Renal Function Among Thalassemia Patients Treated by a Oral Chelator Deferasirox

Thalassemia Clinical Trial

Official title:

Renal Function Among Thalassemia Patients Treated by a Oral Chelator Deferasirox

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01905774
• Other study ID #: 0089-10-EMC
• Status: Completed
• Phase: N/A
• First received: September 27, 2011
• Last updated: August 30, 2015
• Start date: March 2011
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 45 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Iron Overload
• Thalassemia

Intervention

Drug:
• Deferasirox

Locations

Country	Name	City	State
Israel	Ha'Emek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Smolkin V, Halevy R, Levin C, Mines M, Sakran W, Ilia K, Koren A. Renal function in children with beta-thalassemia major and thalassemia intermedia. Pediatr Nephrol. 2008 Oct;23(10):1847-51. doi: 10.1007/s00467-008-0897-8. Epub 2008 Jun 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function in Thalassemia patients treated by Deferasirox	Analysis of renal tubular function in patients treated by Deferasirox compared to patients treated by deferrioxamine	One year study	No