Use of Hydroxyurea and Magnesium Pidolate for Treatment of Sickle Cell Disease

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to estimate the MTD of Mg pidolate in combination with HU in patients with sickle cell disease who have been on a therapeutic dose (15-30 mg/kg/day) of HU for at least 6 months.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Treatments: Hydroxyurea

Criteria

Inclusion Criteria:

1. Age > 3 years and < 15 years at the time of study enrollment

2. Diagnosis of Hb SS or Hb S beta thalassemia

3. Hydroxyurea treatment for at least 6 months prior to study entry at dose of 15 - 30 mg/kg/day

4. Compliance with taking HU treatment of at least 70 % for 6 months prior to study entry

Exclusion Criteria:

1. Red blood cell transfusion within the last 3 months resulting in a level of Hb A of 10% or more

2. Pregnancy or unwillingness to use effective birth control in sexually active subjects (females who state that they are sexually active)

3. Renal dysfunction defined by a serum creatinine greater than 1.5 times the upper limit of normal for age

4. Liver dysfunction defined by an ALT greater than twice the upper limit of normal for age

5. Concomitant usage of an "antisickling" agent other than hydroxyurea

6. Current use of Mg containing drugs

7. Iron deficiency, defined by serum ferritin ≤ 10 ng/ml

8. Concomitant chronic illness other than sickle cell anemia