50 completed, 7 terminated, 6 withdrawn. 27 Phase 3, 17 Phase 2, 10 Phase 4, 4 Phase 1, 2 Not applicable.
Follow American Regent, Inc.: new trials by email
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| IRONICA: IRON Repletion In Heart Failure - A Comparison of Oral and IV Approaches Ferric Carboxymaltose, Ferrous Sulfate - Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF) | Phase 4 | Terminated | Syed Hamza Mufarrih | 42 | 2025-04-02 | 2026-07-20 |
| Tralement Versus a Fixed-dose Trace Element Combination Product to Evaluate Manganese Safety Tralement, Fixed-dose trace element combination product of zinc, copper, and selenious acid - Manganese Safety in Adults | Phase 4 | Withdrawn | American Regent, Inc. | 2025-02-01 | 2025-02-12 | |
| Tralement vs. Fixed-dose Trace Element Combination Product in Patients >3 to 17 Years of Age Requiring Long-term PN Tralement, Fixed-dose trace element combination product of zinc, copper, and selenious acid - Manganese Safety in Pediatric Patients | Phase 4 | Withdrawn | American Regent, Inc. | 2024-08-01 | 2024-11-15 | |
| Effects of IV Iron Replacement on Exercise Capacity in Individuals With Heart Failure IV Iron Infusion Group - Heart Failure, Iron-deficiency | Phase 4 | Terminated | Radha Gopalan | 6 | 2024-01-24 | 2026-07-29 |
| Safety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With Iron Deficiency Anemia Ferric carboxymaltose - Iron Deficiency, Anaemia | Phase 2 | Withdrawn | American Regent, Inc. | 2022-07-21 | 2023-01-06 | |
| Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia and Unsatisfactory Response Oral Iron Under Study Protocol 1VIT17044 Ferric carboxymaltose - Iron Deficiency Anemia | Phase 3 | Completed | American Regent, Inc. | 7 | 2019-11-19 | 2022-03-21 |
| Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA Ferric carboxymaltose, Ferrous Sulfate - Iron Deficiency Anemia | Phase 3 | Completed | American Regent, Inc. | 79 | 2019-01-31 | 2022-06-22 |
| Efficacy of Ferric Carboxymaltose in Gastrointestinal Stromal Tumor (GIST) Patients With Iron Deficiency Anemia (IDA) Receiving Systemic Therapy Ferric Carboxymaltose, Iron Supplements, Questionnaire - Malignant Neoplasms of Mesothelial and Soft Tissue, Gastrointestinal Stromal Tumor With Neurogenic Differentiation | Phase 2 | Terminated | M.D. Anderson Cancer Center | 3 | 2017-12-18 | 2020-04-06 |
| Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia Injectafer® (Ferric Carboxymaltose - FCM), Placebo (Normal Saline) - Restless Legs Syndrome (RLS) | Phase 2 | Terminated | American Regent, Inc. | 70 | 2017-07-10 | 2025-04-11 |
| Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study Ferric Carboxymaltose, Placebo - Heart Failure, Iron-deficiency | Phase 3 | Completed | American Regent, Inc. | 3065 | 2017-03-15 | 2024-07-03 |
| Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer® Injectafer, Normal Saline - Cancer and Chemotherapy Related Anemia | Phase 3 | Completed | American Regent, Inc. | 244 | 2015-05-23 | 2021-05-11 |
| Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia Injectafer, Placebo - Iron Deficiency, Fibromyalgia | Phase 2 | Completed | American Regent, Inc. | 81 | 2015-03-01 | 2018-02-20 |
| A Study to Characterize the PK and PD Profile of IV FCM in Pediatric Subjects 1-17 Years Old With IDA Ferric Carboxymaltose (FCM) - Iron Deficiency Anemia (IDA) | Phase 2 | Completed | American Regent, Inc. | 35 | 2015-02-19 | 2022-07-25 |
