Status:
TERMINATED
Efficacy, Safety Study and Benefit of Alkali Therapy in Sickle Cell Disease
Lead Sponsor:
University Hospitals Cleveland Medical Center
Conditions:
Sickle Cell Anemia
Chronic Kidney Disease
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
Primary Objective: To assess the effect of alkali administration on bicarbonate and potassium levels in patients with SCD and depressed serum bicarbonate levels. Secondary Objectives: To assess the...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01894594
Start Date
June 1 2013
End Date
March 1 2019
Last Update
March 20 2019
Active Locations (1)
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1
University hospitals Case Medical Center
Cleveland, Ohio, United States, 44106