Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients
Public ClinicalTrials.gov record NCT01286012. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Physiological Iron Maintenance in End Stage Renal Disease (ESRD) Subjects by Delivery of Soluble Ferric Pyrophosphate (SFP) Via Hemodialysate: The PRIME Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to compare the clinical safety and efficacy of SFP in sparing the need for erythropoiesis stimulating agents (ESAs) required to maintain hemoglobin (hgb) levels in chronic hemodialysis subjects who receive SFP via the dialysate versus subjects who receive conventional dialysate without iron.
Study identification
- NCT ID
- NCT01286012
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 108 participants
Conditions and interventions
Conditions
Interventions
- Soluble Ferric Pyrophosphate in liquid bicarbonate Drug
- Placebo: Conventional liquid bicarbonate Drug
- Erythrocyte Stimulating Agent (ESA) Drug
- Intravenous (IV) Iron Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2011 (Type not available)
- Primary completion
- Jan 2013 (Actual)
- Completion
- Jan 2013 (Actual)
- Last update posted
- Oct 1, 2018
2011 – 2013
United States locations
- U.S. sites
- 22
- U.S. states
- 17
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigator | Birmingham | Alabama | 35211 | — |
| Investigator | Tempe | Arizona | 85284 | — |
| Investigator | Granada Hills | California | 91344 | — |
| Investigator | Colorado Springs | Colorado | 80909 | — |
| Investigator | Miami | Florida | 33128 | — |
| Investigator | Miami | Florida | 33173 | — |
| Investigator | Albany | Georgia | 31702 | — |
| Investigator | Hayden | Idaho | 83835 | — |
| Investigator | Louisville | Kentucky | 40202 | — |
| Investigator | New Orleans | Louisiana | 70122 | — |
| Investigator | Columbus | Mississippi | 39705 | — |
| Investigator | Kansas City | Missouri | 64114 | — |
| Investigator | Las Vegas | Nevada | 89120 | — |
| Investigator | Paterson | New Jersey | 07503 | — |
| Investigator | Lexington | North Carolina | 27292 | — |
| Investigator | Columbia | Tennessee | 38401 | — |
| Investigator | Duncanville | Texas | 75137 | — |
| Investigator | Greenville | Texas | 75402 | — |
| Investigator | San Antonio | Texas | 78215 | — |
| Investigator | San Antonio | Texas | 78221 | — |
| Investigator | St. George | Utah | 84770 | — |
| Investigator | Taylorsville | Utah | 84118 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01286012, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 1, 2018 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01286012 live on ClinicalTrials.gov.