Efficacy, Safety Study and Benefit of Alkali Therapy in Sickle Cell Disease
Stopped early · Phase 1
Conditions studied: Sickle Cell Anemia, Chronic Kidney Disease, Metabolic Acidosis
In brief
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.
Key facts
- Study ID
- NCT01894594
- Run by
- University Hospitals Cleveland Medical Center
- People needed
- 7
- Starts
- 2013-06-01
- Expected to finish
- 2019-03-01
- Last updated by the study team
- 2019-03-20
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Pregnancy
- Inability to give informed consent
Where it is running
- University hospitals Case Medical Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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