Renal Function Among Thalassemia Patients Treated by a Oral Chelator Deferasirox

HaEmek Medical Center, Israel

Status: Completed

Conditions: Thalassemia; Iron Overload

Treatments: Drug: Deferasirox

Study type: Observational

Funder types: Other

Identifiers

NCT01905774

0089-10-EMC

Details and patient eligibility

About

Thalassemia Major patients developed Iron Overload due to blood transfusions and intestinal iron absorption. Renal function caused by Iron overload was studied in a previous study and shows principally tubular disfunction. In this previous study the Iron chelator used was Deferrioxamine. In the last five years an oral Iron chelator was introduced and approved by the FDA, Deferasirox, (Novartis, Switzerland and USA). The purpose of this study is to assess the renal function in Thalassemia Major patients treated with this new oral iron chelator and compare the results with our previous study.

Full description

Patients with Thalassemia Major. The laboratory tests that will be studied are: Urine dip stick, Urea, Creatinine, Na, K, Uric Acid, Calcium, Phosphorus in serum and urine, and N acetyl-b-D-glucosaminidase in Urine.Blood gases will be also taken in serum samples.

The overall iron accumulation will also be calculated based in the amount of Packed Cells Units transfused. The total iron burden will also assessed by measurement of Transferrin saturation and Serum Ferritin.

Enrollment: 36 patients

Sex: All

Ages: 1 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Thalassemia Major or Intermedia treated by Iron chelators or by blood transfusions without treatment with iron chelators

Exclusion criteria

None relevant

Trial design

36 participants in 1 patient group

Deferasirox

Description:

The patients will be treated by the primary physician according to clinical status. The Deferasirox dose range is between 20 to 40 mg/kg/day once daily dose. The treatment is a continuous treatment and not a single course.

Treatment:

Drug: Deferasirox