Clinical Trial Details
| Trial ID: | L1377 |
| Source ID: | NCT01894594 |
| Associated Drug: | Sodium Bicarbonate |
| Title: | Efficacy, Safety Study and Benefit of Alkali Therapy in Sickle Cell Disease |
| Acronym: | |
| Status: | TERMINATED |
| Study Results: | NO |
| Results: | |
| Conditions: | Sickle Cell Anemia|Chronic Kidney Disease|Metabolic Acidosis |
| Interventions: | DRUG: Sodium Bicarbonate |
| Outcome Measures: | Primary: Serum bicarbonate level, To assess the effect of alkali administration on bicarbonate and potassium levels in patients with SCD and depressed serum bicarbonate levels., 12 weeks | Secondary: Hemolysis markers, 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., 12 weeks | Other: Tubular effect, To assess the influence of alkali administrations on markers of kidney tubule inflammation., 12 weeks |
| Sponsor/Collaborators: | Sponsor: University Hospitals Cleveland Medical Center |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 7 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2013-06 |
| Completion Date: | 2019-03 |
| Results First Posted: | |
| Last Update Posted: | 2019-03-20 |
| Locations: | University hospitals Case Medical Center, Cleveland, Ohio, 44106, United States |
| URL: | https://clinicaltrials.gov/show/NCT01894594 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
|---|