Renal Function Among Thalassemia Patients Treated by a Oral Chelator Deferasirox

NCT01905774 | Completed

• 1 other identifier: 0089-10-EMC
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Thalassemia; Iron Overload

Keywords

Renal Function

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Deferasirox DRUG

Deferasirox

Eligibility Criteria

• Age: 1 Year - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with Thalassemia Major or Intermedia treated by Iron chelators or by blood transfusions without treatment with iron chelators

You may qualify if:

• Patients with Thalassemia Major or Intermedia treated by Iron chelators or by blood transfusions without treatment with iron chelators

You may not qualify if:

• None relevant

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Ha'Emek Medical Center

Afula, 18101, Israel

Location

Related 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.

  PMID: 18581145 BACKGROUND

MeSH Terms

Conditions

Thalassemia; Iron Overload

Interventions

Deferasirox

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ariel Koren, MD

  Ha'Emek Medical Center, Afula, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pediatric Dpt B and Pediatric Hematology Unit

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: July 23, 2013
• Study Start: March 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: August 1, 2015
• Last Updated: September 1, 2015

Record last verified: 2015-08

Locations

IL (1)