Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in CKD Patients Receiving Chronic Hemodialysis
NCT ID: NCT01503021
Last Updated: 2016-10-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
718 participants
INTERVENTIONAL
2011-11-30
2014-01-31
Brief Summary
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The purpose of the extension study is to assess the long-term safety and tolerability of SFP.
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Detailed Description
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Extension Study: open-label, single active arm, uncontrolled study, up to 53 weeks, 300 patients. Following completion of the RMTI-SFP-6 parent study, patients could enter the extension study, where they received SFP 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate for up to 52 weeks.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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SFP/Placebo
Soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks
SFP
Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate
Placebo
Dialysis with standard liquid bicarbonate concentrate without iron
Placebo/SFP
Standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks.
SFP
Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate
Placebo
Dialysis with standard liquid bicarbonate concentrate without iron
Interventions
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SFP
Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate
Placebo
Dialysis with standard liquid bicarbonate concentrate without iron
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Has chronic kidney disease (CKD) receiving maintenance hemodialysis (HD) (CKD-HD subjects) and regularly undergoing 2 or more dialysis sessions per week.
3. Stable pre-dialysis Hgb ≥ 9.0 to ≤ 12.5 g/dL.
4. Stable pre-dialysis TSAT ≥ 15% to ≤ 45%.
5. Stable pre-dialysis ferritin ≥ 100 to ≤ 1200 µg/L (1200 ng/mL).
1. Participated in Parent Study RMTI-SFP-6 and completed the follow-up/early term visit.
2. Hemoglobin ≤12.0 g/dL at screening.
Exclusion Criteria
2. Therapy with intravenous, intramuscular or oral iron at any time between the first/screening visit and the randomization visit, or anticipated requirement for iron supplementation during the study period.
3. Non-tunneled vascular catheter for dialysis.
4. Scheduled for kidney transplant within the next 8 weeks.
5. Active infection requiring systemic antimicrobial or antifungal therapy within 2 weeks prior to screening, or during screening period prior to randomization.
6. Hospitalization within 1 month prior to screening (except for vascular access surgery).
Extension Study, Open Label, Single Active Arm:
1. Had a serious adverse event attributable (i.e., probably, possibly, or definitely related) to study drug or had an adverse event attributable to study drug that necessitated premature withdrawal from the double-blind, placebo-controlled crossover phase of the parent study RMTI-SFP-6.
2. Non-tunneled vascular catheter for dialysis.
3. Scheduled for kidney transplant within 12 weeks after entry into extension phase.
4. Active infection requiring systemic antimicrobial or antifungal therapy within 2 weeks prior to dosing.
5. Pregnancy or intention to become pregnant during the study.
18 Years
ALL
No
Sponsors
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Rockwell Medical Technologies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ray Pratt, MD
Role: STUDY_DIRECTOR
Rockwell Medical, Inc
Locations
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Mobile, Alabama, United States
Northridge, California, United States
Arvada, Colorado, United States
Westminster, Colorado, United States
Lauderhill, Florida, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Peoria, Illinois, United States
Columbus, Indiana, United States
Wichita, Kansas, United States
Baton Rouge, Louisiana, United States
Shreveport, Louisiana, United States
Camp Springs, Maryland, United States
Gulfport, Mississippi, United States
McComb, Mississippi, United States
Tupelo, Mississippi, United States
City of Saint Peters, Missouri, United States
Lincoln, Nebraska, United States
Reno, Nevada, United States
Rocky Mount, North Carolina, United States
Dayton, Ohio, United States
Columbia, South Carolina, United States
Research Across America
Houston, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
Mission, Texas, United States
Temple, Texas, United States
Tyler, Texas, United States
Courtice, Ontario, Canada
Montreal, Quebec, Canada
Regina, Saskatchewan, Canada
Countries
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Other Identifiers
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RMTI-SFP-6
Identifier Type: -
Identifier Source: org_study_id
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