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Renal Function Among Thalassemia Patients Treated by a Oral Chelator Deferasirox

Renal Function Among Thalassemia Patients Treated by a Oral Chelator Deferasirox

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01905774
Enrollment
36
Registered
2013-07-23
Start date
2011-03-31
Completion date
2015-08-31
Last updated
2015-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Overload, Thalassemia

Keywords

Renal Function

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.

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.

Interventions

DRUGDeferasirox

Sponsors

HaEmek Medical Center, Israel
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Renal function in Thalassemia patients treated by DeferasiroxOne year studyAnalysis of renal tubular function in patients treated by Deferasirox compared to patients treated by deferrioxamine

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026