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Renal Function Among Thalassemia Patients Treated by a Oral Chelator Deferasirox

NCT ID: NCT01905774

Last Updated: 2015-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Thalassemia Iron Overload

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Deferasirox

Intervention Type DRUG

Interventions

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Deferasirox

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Dr Koren Ariel

Head of Pediatric Dpt B and Pediatric Hematology Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ariel Koren, MD

Role: PRINCIPAL_INVESTIGATOR

Ha'Emek Medical Center, Afula, Israel

Locations

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Ha'Emek Medical Center

Afula, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 18581145 (View on PubMed)

Other Identifiers

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0089-10-EMC

Identifier Type: -

Identifier Source: org_study_id

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