Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01320202

Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients — CRUISE 1  

Renal Failure Chronic Requiring Hemodialysis Clinical Trial

Official title:
A Randomized, Placebo-Controlled, Phase III Study of Dialysate Containing Soluble Ferric Pyrophosphate (SFP) in Chronic Kidney Disease Patients Receiving Hemodialysis: The Continuous Replacement Using Iron Soluble Equivalents (CRUISE 1) Study

Clinical Trial Summary

The purpose of this study is to confirm the safety and efficacy of Soluble Ferric Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in anemic adult patients with chronic kidney disease (CKD) receiving hemodialysis. Efficacy will be measured primarily by the change from baseline in hemoglobin (Hgb).

Clinical Trial Description

Screening: 2-3 weeks prior to enrollment in Stage 1.

Stage 1 (Run-In): 1-4 weeks depending on qualification for Stage 2.

Stage 2 (Randomized Blinded Treatment): 12 months unless withdrawn prematurely.

Stage 3 (Open-Label Treatment): The duration of Stage 2 plus Stage 3 is intended to be 18 months regardless of treatment assignment in Stage 2. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01320202
Study type Interventional
Source Rockwell Medical Technologies, Inc.
Contact
Status Completed
Phase Phase 3
Start date March 2011
Completion date November 2013
View Details
See also
  Status Clinical Trial Phase
Completed NCT01947673 - Mechanisms of Intradialytic Hypertension N/A
Not yet recruiting NCT03634904 - Serum Ceftazidime Concentrations in Hemodialysis Patients N/A
Terminated NCT01982864 - Pharmacokinetics of an Aminoglycoside in Hemodialysis Patients. Phase 4
Completed NCT01448174 - Salusin-alpha - a New Factor in the Pathogenesis of Lipid Abnormalities in Hemodialysis Patients Phase 4
Completed NCT01421771 - Blood Pressure in Dialysis Patients N/A
Completed NCT01722695 - Performance Comparison of Revaclear With Larger Dialyzer N/A
Withdrawn NCT01015313 - Effects of Intensified Sodium Management in Hemodialysis Patients N/A
Not yet recruiting NCT02452788 - Pharmaceutical Care in Ambulatory Hemodialysis Patients N/A
Completed NCT02259413 - Effect of an Exercise Rehabilitation Program on Symptoms in Hemodialysis N/A
Recruiting NCT01356563 - Efficacy Study of Pharmacist Intervention on Medication-related Problems in Hemodialysis Patients N/A
Completed NCT01181544 - A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis N/A
Completed NCT02285075 - Temocillin Pharmacokinetic in Hemodialysis Phase 4
Completed NCT02825589 - BIA-Guided Dry Weight Assessment on Sleep Quality in Chronic Hemodialysis Patients N/A
Completed NCT00890045 - Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study N/A
Not yet recruiting NCT02264964 - Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis N/A
Completed NCT01214928 - Hemodialysis Vitamin D Pilot N/A
Terminated NCT01312441 - Sustainability of Vitamin D Levels After Repletion With Ergocalciferol In Chronic Kidney Disease Stage 5D Phase 4
Completed NCT00967993 - Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease Phase 2
Completed NCT01981603 - Transplant Navigator Dissemination N/A
Completed NCT01578421 - Investigation on the Middle Size Molecule Elimination Characteristics of the FXCorDiax 100 in Relation to the FX 100 and the Polyflux 210 H Dialyser N/A