NCT01905774

Renal Function Among Thalassemia Patients Treated by a Oral Chelator Deferasirox

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: HaEmek Medical Center, Israel · Academic / Other
• Sex: All
• Age: 1 Year – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Thalassemia
• Iron Overload

Interventions

Type	Name	Description
DRUG	Deferasirox

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-12-01
• Completion: 2015-08-01
• First posted: 2013-07-23
• Last updated: 2015-09-01

Locations

1 site across 1 country: Israel