chronic kidney disease: myths and realities. Introduction. Clin J Am Soc Nephrol. 2010 Jan;5 Suppl 1:S1-2. doi: 10.2215/CJN.06140809. No abstract available.'}, {'pmid': '17656479', 'type': 'RESULT', 'citation': 'Fliser D, Kollerits B, Neyer U, Ankerst DP, Lhotta K, Lingenhel A, Ritz E, Kronenberg F; MMKD Study Group; Kuen E, Konig P, Kraatz G, Mann JF, Muller GA, Kohler H, Riegler P. Fibroblast growth factor 23 (FGF23) predicts progression of chronic kidney disease: the Mild to Moderate Kidney Disease (MMKD) Study. J Am Soc Nephrol. 2007 Sep;18(9):2600-8. doi: 10.1681/ASN.2006080936. Epub 2007 Jul 26.'}, {'pmid': '23391319', 'type': 'RESULT', 'citation': 'Soriano S, Ojeda R, Rodriguez M, Almaden Y, Rodriguez M, Martin-Malo A, Aljama P. The effect of phosphate binders, calcium and lanthanum carbonate on FGF23 levels in chronic kidney disease patients. Clin Nephrol. 2013 Jul;80(1):17-22. doi: 10.5414/CN107764.'}, {'pmid': '21771755', 'type': 'RESULT', 'citation': 'Shigematsu T, Negi S; COLC Research Group. Combined therapy with lanthanum carbonate and calcium carbonate for hyperphosphatemia decreases serum FGF-23 level independently of calcium and PTH (COLC Study). Nephrol Dial Transplant. 2012 Mar;27(3):1050-4. doi: 10.1093/ndt/gfr388. Epub 2011 Jul 19.'}, {'pmid': '19965540', 'type': 'RESULT', 'citation': 'Oliveira RB, Cancela AL, Graciolli FG, Dos Reis LM, Draibe SA, Cuppari L, Carvalho AB, Jorgetti V, Canziani ME, Moyses RM. Early control of PTH and FGF23 in normophosphatemic CKD patients: a new target in CKD-MBD therapy? Clin J Am Soc Nephrol. 2010 Feb;5(2):286-91. doi: 10.2215/CJN.05420709. Epub 2009 Nov 12.'}, {'pmid': '22822075', 'type': 'RESULT', 'citation': 'Block GA, Wheeler DC, Persky MS, Kestenbaum B, Ketteler M, Spiegel DM, Allison MA, Asplin J, Smits G, Hoofnagle AN, Kooienga L, Thadhani R, Mannstadt M, Wolf M, Chertow GM. Effects of phosphate binders in moderate CKD. J Am Soc Nephrol. 2012 Aug;23(8):1407-15. doi: 10.1681/ASN.2012030223. Epub 2012 Jul 19.'}, {'pmid': '19056618', 'type': 'RESULT', 'citation': 'Sprague SM, Abboud H, Qiu P, Dauphin M, Zhang P, Finn W. Lanthanum carbonate reduces phosphorus burden in patients with CKD stages 3 and 4: a randomized trial. Clin J Am Soc Nephrol. 2009 Jan;4(1):178-85. doi: 10.2215/CJN.02830608. Epub 2008 Dec 3.'}, {'pmid': '23254903', 'type': 'RESULT', 'citation': 'Hill KM, Martin BR, Wastney ME, McCabe GP, Moe SM, Weaver CM, Peacock M. Oral calcium carbonate affects calcium but not phosphorus balance in stage 3-4 chronic kidney disease. Kidney Int. 2013 May;83(5):959-66. doi: 10.1038/ki.2012.403. Epub 2012 Dec 19.'}]}, 'descriptionModule': {'briefSummary': 'Background: Patient with stage 3 or 4 chronic kidney disease (CKD) usually has normal level of serum phosphate, due to increased serum fibroblast growth factor-23 (FGF23) level that resulted in increased phosphate urine excretion. On the other hand, serum FGF23 elevation was related to CKD progression, vascular calcification, cardiomegaly, and mortality. This double blind, randomized controlled trial study was conducted to evaluate effectiveness and safety of calcium carbonate administration in stage 3 or 4 CKD patients with normophosphatemia.\n\nHypothesis: Calcium carbonate administration is effective and safe in chronic kidney disease (CKD) with normophosphatemia.', 'detailedDescription': 'Cardiovascular disease is the most cause of mortality of chronic kidney disease (CKD) patients. As CKD progresses, the prevalence of cardiovascular disease also increased. Beside traditional cardiovascular risk factor that the investigators have known, some non-traditional cardiovascular risk factors were reported to be associated with cardiovascular disease in CKD patients, which one of them was increased level of fibroblast growth factor-23 (FGF23).