| Double-blind Trial of Sodium Thiosulfate for the Treatment of Pain Associated With Calcific Uremic Arteriolopathy Sodium thiosulfate, Placebo - Calciphylaxis, Calcific Uremic Arteriolopathy | Phase 3 | Withdrawn | American Regent, Inc. | 2015-01-30 | 2025-05-07 | |
| Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS Injectafer, Placebo - Restless Legs Syndrome (RLS) | Phase 3 | Completed | American Regent, Inc. | 209 | 2015-01-01 | 2021-10-12 |
| Registry to Evaluate Maintenance Treatment With Venofer in Pediatric Patients With Chronic Kidney Disease Chronic Kidney Disease | Completed | American Regent, Inc. | 50 | 2014-09-01 | 2019-06-19 | |
| 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 Injectafer, Ferrous Sulfate tablets - Iron Deficiency Anemia Secondary to IBD or Gastric Bypass | Phase 4 | Completed | American Regent, Inc. | 198 | 2014-01-01 | 2020-09-17 |
| A Comparison of Bone Formation With Three Different Bone Graft Materials Following Sinus Graft Sinus augmentation, Equimatrix, OSSIF-i sem - Inadequate Bone Height in Maxillary Posterior Area | Not applicable | Completed | Loma Linda University | 22 | 2013-12-01 | 2017-12-13 |
| Observational Study on the Use of IV (Intravenous) Iron Therapy Among Subjects With Iron Deficiency Anemia Iron Deficiency Anemia (IDA) | Completed | American Regent, Inc. | 551 | 2013-09-01 | 2018-01-24 | |
| Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron Injectafer, SOC - Iron Deficiency Anemia (IDA) | Phase 4 | Completed | American Regent, Inc. | 1025 | 2013-08-15 | 2025-05-22 |
Showing 20 of 63. Sign in to see all of them.
Anemia (18) · Anemia, Iron-Deficiency (17) · Renal Insufficiency, Chronic (6) · Restless Legs Syndrome (5) · Melanoma (4) · Heart Failure (3) · Emergencies (2) · Iron Deficiencies (2) · Neoplasms (2) · Agnosia (1) · Arthritis, Gouty (1) · Calciphylaxis (1) · Carcinoma, Non-Small-Cell Lung (1) · Congenital Methemoglobinemia (1) · Dysmenorrhea (1)
ferric carboxymaltose (32) · Ferric Oxide, Saccharated (11) · Iron-Dextran Complex (10) · Iron (8) · ferrous sulfate (8) · Docosahexaenoic Acids (5) · Saline Solution (5) · docosahexaenoyl-paclitaxel (5) · Copper (2) · Copper Sulfate (2) · Fosfomycin (2) · Ketorolac (2) · Ketorolac Tromethamine (2) · Selenious Acid (2) · Zinc Sulfate (2)
United States (47) · Poland (3) · Australia (2) · Czechia (2) · New Zealand (2) · Russia (2) · Austria (1) · Belgium (1) · Bulgaria (1) · Canada (1) · Denmark (1) · France (1) · Georgia (1) · Germany (1) · Greece (1)
Mark A Falone, MD (9) · Mark Falone, MD (7) · Khaled Khechen, MD (2) · Lincoln Bynum, MD (2) · Sharon Mace, MD (2) · Adrian F Hernandez, MD (1) · Ahmed Kaseb, M.D. (1) · Carol Duffy, D.O.,FACC (1) · Charles V Pollack, MD (1) · Christopher J. Earley, MD, PhD (1) · David Bregman, M.D, Ph.D. (1) · David Bregman, MD (1) · Debra Diercks, MD (1) · Fareeda Hosein, MD (1) · Iain Macdougall (1)
PMID 17666600, PMID 15824508, PMID 16316362, PMID 18567277, PMID 18752459, PMID 18928998, PMID 19682342, PMID 20929915, PMID 23143939, PMID 23505057, PMID 24891437, PMID 26840902, PMID 28095881, PMID 28339831, PMID 28487769, PMID 29149437, PMID 30051186, PMID 30853478, PMID 32331365, PMID 34003690, PMID 35363499, PMID 35956390, PMID 37208431, PMID 37598795, PMID 37632463, PMID 38250799, PMID 38625730, PMID 39185895, PMID 39443013, PMID 39890013, PMID 41137844
P01AG021190 (1)