Renal Function Among Thalassemia Patients Treated by a Oral Chelator Deferasirox

Completed

• Conditions: Iron Overload; Thalassemia
• Interventions: Drug: Deferasirox

• Registration Number: NCT01905774
• Lead Sponsor: HaEmek Medical Center, Israel

Brief 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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-09-27
• Study First Submitted QC: 2013-07-18
• Study First Posted: 2013-07-23
• Primary Completion: 2014-12
• Status Verified: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-30
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Deferasirox	Deferasirox	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.

Primary Outcome Measures

Name	Time	Method
Renal function in Thalassemia patients treated by Deferasirox	One year study	Analysis of renal tubular function in patients treated by Deferasirox compared to patients treated by deferrioxamine

Trial Locations

Locations (1)

Ha'Emek Medical Center; 🇮🇱 Afula, Israel