Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-02-20 @ 11:26 AM
Study NCT ID:
NCT01820832
Status:
UNKNOWN
Last Update Posted:
2013-03-29
First Post:
2013-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D011507', 'term': 'Proteinuria'}], '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': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002117', 'term': 'Calcitriol'}], 'ancestors': [{'id': 'D004100', 'term': 'Dihydroxycholecalciferols'}, {'id': 'D006887', 'term': 'Hydroxycholecalciferols'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-28', 'studyFirstSubmitDate': '2013-03-19', 'studyFirstSubmitQcDate': '2013-03-28', 'lastUpdatePostDateStruct': {'date': '2013-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'mean change of renal function (serum creatine, cystatin C, eGFR)', 'timeFrame': '24 weeks'}, {'measure': 'blood pressure', 'timeFrame': '24 weeks'}], 'primaryOutcomes': [{'measure': 'the percentage change of proteinuia', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'the proportion of patients achieving at least a 15% decrease in proteinuria', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['mild proteinuria', 'calcitriol', 'renal function', 'blood pressure'], 'conditions': ['Chronic Kidney Disease', 'Proteinuria']}, 'descriptionModule': {'briefSummary': 'The safety and efficacy of Caltriol on mild proteinuria (\\<1.0g/d) reduction in CKD patients.', 'detailedDescription': 'Proteinuria is not only a capital sign of kidney disease, but also a marker of chronic kidney disease (CKD) progression. Emerging evidence in patients with CKD show that vitamin D and its analogs can reduce proteinuria or albuminuria in the presence of angiotensin-converting enzyme inhibithion. While some of the studies reported that vitamin D receptor activation has been associated with increased serum creatinine and reduced estimated glomerular filtration rates. Therefore, the investigators plan to conduct a randomized clinical study to evaluate the efficacy and safety of Calcitriol in the treatment of mild proteinuria (\\<1.0g/d) CKD patients,which has no specific treatment at present.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18-75 years\n* clinical diagnosed and/or biopsy-confirmed primary glomerulonephritis\n* proteinuria 0.15-1.0 g/d in 2 consecutive samples within 4 weeks despite ACE inhibitor (ACEI) or angiotensin receptor blocker (ARB) treatment for at least 1 year or ACEI/ARB withdrawal because of of drug intolerances (low blood pressure, cough, hyperkalemia) for at least 1 month\n* estimated glomerular filtration rate (eGFR)\\>60ml/min/1/73m2\n* corticosteroid and immunosuppressive agents withdrawal for at least 6 months\n* normal blood pressure\n* serum intact parathyroid hormone (iPTH) level \\>20pg/mL\n* corrected serum calcium level \\< or = 2.55 mmol/L\n* serum phosphorus level \\< or = 1.68 mmol/L\n* 24 hours urinary calcium excretion level \\< or = 7.5 mmol\n* not receive treatment of vitamin D or its analogue within 6 months\n* willigness to give written consent and comply with the study protocol\n\nExclusion Criteria:\n\n* history of sensitivity or allergy to calcitriol or other vitamin D analogs\n* pregnancy, lactating women\n* history of severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension\n* history of malignancy\n* history of extraskeletal calcification, hyperuricemia, gout, kidney stone, gall stone, bone diseases\n* patients receiving drugs contains of calcium\n* patients receiving cimetidine, trimethoprim, or other drugs which can increase tubular creatinine reabsorption\n* participation in any other trials within 1 month\n* history of non-compliance'}, 'identificationModule': {'nctId': 'NCT01820832', 'briefTitle': 'Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD', 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': 'Phase 4 Study of Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD', 'orgStudyIdInfo': {'id': 'Calcitriol-MP-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Calcitriol', 'description': 'General treatments (such as blood pressure control, lipid lowering, and so on) plus Calcitriol 0.5 ug/BIW for 24 weeks.', 'interventionNames': ['Drug: Calcitriol']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'General treatments.'}], 'interventions': [{'name': 'Calcitriol', 'type': 'DRUG', 'otherNames': ['1, 25 - dihydroxy Cholecalciferol'], 'description': 'Calcitriol 0.5 ug/BIW for 24 weeks.', 'armGroupLabels': ['Calcitriol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Li You, M.D. PhD', 'role': 'CONTACT', 'email': 'youlizzy@gmail.com', 'phone': '86-21-52888133'}], 'facility': 'Huashan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jing Chen, M.D. PhD', 'role': 'CONTACT', 'email': 'chenjing1998@fudan.edu.cn', 'phone': '86-21-52889387'}, {'name': 'Li You, M.D. PhD', 'role': 'CONTACT', 'email': 'youlizzy@gmail.com', 'phone': '86-21-52888133'}], 'overallOfficials': [{'name': 'Jing Chen, M.D. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Nephrology, Huashan Hospital, Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, PhD., MD, Renal Division', 'investigatorFullName': 'Jing Chen', 'investigatorAffiliation': 'Huashan Hospital'}}}}