Efficacy, Safety Study and Benefit of Alkali Therapy in Sickle Cell Disease
| Status: | Terminated |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Anemia |
| Therapuetic Areas: | Hematology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 3/22/2019 |
| Start Date: | June 2013 |
| End Date: | March 2019 |
Alkali Therapy in Subjects With Sickle Cell Disease (SCD) - Evaluation of Efficacy, Safety, and Beneficial Effects
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.
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.
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 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.
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 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.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
1
site
Cleveland, Ohio 44194
Principal Investigator: Jane Little, MD
Phone: 216-844-5868
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