AMERICAN REGENT, INC.

🇺🇸United States

Country: 🇺🇸United States

Ownership: Subsidiary

Established: 1967-01-01

Employees: 501

Market Cap: -

Website: http://www.americanregent.com

Clinical Trials

Safety and Tolerability of 200mg and 100mg of Venofer Administered to Hemodialysis(HD) Patients

Phase 4

Completed

Conditions: Hemodialysis

Interventions: Drug: Venofer® 200 mg
Drug: Venofer® 100 mg

First Posted Date: 2024-11-15

Last Posted Date: 2024-11-15

Lead Sponsor: American Regent, Inc.

Target Recruit Count: 400

Registration Number: NCT06690450

Tralement vs. Fixed-dose Trace Element Combination Product in Patients >3 to 17 Years of Age Requiring Long-term PN

Phase 4

Withdrawn

Conditions: Manganese Safety in Pediatric Patients

Interventions: Drug: Tralement
Drug: Fixed-dose trace element combination product of zinc, copper, and selenious acid

First Posted Date: 2023-01-10

Last Posted Date: 2024-11-15

Lead Sponsor: American Regent, Inc.

Target Recruit Count: 80

Registration Number: NCT05677126

Tralement Versus a Fixed-dose Trace Element Combination Product of Zinc, Copper, and Selenious Acid to Evaluate Product Safety in Adult Patients Requiring Long-term Parenteral Nutrition

Phase 4

Not yet recruiting

Conditions: Manganese Safety in Adults

Interventions: Drug: Tralement
Drug: Fixed-dose trace element combination product of zinc, copper, and selenious acid

First Posted Date: 2022-12-22

Last Posted Date: 2023-08-24

Lead Sponsor: American Regent, Inc.

Target Recruit Count: 108

Registration Number: NCT05661682

Safety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With Iron Deficiency Anemia

Phase 2

Withdrawn

Conditions: Iron Deficiency, Anaemia

Interventions: Drug: Ferric carboxymaltose

First Posted Date: 2021-07-20

Last Posted Date: 2023-01-06

Lead Sponsor: American Regent, Inc.

Registration Number: NCT04968379

Locations: 🇺🇸
St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States
🇺🇸
University of Iowa, Iowa City, Iowa, United States
🇺🇸
Cohen Children's Medical Center, New Hyde Park, New York, United States

and more 1 locations

Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia and Unsatisfactory Response Oral Iron Under Study Protocol 1VIT17044

Phase 3

Completed

Conditions: Iron Deficiency Anemia

Interventions: Drug: Ferric carboxymaltose

First Posted Date: 2020-02-17

Last Posted Date: 2022-03-21

Lead Sponsor: American Regent, Inc.

Target Recruit Count: 7

Registration Number: NCT04269707

Locations: 🇺🇸
South Florida Research Phase I-IV, Miami Springs, Florida, United States
🇺🇸
Miami Clinical Research, Miami, Florida, United States

Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA

Phase 3

Completed

Conditions: Iron Deficiency Anemia

Interventions: Drug: Ferrous Sulfate
Drug: Ferric carboxymaltose

First Posted Date: 2018-05-14

Last Posted Date: 2022-06-22

Lead Sponsor: American Regent, Inc.

Target Recruit Count: 79

Registration Number: NCT03523117

Locations: 🇺🇸
ProHealth Research Center, Doral, Florida, United States
🇺🇸
Garden Medical Research, Inc., Miami, Florida, United States
🇺🇸
Miami Clinical Research, Miami, Florida, United States

and more 13 locations

Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study

Phase 3

Completed

Conditions: Iron-deficiency
Heart Failure

Interventions: Drug: Placebo
Drug: Ferric Carboxymaltose

First Posted Date: 2017-01-31

Last Posted Date: 2024-07-03

Lead Sponsor: American Regent, Inc.

Target Recruit Count: 3065

Registration Number: NCT03037931

Locations: 🇺🇸
NEA Baptist Clinic, Jonesboro, Arkansas, United States
🇺🇸
Richmond University Medical Center, Staten Island, New York, United States
🇦🇺
SWSLHD-Liverpool Hospital, Liverpool, New South Wales, Australia

and more 338 locations

Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia

Phase 2

Terminated

Conditions: Restless Legs Syndrome (RLS)

Interventions: Drug: Placebo (Normal Saline)
Drug: Injectafer® (Ferric Carboxymaltose - FCM)

First Posted Date: 2016-07-11

Last Posted Date: 2022-09-14

Lead Sponsor: American Regent, Inc.

Target Recruit Count: 70

Registration Number: NCT02826681

Locations: 🇺🇸
Neurology Center of Las Vegas, Las Vegas, Nevada, United States
🇺🇸
Synergy San Diego, Lemon Grove, California, United States
🇺🇸
Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States

and more 5 locations

Randomized Double Blind Placebo Controlled Trial of Sodium Thiosulfate for the Treatment of Pain Associated With Calcific Uremic Arteriolopath

Phase 3

Terminated

Conditions: Calciphylaxis
Calcific Uremic Arteriolopathy

Interventions: Drug: Sodium thiosulfate
Drug: Placebo

First Posted Date: 2015-08-18

Last Posted Date: 2017-01-23

Lead Sponsor: American Regent, Inc.

Target Recruit Count: 40

Registration Number: NCT02527213

Locations: 🇺🇸
Nephrology Association of Northern Indiana, Fort Wayne, Indiana, United States
🇺🇸
Nephrology Consultants, Huntsville, Alabama, United States
🇺🇸
A.A. Northeast Clinical Research Center, Bethlehem, Pennsylvania, United States

Registry to Evaluate Maintenance Treatment With Venofer in Pediatric Patients With Chronic Kidney Disease

Completed

Conditions: Chronic Kidney Disease

First Posted Date: 2015-07-09

Last Posted Date: 2019-06-19

Lead Sponsor: American Regent, Inc.

Target Recruit Count: 50

Registration Number: NCT02492672

Locations: 🇺🇸
Cleveland Clinic Foundation, Cleveland, Ohio, United States
🇺🇸
East Carolina University, Greenville, North Carolina, United States
🇺🇸
University of Miami, Miami, Florida, United States

and more 6 locations

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