\\[1,2\\]\n\nFGF23 reduces production of 1,25-vitamin D3 and expression of sodium-phosphate cotransport, and also excretes phosphate through urine. In healthy and CKD population, increased phosphate level resulted in increased production of FGF23. Normophosphatemia state in early to moderate stage of CKD was reported due to body compensation by increasing the level of FGF23. On the other hand, increased serum FGF23 level was related to CKD progression, cardiomegaly, vascular calcification, and mortality.\\[1\\] There are several ways to prevent hyperphosphatemia, such as low phosphor intake, phosphate binder administration, and adequate dialysis.\\[3\\]\n\nPhosphate binder was reported to give positive effects in CKD patients with hyperphosphatemia. Studies which investigated the use of phosphate binder in CKD patients with normophosphatemia to decrease FGF23 were still limited and the result was controversial.\\[1\\]\n\nTherefore, this double blind, randomized controlled trial study investigated the effectiveness and safety of calcium carbonate in early to moderate CKD patients with normophosphatemia in lowering FGF23 levels. Study participant were randomized to receive calcium carbonate or placebo for 12 weeks. Before and after intervention, blood and urine sample were taken to examine serum FGF23, serum phosphate, urine phosphate, ionized calcium, serum calcium, urea, creatinine, estimated glomerular filtration rate (eGFR), and albumin. Effectiveness of calcium carbonate administration was indicated by serum FGF23, while safety was indicated by serum calcium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage 3 or 4 chronic kidney disease patient that visit nephrology or endocrinology outpatient clinic of dr. Cipto Mangunkusumo Hospital\n* Normal level of serum phosphate\n* Agreed to join in this study\n\nExclusion Criteria:\n\n* Subjects with BMI \\< 18.5 kg/m2 or \\> 30 kg/m2\n* Consume drugs which may interfere bone mineral metabolism'}, 'identificationModule': {'nctId': 'NCT03550534', 'briefTitle': 'The Effectiveness and Safety of Calcium Carbonate in Chronic Kidney Disease With Normophosphatemia', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'The Effectiveness and Safety of Calcium Carbonate in Chronic Kidney Disease With Normophosphatemia: A Double Blind, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '198/UN2.F1/ETIK/2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Calcium Carbonate', 'description': 'Calcium carbonate 3 x 500 mg was given to 23 study participants for 12 weeks', 'interventionNames': ['Drug: Calcium Carbonate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo oral capsule', 'description': 'Placebo oral capsule 3 x 1 was given to 23 study participants for 12 weeks', 'interventionNames': ['Drug: Placebo oral capsule']}], 'interventions': [{'name': 'Calcium Carbonate', 'type': 'DRUG', 'description': 'Calcium carbonate was obtained from Pharmacy Department, Faculty of Medicine, University of Indonesia. Subjects were randomized to receive calcium carbonate or placebo for 12 weeks.', 'armGroupLabels': ['Calcium Carbonate']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'description': 'Placebo oral capsule was also obtained from Pharmacy Department, Faculty of Medicine, University of Indonesia. Subjects were randomized to receive calcium carbonate or placebo for 12 weeks.', 'armGroupLabels': ['Placebo oral capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'dr. Cipto Mangunkusumo Hospital', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'overallOfficials': [{'name': 'Pringgodigdo Nugroho, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia University'}, {'name': 'Maruhum Bonar H. Marbun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia University'}, {'name': 'Bella Yunita, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia University'}, {'name': 'Cindy Astrella, MD, BMedSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dr Cipto Mangunkusumo General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Dialysis Unit, Dr Cipto Mangunkusumo General Hospital', 'investigatorFullName': 'Pringgodigdo Nugroho, MD', 'investigatorAffiliation': 'Indonesia University'}}}}