Renal Function Among Thalassemia Patients Treated by a Oral Chelator Deferasirox

• Sponsor: HaEmek Medical Center, Israel (Other)
• Overall Status: Completed
• CT.gov ID: NCT01905774
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Duration (Months): 53
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thalassemia; Iron Overload	Drug: Deferasirox

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 Design

• Study Type: Observational
• Actual Enrollment: 36 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Renal Function Among Thalassemia Patients Treated by a Oral Chelator Deferasirox
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Deferasirox

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ha'Emek Medical Center	Afula		Israel	18101

Sponsors and Collaborators

• HaEmek Medical Center, Israel

Investigators

• Principal Investigator: Ariel Koren, MD, Ha'Emek Medical Center, Afula, Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Dr Koren Ariel, Head of Pediatric Dpt B and Pediatric Hematology Unit, HaEmek Medical Center, Israel
• ClinicalTrials.gov Identifier: NCT01905774
• Other Study ID Numbers: 0089-10-EMC
• First Posted: Jul 23, 2013
• Last Update Posted: Sep 1, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Dr Koren Ariel, Head of Pediatric Dpt B and Pediatric Hematology Unit, HaEmek Medical Center, Israel: Renal Function
• Additional relevant MeSH terms: Thalassemia; Iron Overload; Deferasirox

Study Results

No Results Posted as of Sep 1, 2015