Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)
Launched by PHARMACOSMOS A/S · Oct 19, 2016
Trial Information
Current as of July 04, 2025
Completed
Keywords
ClinConnect Summary
IDA is highly prevalent condition in subjects with cancer and gastrointestinal diseases such as inflammatory bowel diseases, menstruating or pregnant women, and subjects who have undergone bariatric procedure or surgery. IDA can have a substantial medical and quality of life (QoL) burden. Treatment of subjects diagnosed with IDA includes controlling the bleeding and replenishing lost iron.
This study was designed to evaluate the safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose in subjects diagnosed with IDA. In a subfraction of 35 subjects treated wi...
Gender
ALL
Eligibility criteria
- Inclusion criteria includes:
- • 1. Men or women ≥ 18 years
- • 2. Subjects having IDA caused by different etiologies
- 3. Subjects with intolerance to oral iron therapy or a need for rapid repletion of iron stores:
- • 4. Haemoglobin (Hb) ≤ 11 g/dL
- • 5. Transferrin Saturation (TSAT) \< 20 %
- • 6. S-ferritin \< 100 ng/mL
- • 7. Willingness to participate and signing the informed consent form
- Exclusion Criteria includes :
- • 1. Anemia predominantly caused by factors other than IDA
- • 2. Hemochromatosis or other iron storage disorders
- • 3. Previous serious hypersensitivity reactions to any IV iron compound
- • 4. Erythropoiesis stimulating agent (ESA) treatment
- • 5. Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
- • 6. Will require a surgical procedure that necessitated general anesthesia prior to screening or during the trial period
- • 7. Alanine aminotransferase and/or aspartate aminotransferase \> 3 times upper limit of normal
- • 8. Required dialysis for treatment of chronic kidney disease (CKD)
- • 9. Alcohol or drug abuse within the past 6 months
- • 10. Pregnant or nursing women
About Pharmacosmos A/S
Pharmacoms A/S is a specialized biopharmaceutical company dedicated to advancing innovative therapies for the treatment of rare and complex diseases. With a strong focus on developing high-quality, clinically validated products, Pharmacoms leverages cutting-edge research and development to address unmet medical needs. The company is committed to ensuring patient safety and efficacy through rigorous clinical trials and regulatory compliance, while fostering strategic partnerships within the healthcare community to enhance therapeutic outcomes and improve patient quality of life.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Brooklyn, New York, United States
Little Rock, Arkansas, United States
Rialto, California, United States
Riverside, California, United States
Plainville, Connecticut, United States
Boynton Beach, Florida, United States
Doral, Florida, United States
Fort Lauderdale, Florida, United States
Hollywood, Florida, United States
Lake City, Florida, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
Palmetto Bay, Florida, United States
Plantation, Florida, United States
Wichita, Kansas, United States
Owensboro, Kentucky, United States
Baton Rouge, Louisiana, United States
Shreveport, Louisiana, United States
Bethesda, Maryland, United States
Grand Rapids, Michigan, United States
Florissant, Missouri, United States
New York, New York, United States
Jacksonville, North Carolina, United States
Wilmington, North Carolina, United States
Cincinnati, Ohio, United States
Norman, Oklahoma, United States
Tulsa, Oklahoma, United States
Columbia, South Carolina, United States
Austin, Texas, United States
Beaumont, Texas, United States
Desoto, Texas, United States
Houston, Texas, United States
Birmingham, Alabama, United States
Dothan, Alabama, United States
Guntersville, Alabama, United States
Phoenix, Arizona, United States
Foothill Ranch, California, United States
La Mesa, California, United States
La Mesa, California, United States
Long Beach, California, United States
National City, California, United States
Northridge, California, United States
Northridge, California, United States
Oceanside, California, United States
Quartz Hill, California, United States
San Diego, California, United States
San Marcos, California, United States
Whittier, California, United States
Aventura, Florida, United States
Doral, Florida, United States
Doral, Florida, United States
Hialeah, Florida, United States
Kissimmee, Florida, United States
Lake Worth, Florida, United States
Miami Lakes, Florida, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Naples, Florida, United States
West Palm Beach, Florida, United States
Champaign, Illinois, United States
Joliet, Illinois, United States
Palos Heights, Illinois, United States
Terre Haute, Indiana, United States
Marrero, Louisiana, United States
Metairie, Louisiana, United States
New Orleans, Louisiana, United States
Hagerstown, Maryland, United States
Towson, Maryland, United States
Fall River, Massachusetts, United States
Saginaw, Michigan, United States
Troy, Michigan, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Neptune, New Jersey, United States
Plainsboro, New Jersey, United States
East Setauket, New York, United States
East Setauket, New York, United States
Beavercreek, Ohio, United States
Canton, Ohio, United States
Centerville, Ohio, United States
Columbus, Ohio, United States
Jenkintown, Pennsylvania, United States
Myrtle Beach, South Carolina, United States
Chattanooga, Tennessee, United States
Franklin, Tennessee, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Baytown, Texas, United States
Corsicana, Texas, United States
Mcallen, Texas, United States
San Antonio, Texas, United States
Ogden, Utah, United States
Chesapeake, Virginia, United States
Tacoma, Washington, United States
Patients applied
Trial Officials
Pharmacosmos A/S Clinical and Non-clinical Research
Study Director
Pharmacosmos A/S
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials