Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-03-08 @ 4:27 AM
Study NCT ID:
NCT02410005
Status:
TERMINATED
Last Update Posted:
2017-06-15
First Post:
2015-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention Using Vitamin D for Elevated Urinary Albumin Treated With Losartan in Diabetes (IDEAL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}], 'ancestors': [{'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': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002117', 'term': 'Calcitriol'}, {'id': 'D019808', 'term': 'Losartan'}], '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'}, {'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'whyStopped': 'Logistic challenges', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2015-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-13', 'studyFirstSubmitDate': '2015-02-18', 'studyFirstSubmitQcDate': '2015-04-01', 'lastUpdatePostDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Urine mRNA/miRNA expression', 'timeFrame': '15 months'}, {'measure': 'Urine Albumin-to-Creatinine Ratio (UACR)', 'timeFrame': '15 months'}, {'measure': 'Blood Pressure (BP)', 'timeFrame': '15 months'}, {'measure': 'Estimated glomuerula filtration rate (eGFR)', 'timeFrame': '15 months'}], 'primaryOutcomes': [{'measure': '24h urine 24hr urine albuminuria', 'timeFrame': '12 month', 'description': '24h urine albuminuria (log transformed) from baseline to 12 months post-randomization in the losartan plus calcitriol group compared to the losartan alone group.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Nephropathies']}, 'descriptionModule': {'briefSummary': 'This study is a single center open-label randomized controlled trial designed to evaluate the efficacy of calcitriol plus losartan therapy in subjects with type II diabetes and macroalbuminuria.', 'detailedDescription': 'The investigators propose to test the efficacy and safety of a combined regimen of calcitriol and losartan in subjects with type II diabetes (T2DM) with macroalbuminuria. Should the investigators study confirm the hypothesis that the proposed novel regimen is superior to the current practice of renin-angiotensin-aldosterone system blockade, the study would significantly advance the care of subjects with type II diabetes and kidney disease in Qatar and worldwide. In this regard it is worth noting that the prevalence of end stage renal disease in Qatar is 202 subjects per million population. This would translate into fewer subjects requiring dialysis or transplantation, an enormous benefit to individuals and society.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of T2DM requiring treatment with at least one oral hypoglycemic medication or insulin\n2. Macroalbuminuria as defined as the presence of a UACR greater than 300 mg/gm creatinine (30 mg/mmol creatinine) on two occasions in the last six months\n3. Estimated eGFR of 30 to 90 mL/min/1.73 m2\n\nExclusion Criteria:\n\n1. Positive Pregnancy Test or planning pregnancy in the subsequent 18months (if female)\n2. Serum Calcium \\> 2.45 mmol/L (9.8 mg/dL)\n3. Serum Phosphorus \\> 1.78 mmol/L (5.5 mg/dL)\n4. Serum Potassium \\> 5.5 mmol/L (5 mEq/L)\n5. Parathyroid hormone \\< 20 pg/mL or \\> 500 pg/mL\n6. Hemoglobin A1C \\> 12%\n7. 25-OH Vit D \\> 50 ng/mL\n8. Poorly controlled hypertension defined as systolic blood pressure \\>= 180 mm Hg or diastolic blood pressure \\>= 110 mm Hg\n9. History of kidney stones\n10. History of severe disease like chronic liver disease\n11. Active malignancy\n12. Active granulomatous diseases like turburculosis and sarcoidosis\n13. Recent diagnosis of acute renal failure within 3 months of screening visit\n14. Likelihood of renal replacement therapy within 1 year\n15. History of parathyroidectomy\n16. Currently taking calcitriol or 1,25-dihydroxyvitamin D analog\n17. Currently taking calcitonin, bisphosphonates, cinacalcet, teriparatide, glucocorticoids or other drugs that may affect calcium or bone metabolism (subjects may be taking calcium containing phosphate binder or other phosphate binder. Subjects may also be taking stable dose of estrogen/progestin)\n18. History of osteoporosis or other bone disorder requiring calcitriol therapy\n19. History of allergic reaction to calcitriol, paracalcitol, hectoral, or other 1,25-dihydroxyvitamin D analogs\n20. History of allergic reaction to losartan or any other angiotensin receptor blocker therapy\n21. Evidence of drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT02410005', 'acronym': 'IDEAL', 'briefTitle': 'Intervention Using Vitamin D for Elevated Urinary Albumin Treated With Losartan in Diabetes (IDEAL)', 'organization': {'class': 'OTHER', 'fullName': 'Weill Cornell Medical College in Qatar'}, 'officialTitle': 'Kidney Disease in Type 2 Diabetes Mellitus: Biomarker Discovery and Novel Therapeutics', 'orgStudyIdInfo': {'id': '14-00039'}, 'secondaryIdInfos': [{'id': 'NPRP No: 4-1392-3-345', 'type': 'OTHER_GRANT', 'domain': 'Qatar National Research Fund'}, {'id': '14-00039', 'type': 'OTHER', 'domain': 'HMC/WCMC-Q JIRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Losartan alone', 'description': 'In the losartan alone group, subjects are prescribed: losartan 50mg twice daily.', 'interventionNames': ['Drug: Losartan']}, {'type': 'EXPERIMENTAL', 'label': 'Losartan and Calcitriol', 'description': 'In the losartan plus calcitriol group, subjects are prescribed: losartan 50mg twice daily and calcitriol 0.25mcg daily.', 'interventionNames': ['Dietary Supplement: Calcitriol', 'Drug: Losartan']}], 'interventions': [{'name': 'Calcitriol', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['1,25-dihydroxycholecalciferol', '1,25-dihydroxyvitamin D3'], 'armGroupLabels': ['Losartan and Calcitriol']}, {'name': 'Losartan', 'type': 'DRUG', 'armGroupLabels': ['Losartan alone', 'Losartan and Calcitriol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '24144', 'city': 'Doha', 'country': 'Qatar', 'facility': 'Weill Cornell Medical College in Qatar', 'geoPoint': {'lat': 25.28545, 'lon': 51.53096}}, {'city': 'Doha', 'country': 'Qatar', 'facility': 'Hamad Medical Corporation', 'geoPoint': {'lat': 25.28545, 'lon': 51.53096}}], 'overallOfficials': [{'name': 'Phyllis August, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Cornell Medical College in Qatar', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hamad Medical Corporation', 'class': 'INDUSTRY'}, {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}