Chronic Kidney Disease Clinical Trial
Official title:
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.
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.
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