Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-03-05 @ 8:51 AM
Study NCT ID:
NCT01320202
Status:
COMPLETED
Last Update Posted:
2017-04-26
First Post:
2011-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients
Sponsor:
Rockwell Medical Technologies, Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRUISE 1
Brief 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).
Detailed 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Stage 2 (Randomized Blinded Treatment): 12 months unless withdrawn prematurely.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.
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Stage 2 (Randomized Blinded Treatment): 12 months unless withdrawn prematurely.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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: