Combination Iron Chelation Therapy

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00004982
First received: March 13, 2000
Last updated: January 12, 2010
Last verified: January 2010
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment

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

ClinicalTrials.gov Identifier: NCT00004982     History of Changes
Obsolete Identifiers: NCT00004536
Other Study ID Numbers: CHELATION (completed), 1R01DK55463-01
Study First Received: March 13, 2000
Last Updated: January 12, 2010
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:
Thalassemia
Iron Overload
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014