A Single Ascending Dose Study of Soluble Ferric Pyrophosphate Administered Intravenously in Healthy Volunteers.
NCT01920854 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2015-01-26
Summary
The purpose of this study is to determine the pharmacokinetics of fixed ascending doses of intravenously administered Soluble Ferric Pyrophosphate
Conditions
- Kidney Failure, Chronic Therapy; Hemodialysis
Interventions
- DRUG
-
soluble ferric pyrophosphate
- DRUG
Sponsors & Collaborators
-
Rockwell Medical Technologies, Inc.
lead INDUSTRY
Principal Investigators
-
Raymond D Pratt, MD FACP · Rockwell Medical Inc
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-06-30
- Primary Completion
- 2013-09-30
- Completion
- 2013-09-30
Countries
- United States
Study Locations
More Related Trials
-
Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients
NCT01286012 ·Status: COMPLETED ·Phase: PHASE2
-
Dose-finding Study of KHK7791 in Hyperphosphatemia Patients
NCT03864458 ·Status: COMPLETED ·Phase: PHASE2
-
Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients
NCT03864445 ·Status: COMPLETED ·Phase: PHASE2
-
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease
NCT01503736 ·Status: COMPLETED ·Phase: PHASE3
-
Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2)
NCT01322347 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Ferric Citrate to Improve Inflammation and Lipid Levels
NCT02661295 ·Status: TERMINATED ·Phase: PHASE4
-
A Phase 3 Clinical Trial of Intravenous Sodium Thiosulfate in Acute Calciphylaxis Patients
NCT03150420 ·Status: TERMINATED ·Phase: PHASE3
-
Study of Phosphate Levels in Patients With Chronic Kidney Disease
NCT00824460 ·Status: COMPLETED ·Phase: PHASE2
-
A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis
NCT01191255 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease Patients Not on Dialysis
NCT00833768 ·Status: TERMINATED ·Phase: PHASE3
-
A Study to Evaluate Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD)
NCT03548220 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis
NCT02909153 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis
NCT01742585 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomized, Comparative, Open-label Study of IV Monofer® Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With IV Iron Sucrose in Subjects With CKD-5D
NCT01222884 ·Status: COMPLETED ·Phase: PHASE3
-
Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients
NCT03303144 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Renal Impairment Study of PF-06700841
NCT04260464 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess Fixed Dosing of AMG 223 in Subjects With Chronic Kidney Disease on Hemodialysis With Hyperphosphatemia
NCT00530114 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety Study of Magnesium Iron Hydroxycarbonate for the Reduction of High Blood Phosphate in Hemodialysis Patients
NCT00317694 ·Status: COMPLETED ·Phase: PHASE2
-
A Single Dose Study Investigating the Elimination as Well as the Tolerability of PD 0332334 in Healthy Subjects as Compared to Patients With Impaired Kidney Function.
NCT00721422 ·Status: TERMINATED ·Phase: PHASE1
-
Dose Finding Study to Treat High Phosphate Levels in the Blood.
NCT02081534 ·Status: COMPLETED ·Phase: PHASE2
-
Ferric Citrate in Managing Serum Phosphorus and Iron Deficiency in Anemic Chronic Kidney Disease (CKD) Subjects Not on Dialysis
NCT01736397 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis
NCT01750190 ·Status: COMPLETED ·Phase: PHASE3
-
A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease
NCT01074125 ·Status: COMPLETED ·Phase: PHASE3
-
Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis
NCT03984760 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetics and Preliminary Bioequivalence of Triferic (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients
NCT02739100 ·Status: COMPLETED ·Phase: PHASE1