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Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2)

NCT01322347 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2017-04-26

Study results available
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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).

Conditions

  • Renal Failure Chronic Requiring Hemodialysis

Interventions

DRUG

Soluble Ferric Pyrophosphate (SFP)

Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months.

DEVICE

Standard dialysate

Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week.

Sponsors & Collaborators

  • Rockwell Medical Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Ray Pratt, MD · Rockwell Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2014-01-31
Completion
2014-02-28

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01322347 on ClinicalTrials.gov