Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 8:56 AM
Study NCT ID:
NCT01894594
Status:
TERMINATED
Last Update Posted:
2019-03-20
First Post:
2013-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy, Safety Study and Benefit of Alkali Therapy in Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D000138', 'term': 'Acidosis'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017693', 'term': 'Sodium Bicarbonate'}], 'ancestors': [{'id': 'D001639', 'term': 'Bicarbonates'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Poor recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-18', 'studyFirstSubmitDate': '2013-07-03', 'studyFirstSubmitQcDate': '2013-07-09', 'lastUpdatePostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Tubular effect', 'timeFrame': '12 weeks', 'description': 'To assess the influence of alkali administrations on markers of kidney tubule inflammation.'}], 'primaryOutcomes': [{'measure': 'Serum bicarbonate level', 'timeFrame': '12 weeks', 'description': 'To assess the effect of alkali administration on bicarbonate and potassium levels in patients with SCD and depressed serum bicarbonate levels.'}], 'secondaryOutcomes': [{'measure': 'Hemolysis markers', 'timeFrame': '12 weeks', 'description': 'To assess the effect of alkali administration on improvement in hemolysis and on sequelae of impaired kidney function, ie, LDH, Hgb, reticulocyte count, red cell half-life, and muscle strength, Vitamin D levels, and markers of bone turnover, respectively.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sickle cell disease', 'Chronic kidney disease', 'Bicarbonate therapy'], 'conditions': ['Sickle Cell Anemia', 'Chronic Kidney Disease', 'Metabolic Acidosis']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the effect of alkali administration on bicarbonate and potassium levels in patients with Sickle Cell Disease (SCD) and depressed serum bicarbonate levels. The study is a prospective non-blinded evaluation of tolerability and efficacy of alkali repletion with 4 weeks of observation and two sequential 4 week courses of escalating oral sodium bicarbonate treatment.', 'detailedDescription': 'Primary Objective:\n\nTo assess the effect of alkali administration on bicarbonate and potassium levels in patients with SCD and depressed serum bicarbonate levels.\n\nSecondary Objectives:\n\nTo assess the effect of alkali administration on improvement in hemolysis and on sequelae of impaired kidney function, ie, LDH, Hgb, reticulocyte count, red cell half-life, and muscle strength, Vitamin D levels, and markers of bone turnover, respectively.\n\nTo assess the influence of alkali administrations on markers of kidney tubule inflammation.\n\nTo evaluate intraparenchymal iron in patients with SCD and renal dysfunction. Safety and adverse events of alkali patients with sickle cell disease will be monitored. This research will supplement current knowledge about management of the clinically important subset of people with SCD who have renal insufficiency and acid-base perturbation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sickle cell disease patients with HbSS\n* eGFR \\<90 ml/min/1.73m2 (determined by abbreviated 4 variable modification MDRD equation) and/or measured urinary albumin to creatinine ratio \\>30mg/g.\n* Age ≥18 years\n\nExclusion Criteria:\n\n* Previous chronic treatment with alkali (including sodium bicarbonate, calcium carbonate or baking soda)\n* Bicarbonate level \\>25 mEq/L\n* Decompensated heart failure\n* Uncontrolled systolic blood pressure \\>140 mm/Hg (the cutoff for systolic hypertension in SCD is lower than in non-SCD)\n* Moderate-to-severe lower extremity edema\n* Projected progression to ESRD within 6 months\n* Kidney transplantation\n* Treatment with immunosuppressives within the last 3 months\n* Vasoocclusive (VOC) within 1 week of study entry\n* Active (open) leg ulcer\n* Change in hydroxyurea dose within the last 3 months, unless a self-limited interruption of a stable dose\n* Blood transfusion within 8 weeks, unless on chronic transfusions\n* Pregnancy\n* Inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT01894594', 'briefTitle': 'Efficacy, Safety Study and Benefit of Alkali Therapy in Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Alkali Therapy in Subjects With Sickle Cell Disease (SCD) - Evaluation of Efficacy, Safety, and Beneficial Effects', 'orgStudyIdInfo': {'id': '09-12-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sodium Bicarbonate', 'description': 'Patients will be monitored at baseline bi-weekly intervals for 12 weeks, the first 4 weeks to establish a stable baseline, followed by 8 weeks of alkali therapy, as follows:', 'interventionNames': ['Drug: Sodium Bicarbonate']}], 'interventions': [{'name': 'Sodium Bicarbonate', 'type': 'DRUG', 'otherNames': ['Alkali Therapy'], 'description': 'Oral sodium bicarbonate tablets administered at a starting dose of 0.6 mEQ/Kg body weight and will be escalated once, at 4 weeks, to 0.9 mEQ/Kg body weight.\n\nWeekly schedule:\n\n0-4 weeks: Serial Measurement at baseline, without therapy 4-8 weeks: \\*\\~0.6 mEq/kg of ideal body weight of Sodium Bicarbonate tablets divided into TID dosing 8-12 weeks: \\*\\~0.9 mEq/kg of ideal body weight of Sodium Bicarbonate tablets divided into TID dosing\n\n\\* to the closest dose of 650 mg (7.74 mEq)\n\nIdeal Body Weight is defined by the following formulas (Devine Calculation):\n\nIdeal Body Weight (men) = 50 + 2.3 (Height (in) - 60) Ideal Body Weight (women) = 45.5 + 2.3 ( Height (in) - 60)', 'armGroupLabels': ['Sodium Bicarbonate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University hospitals Case Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Jane Little, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Sickle Cell Disease Program', 'investigatorFullName': 'Jane Little', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}