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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR INJECTAFER

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Clinical Trials for Injectafer

Trial ID Title Status Sponsor Phase Summary
NCT00994318 Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) Completed ICON Clinical Research Phase 3 Phase IIIb study to evaluate the long-term efficacy of ferric carboxymaltose (FCM) (using targeted ferritin levels to determine dosing) or oral iron in non-dialysis-dependent chronic kidney disease (NDD-CKD) subjects with iron deficiency anaemia (IDA).
NCT00994318 Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) Completed Luitpold Pharmaceuticals Phase 3 Phase IIIb study to evaluate the long-term efficacy of ferric carboxymaltose (FCM) (using targeted ferritin levels to determine dosing) or oral iron in non-dialysis-dependent chronic kidney disease (NDD-CKD) subjects with iron deficiency anaemia (IDA).
NCT00994318 Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) Completed Vifor Inc. Phase 3 Phase IIIb study to evaluate the long-term efficacy of ferric carboxymaltose (FCM) (using targeted ferritin levels to determine dosing) or oral iron in non-dialysis-dependent chronic kidney disease (NDD-CKD) subjects with iron deficiency anaemia (IDA).
NCT01950247 Trial to Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron and to Compare Safety, Effect on Quality of Life, and Resource Utilization of Injectafer vs Intravenous Standard of Care for the Treatment of IDA in an Infu Active, not recruiting Luitpold Pharmaceuticals Phase 4 The main objective of this study is to compare the safety, effect on quality of life, and resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also assess the ability of baseline serum hepcidin levels to predict if subjects will have a clinically meaningful hemoglobin response to oral iron therapy or to IV iron therapy.
NCT02086968 Treatment Response of Injectafer vs. Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass Active, not recruiting Luitpold Pharmaceuticals Phase 4 The primary objective of this study is to evaluate the treatment response of Injectafer vs. oral iron to baseline hepcidin levels to determine if any of these select IBD or Gastric Bypass patients may demonstrate to be inappropriate for oral iron therapy.
NCT02397057 Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS Active, not recruiting Luitpold Pharmaceuticals Phase 3 This will be a Phase III, double blinded, multi-center, randomized, placebo-controlled study. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed for efficacy and safety for 12 months. The subject's participation in the study will be for approximately 1 year from Day 0.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Injectafer

Condition Name

Condition Name for Injectafer
Intervention Trials
Iron Deficiency 2
IDA - Iron Deficiency Anemia 2
Iron-deficiency 2
Heart Failure 2
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Condition MeSH

Condition MeSH for Injectafer
Intervention Trials
Anemia, Iron-Deficiency 12
Anemia 9
Deficiency Diseases 8
Heart Failure 3
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Clinical Trial Locations for Injectafer

Trials by Country

Trials by Country for Injectafer
Location Trials
United States 44
Poland 3
Portugal 1
Netherlands 1
Germany 1
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Trials by US State

Trials by US State for Injectafer
Location Trials
Texas 5
Florida 4
South Carolina 3
California 3
North Carolina 3
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Clinical Trial Progress for Injectafer

Clinical Trial Phase

Clinical Trial Phase for Injectafer
Clinical Trial Phase Trials
Phase 4 3
Phase 3 7
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Injectafer
Clinical Trial Phase Trials
Not yet recruiting 5
Recruiting 5
Active, not recruiting 3
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Clinical Trial Sponsors for Injectafer

Sponsor Name

Sponsor Name for Injectafer
Sponsor Trials
Luitpold Pharmaceuticals 10
Vifor Inc. 2
Pharmacosmos A/S 2
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Sponsor Type

Sponsor Type for Injectafer
Sponsor Trials
Industry 16
Other 5
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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Baxter
Farmers Insurance
Cipla
Dow
Johnson and Johnson
Moodys
UBS
McKesson

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