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Combination Iron Chelation Therapy
This study has been completed.
First Received: March 13, 2000   Last Updated: June 23, 2005   History of Changes
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00004982
  Purpose

Patients with beta-thalassemia (Cooley's Anemia) continue to suffer from the transfusion-induced iron overload due to the inadequacies of current iron-chelation therapy. Compliance with the use of the only FDA-approved drug for removing excess iron from patients (Desferal) continues to be a major problem despite convincing evidence that it markedly reduces morbidity and prolongs life. The full potential of iron-chelation therapy will not be realized until an orally-effective drug is available. This small trial is testing the premise that a combination of drugs as a new approach to iron chelation therapy may reduce side effects and increase efficacy. If both drugs can be given orally, there may be a better chance of finding a suitable alternative to Desferal. Several combinations of experimental iron chelating drugs are being used in this trial.


Condition Intervention Phase
Iron Overload
Thalassemia
Drug: Combination Iron Chelation Therapy
Phase I

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Study Start Date: December 1998
Estimated Study Completion Date: November 2002
  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Iron overload

Exclusion Criteria:

  • Overt cardiac disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004982

Locations
United States, New York
Cornell University Medical College
New York, New York, United States, 10021
Sponsors and Collaborators
  More Information

No publications provided

Study ID Numbers: CHELATION, 1R01DK55463-01
Study First Received: March 13, 2000
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00004982     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
chelation therapy
combination chemotherapy
iron poisoning
thalassemia
chelating agent
deferoxamine
drug screening /evaluation
therapy evaluation

Additional relevant MeSH terms:
Anemia, Hemolytic, Congenital
Metabolic Diseases
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies
Anemia
Anemia, Hemolytic
Iron Metabolism Disorders
Iron Overload
Thalassemia

ClinicalTrials.gov processed this record on November 27, 2009