Efficacy, Safety Study and Benefit of Alkali Therapy in Sickle Cell Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01894594|
Recruitment Status : Terminated (Poor recruitment)
First Posted : July 10, 2013
Last Update Posted : March 20, 2019
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Anemia Chronic Kidney Disease Metabolic Acidosis||Drug: Sodium Bicarbonate||Phase 1|
To assess the effect of alkali administration on bicarbonate and potassium levels in patients with SCD and depressed serum bicarbonate levels.
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.
To assess the influence of alkali administrations on markers of kidney tubule inflammation.
To 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Alkali Therapy in Subjects With Sickle Cell Disease (SCD) - Evaluation of Efficacy, Safety, and Beneficial Effects|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||March 2019|
|Actual Study Completion Date :||March 2019|
Experimental: Sodium Bicarbonate
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:
Drug: Sodium Bicarbonate
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.
0-4 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
* to the closest dose of 650 mg (7.74 mEq)
Ideal Body Weight is defined by the following formulas (Devine Calculation):
Ideal Body Weight (men) = 50 + 2.3 (Height (in) - 60) Ideal Body Weight (women) = 45.5 + 2.3 ( Height (in) - 60)
Other Name: Alkali Therapy
- Serum bicarbonate level [ Time Frame: 12 weeks ]To assess the effect of alkali administration on bicarbonate and potassium levels in patients with SCD and depressed serum bicarbonate levels.
- Hemolysis markers [ Time Frame: 12 weeks ]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.
- Tubular effect [ Time Frame: 12 weeks ]To assess the influence of alkali administrations on markers of kidney tubule inflammation.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 100 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Sickle cell disease patients with HbSS
- eGFR <90 ml/min/1.73m2 (determined by abbreviated 4 variable modification MDRD equation) and/or measured urinary albumin to creatinine ratio >30mg/g.
- Age ≥18 years
- Previous chronic treatment with alkali (including sodium bicarbonate, calcium carbonate or baking soda)
- Bicarbonate level >25 mEq/L
- Decompensated heart failure
- Uncontrolled systolic blood pressure >140 mm/Hg (the cutoff for systolic hypertension in SCD is lower than in non-SCD)
- Moderate-to-severe lower extremity edema
- Projected progression to ESRD within 6 months
- Kidney transplantation
- Treatment with immunosuppressives within the last 3 months
- Vasoocclusive (VOC) within 1 week of study entry
- Active (open) leg ulcer
- Change in hydroxyurea dose within the last 3 months, unless a self-limited interruption of a stable dose
- Blood transfusion within 8 weeks, unless on chronic transfusions
- Inability to give informed consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894594
|United States, Ohio|
|University hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Jane Little, MD||University Hospitals Cleveland Medical Center|
|Responsible Party:||Jane Little, Director, Sickle Cell Disease Program, University Hospitals Cleveland Medical Center|
|Other Study ID Numbers:||
|First Posted:||July 10, 2013 Key Record Dates|
|Last Update Posted:||March 20, 2019|
|Last Verified:||February 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Sickle cell disease
Chronic kidney disease
Renal Insufficiency, Chronic
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn