13 completed, 3 unknown, 1 not yet recruiting, 1 terminated. 11 Phase 4, 5 Phase 3, 2 Phase 2, 1 Not applicable, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 11 | Completed 9, Terminated 1, Unknown 1 |
| Phase 3 | 5 | Completed 3, Not yet recruiting 1, Unknown 1 |
| Phase 2 | 2 | Completed 1, Withdrawn 1 |
| Not applicable | 1 | Unknown 1 |
| Phase 1 | 1 | Completed 1 |
Follow ferric gluconate: new trials by email Literature Review of ferric gluconate trials Research Report on ferric gluconate
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 |
|---|---|---|---|---|---|---|
| Effect of Intravenously Iron Infusion on the Prevention and Treatment of Anemia in Ovarian Cancer IV iron - Anaemia in Ovarian Carcinoma | Phase 3 | Not yet recruiting | University of Saskatchewan | 200 | 2024-02-29 | 2024-02-08 |
| IV Sodium Ferric Gluconate Complex in Patients Undergoing TAVI IV Sodium Ferric Gluconate Complex - Iron Deficiency Anemia Due to Blood Loss, Aortic Stenosis | Phase 4 | Unknown | Rambam Health Care Campus | 200 | 2020-10-18 | 2022-10-27 |
| Clinical Burden of Anemia in Inflammatory Bowel Disease: Therapeutic Trial Sucrosomial iron, Ferric Gluconate, Ferric carboxymaltose - Iron Deficiency Anemia, Inflammatory Bowel Diseases | Phase 3 | Unknown | Fondazione IRCCS Policlinico San Matteo di Pavia | 300 | 2020-01-01 | 2020-10-19 |
| IV Iron in Acute Decompensated Heart Failure IV iron - Sodium Ferric Gluconate Complex - Heart Failure | Phase 4 | Completed | Rambam Health Care Campus | 34 | 2019-09-01 | 2023-04-11 |
| Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure Sodium ferric gluconate - Heart Failure, Iron Deficiency Anemia | Phase 4 | Completed | University of North Carolina, Chapel Hill | 13 | 2011-04-01 | 2015-08-25 |
| Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia Ferric Carboxymaltose, Standard Medical Care (SMC) - Anemia | Phase 3 | Completed | American Regent, Inc. | 735 | 2008-06-01 | 2018-02-20 |
| Comparison Between Effects of Two Iron Preparations on Protein in the Urine iron sucrose injection, USP, sodium ferric gluconate complex in sucrose injection - Kidney Failure, Chronic, Anemia, Iron-Deficiency | Phase 1 | Completed | Watson Pharmaceuticals | 74 | 2007-09-01 | 2011-09-23 |
| Using Iron With Procrit in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia Epoetin Alfa plus Iron - Anemia | Phase 2 | Withdrawn | University of Louisville | 2007-05-01 | 2018-03-05 | |
| Effect of Two Iron Preparations on Protein in the Urine Sodium Ferric Gluconate and Iron sucrose - Kidney Failure, Chronic, Anemia, Iron-Deficiency | Phase 4 | Completed | Watson Pharmaceuticals | 12 | 2006-06-01 | 2012-08-14 |
| Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer darbepoetin alfa, ferrous sulfate, sodium ferric gluconate complex in sucrose - Anemia, Leukemia | Phase 3 | Completed | Mayo Clinic | 502 | 2006-01-01 | 2011-05-17 |
| Serum NGAL Levels in Hemodialysis (HD) Patients; Relation to Iron Status, HD and Intravenous (IV) Iron Administration Iron Saccharate (Venofer) - Renal Failure Chronic Requiring Hemodialysis | Not applicable | Unknown | Soroka University Medical Center | 100 | 2005-12-01 | 2013-04-18 |
| DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin) Sodium ferric gluconate, - Anemia, Iron-Deficiency, Kidney Failure, Chronic | Phase 4 | Completed | Watson Pharmaceuticals | 134 | 2004-09-01 | 2015-12-10 |
| Study of the Efficacy and Safety of Ferrlecit in the Maintenance Dosing in Hemodialysis Patients. Oral Iron, sodium ferric gluconate - Anemia | Phase 4 | Terminated | Sanofi | 112 | 2003-12-30 | 2021-06-24 |
| 2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients. Sodium Ferric Gluconate Complex, Oral Iron - Iron Deficiency Anemia | Phase 2 / Phase 3 | Completed | Watson Pharmaceuticals | 146 | 2003-12-01 | 2013-07-08 |
| Study of the Efficacy of Two Doses of Ferrlecit in the Treatment of Iron Deficiency in Pediatric Hemodialysis Patients Ferrlecit (sodium ferric gluconate complex in sucrose injection) - Anemia | Phase 4 | Completed | Watson Pharmaceuticals | 59 | 2003-06-01 | 2012-08-14 |
| Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Sodium Ferric Gluconate Complex in Sucrose Injection, Ferrous sulfate tablets - Anemia, Iron-Deficiency, Kidney Failure, Chronic | Phase 4 | Completed | Watson Pharmaceuticals | 89 | 2003-04-01 | 2012-03-29 |
| Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients Sodium Ferric Gluconate Complex in Sucrose. - Anemia | Phase 4 | Completed | Watson Pharmaceuticals | 23 | 2003-04-01 | 2009-09-28 |
| Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents Sodium Ferric Gluconate complex in sucrose, Ferrous sulfate tablets - Anemia, Iron-Deficiency, Kidney Failure, Chronic | Phase 4 | Completed | Watson Pharmaceuticals | 52 | 2003-04-01 | 2012-03-29 |
| Effect of Iron Therapy as an Adjunct to Epoetin Alfa in the Anemia of Cancer Chemotherapy Sodium ferric gluconate, ferrous sulfate, standard of care - Anemia | Phase 4 | Completed | Watson Pharmaceuticals | 180 | 2002-05-01 | 2012-03-02 |
Anemia (11) · Anemia, Iron-Deficiency (8) · Iron Deficiencies (5) · Kidney Failure, Chronic (5) · Bronchiolitis Obliterans Syndrome (2) · Heart Failure (2) · Renal Insufficiency (2) · Renal Insufficiency, Chronic (2) · Aortic Valve Stenosis (1) · Burkitt Lymphoma (1) · Colitis, Ulcerative (1) · Crohn Disease (1) · Hodgkin Disease (1) · Immunoblastic Lymphadenopathy (1) · Immunoglobulin Light-chain Amyloidosis (1)
Watson Pharmaceuticals (9) · Rambam Health Care Campus (2) · American Regent, Inc. (1) · Fondazione IRCCS Policlinico San Matteo di Pavia (1) · Mayo Clinic (1) · Sanofi (1) · Soroka University Medical Center (1) · University of Louisville (1) · University of North Carolina, Chapel Hill (1) · University of Saskatchewan (1)
United States (14) · Israel (3) · Puerto Rico (3) · Canada (2) · Mexico (2) · Poland (2) · Russia (2) · Bulgaria (1) · Croatia (1) · India (1) · Italy (1) · Serbia (1)
Gary Hoel, RPh, PhD (3) · Adel R. Rizkala, Pharm.D., MS (2) · Erez Marcusohn, MD (2) · Naomi V. Dahl, Pharm.D. (2) · Adel R Rizkala, PharmD, MS (1) · Antonio Di Sabatino, MD (1) · Charles L. Loprinzi, MD (1) · David Tovbin, MD (1) · Goetz H Kloecker, MD (1) · Jo Ellen Rodgers, PharmD (1) · Maryam Al-Hayki (1) · Naomi Dahl, Pharm.D. (1) · Tom R. Fitch, M.D. (1)
PMID 16520948, PMID 17035697, PMID 17267740, PMID 17296819, PMID 17396118, PMID 17622274, PMID 18216316, PMID 19034302, PMID 20876669, PMID 35503997, PMID 41870899
P30CA015083 (1)