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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01905774
Other study ID # 0089-10-EMC
Secondary ID
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


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
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