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NCT01322347 · ClinicalTrials.gov registry record · Phase 3
Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2)
A Phase 3 study, sponsored by Rockwell Medical Technologies.
- Completed
- Registry status
- Phase 3
- Development phase
- 294
- Enrollment target
NCT01322347 is a Phase 3 study that has completed, run by Rockwell Medical Technologies. The registered enrollment target is 294 participants.
The verdict
NCT01322347, a Phase 3 study, has completed, sponsored by Rockwell Medical Technologies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 294 participants
- Enrollment target
Study 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).
Interventions
- DRUG Soluble Ferric Pyrophosphate (SFP)
- DEVICE Standard dialysate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 294 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01322347
The ClinicalTrials.gov registry entry for NCT01322347 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 294 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rockwell Medical Technologies, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Soluble Ferric Pyrophosphate (SFP) is the first listed.
NCT01322347 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01322347 about?
NCT01322347 is a clinical study titled "Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2)". 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 chang...
What is the current status of trial NCT01322347?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 294 participants. The study started on 2011-04. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01322347?
The interventions under investigation include: Soluble Ferric Pyrophosphate (SFP) (DRUG), Standard dialysate (DEVICE).
Who is sponsoring clinical trial NCT01322347?
This trial is sponsored by Rockwell Medical Technologies, which has 15 total clinical trials registered on ClinicalTrials.gov.
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