Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients
NCT03303144 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2020-11-16
Summary
The main purpose is to establish the equivalence of Triferic iron administered via dialysate into the arterial blood line and into the venous blood line
Conditions
Interventions
- DRUG
-
Triferic
ferric pyrophosphate citrate
Sponsors & Collaborators
-
Rockwell Medical Technologies, Inc.
lead INDUSTRY
Principal Investigators
-
Thomas Marbury · Orlando Clinical Research Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-10-01
- Primary Completion
- 2017-12-28
- Completion
- 2017-12-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis
NCT01191255 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
NCT04042324 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Clinical Trial of Oral Versus IV Iron in Patients With Chronic Kidney Disease
NCT00830037 ·Status: TERMINATED ·Phase: PHASE4
-
Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients
NCT03079869 ·Status: COMPLETED ·Phase: PHASE4
-
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
-
Ferric Citrate in Managing Serum Phosphorus and Iron Deficiency in Anemic Chronic Kidney Disease (CKD) Subjects Not on Dialysis
NCT01736397 ·Status: COMPLETED ·Phase: PHASE2
-
Hemoglobin Maintenance in Pediatric ESRD (End-stage Renal Disease) Patients by Ferric Pyrophosphate Citrate (FPC)
NCT04239391 ·Status: UNKNOWN ·Phase: PHASE3
-
A Single Ascending Dose Study of Soluble Ferric Pyrophosphate Administered Intravenously in Healthy Volunteers.
NCT01920854 ·Status: COMPLETED ·Phase: PHASE1
-
Dose-finding Study of KHK7791 in Hyperphosphatemia Patients
NCT03864458 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Ferric Citrate to Improve Inflammation and Lipid Levels
NCT02661295 ·Status: TERMINATED ·Phase: PHASE4
-
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
-
Study of Phosphate Levels in Patients With Chronic Kidney Disease
NCT00824460 ·Status: COMPLETED ·Phase: PHASE2
-
Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET)
NCT01994733 ·Status: COMPLETED ·Phase: PHASE2
-
Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis
NCT04456803 ·Status: COMPLETED ·Phase: PHASE3
-
Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease
NCT00967993 ·Status: COMPLETED
-
Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered as Single Bolus Injections in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D)
NCT01469078 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)
NCT00648167 ·Status: COMPLETED ·Phase: PHASE2
-
Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis
NCT00548249 ·Status: COMPLETED ·Phase: PHASE2
-
Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in CKD Patients Receiving Chronic Hemodialysis
NCT01503021 ·Status: COMPLETED ·Phase: PHASE3
-
Delivery of Soluble Ferric Pyrophosphate (SFP) Via the Dialysate to Maintain Iron Balance in Hemodialysis Patients
NCT00604565 ·Status: TERMINATED ·Phase: NA
-
Quantitative Mass Transfer of SFP-iron From Dialysate to Blood in CKD-HD Patients
NCT01894906 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients
NCT01320202 ·Status: COMPLETED ·Phase: PHASE3
-
Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2)
NCT01322347 ·Status: COMPLETED ·Phase: PHASE3
-
A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis
NCT01554982 ·Status: COMPLETED ·Phase: PHASE3
-
A Pharmacokinetics and Safety Study in Subjects With Renal Impairment
NCT01452828 ·Status: COMPLETED ·Phase: PHASE1