Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in CKD Patients Receiving Chronic Hemodialysis

NCT01503021 | Completed Phase 3 Results

• 1 other identifier: RMTI-SFP-6
• Study Type: interventional
• Target: 718
• Locations: 2 countries
• Sites: 31

Brief Summary

The purpose of the parent study is to assess the short-term safety and tolerability of soluble ferric pyrophosphate (SFP) in dialysate administered to a large number of representative adult chronic kidney disease patients on hemodialysis (CKD-HD). The purpose of the extension study is to assess the long-term safety and tolerability of SFP.

Conditions

End Stage Renal Disease; Chronic Kidney Disease

Keywords

Soluble ferric pyrophosphate; Chronic kidney disease; Chronic hemodialysis; Ferric pyrophosphate citrate

Outcome Measures

Primary Outcomes (3)

• Incidence of Treatment-emergent Adverse Events

  Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention.

  Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study

• Incidence of Treatment-emergent Adverse Events of Intradialytic Hypotension

  Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met the protocol criteria for intradialytic hypotension. Intradialytic hypotension events were only to have been reported as adverse events if they exceeded the individual subject's baseline pattern of intradialytic hypotension.

  Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study

• Incidence of Related Suspected Hypersensitivity Reactions

  Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met protocol criteria for suspected hypersensitivity reactions.

  Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study

Secondary Outcomes (5)

• Incidence of Composite Cardiovascular Events

  Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study

• Incidence of Hemodialysis Vascular Access Thrombotic Events

  Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study

• Incidence of Other Thrombotic Events

  Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study

• Incidence of Systemic/Serious Infections

  Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study

• Incidence of Serious Adverse Events

  Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study

Other Outcomes (10)

• Serum Iron Change From Pre-dialysis to Post-dialysis at Week 2

  Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study

• Serum Iron Change From Pre-dialysis to Post-dialysis at Week 5

  Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study

• Unsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 2

  Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study

Study Arms (2)

SFP/Placebo

OTHER

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

Drug: SFP; Other: Placebo

Placebo/SFP

OTHER

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.

Drug: SFP; Other: Placebo

Interventions

SFP DRUG

Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate

Also known as: Soluble ferric pyrophosphate

Placebo/SFP; SFP/Placebo

Placebo OTHER

Dialysis with standard liquid bicarbonate concentrate without iron

Also known as: Standard liquid bicarbonate concentrate

Placebo/SFP; SFP/Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult ≥ 18 years of age.
• Has chronic kidney disease (CKD) receiving maintenance hemodialysis (HD) (CKD-HD subjects) and regularly undergoing 2 or more dialysis sessions per week.
• Stable pre-dialysis Hgb ≥ 9.0 to ≤ 12.5 g/dL.
• Stable pre-dialysis TSAT ≥ 15% to ≤ 45%.
• Stable pre-dialysis ferritin ≥ 100 to ≤ 1200 µg/L (1200 ng/mL).

You may not qualify if:

• Any previous exposure to SFP.
• 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.
• Non-tunneled vascular catheter for dialysis.
• Scheduled for kidney transplant within the next 8 weeks.
• Active infection requiring systemic antimicrobial or antifungal therapy within 2 weeks prior to screening, or during screening period prior to randomization.
• Hospitalization within 1 month prior to screening (except for vascular access surgery).
• Extension Study, Open Label, Single Active Arm:
• Participated in Parent Study RMTI-SFP-6 and completed the follow-up/early term visit.
• Hemoglobin ≤12.0 g/dL at screening.
• 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.
• Non-tunneled vascular catheter for dialysis.
• Scheduled for kidney transplant within 12 weeks after entry into extension phase.
• Active infection requiring systemic antimicrobial or antifungal therapy within 2 weeks prior to dosing.
• Pregnancy or intention to become pregnant during the study.

Sponsors & Collaborators

• Rockwell Medical Technologies, Inc.: lead

Study Sites (31)

Unknown Facility

Mobile, Alabama, 36688, United States

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Northridge, California, 91324, United States

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Arvada, Colorado, 80002, United States

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Westminster, Colorado, 80031, United States

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Lauderhill, Florida, 33319, United States

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Marietta, Georgia, 30060, United States

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Chicago, Illinois, 60616, United States

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Peoria, Illinois, 61603, United States

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Columbus, Indiana, 47201, United States

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Wichita, Kansas, 67214, United States

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Baton Rouge, Louisiana, 70808, United States

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Shreveport, Louisiana, 71101, United States

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Camp Springs, Maryland, 20748, United States

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Gulfport, Mississippi, 39501, United States

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McComb, Mississippi, 39648, United States

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Tupelo, Mississippi, 38801, United States

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City of Saint Peters, Missouri, 63376, United States

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Lincoln, Nebraska, 68510, United States

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Reno, Nevada, 89511, United States

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Rocky Mount, North Carolina, 27804, United States

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Dayton, Ohio, 45428, United States

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Columbia, South Carolina, 29209, United States

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Research Across America

Houston, Texas, 75234, United States

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Houston, Texas, 77051, United States

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Irving, Texas, 75061, United States

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Mission, Texas, 78572, United States

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Temple, Texas, 76508, United States

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Tyler, Texas, 75701, United States

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Courtice, Ontario, L1E 3C3, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Regina, Saskatchewan, 54P 0W5, Canada

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic

Interventions

spleen fibrinolytic proteinase (human)

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Director, Clinical Research
• Organization: Rockwell Medical, Inc

rd@rockwellmed.com

248-960-9009

Study Officials

• Ray Pratt, MD

  Rockwell Medical, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2011
• First Posted: January 2, 2012
• Study Start: November 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 25, 2016
• Results First Posted: April 21, 2015

Record last verified: 2016-09

Locations

CA (3); US (28)