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

NCT01320202 | Completed Phase 3 Results DMC

• 1 other identifier: RMTI-SFP-4
• Study Type: interventional
• Target: 305
• Locations: 2 countries
• Sites: 47

Brief 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

Keywords

End Stage Renal Disease; Hemodialysis; SFP; Hemodialysis-dependent chronic renal failure

Outcome Measures

Primary Outcomes (2)

• Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean

  Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean with standard error.

  Hgb measured weekly; up to 48 weeks from the date of randomization

• Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hgb

  Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation).

  Hgb measured weekly; up to 48 weeks from the date of randomization

Secondary Outcomes (13)

• Mean Change in Serum Iron From Pre-dialysis to Post-dialysis.

  Up to 48 weeks from the date of randomization

• Mean Change in TSAT (Transferrin) From Pre-dialysis to Post-dialysis.

  Up to 48 weeks from the date of randomization

• Mean Change in Unsaturated Iron Binding Capacity (UIBC) From Pre- to Post-dialysis.

  Up to 48 weeks from the date of randomization

• Red Blood Cell or Whole Blood Transfusion: Number of Patients Receiving Transfusion

  up to 48 weeks from the date of randomization

• Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused

  up to 48 weeks from the date of randomization

Study Arms (2)

Soluble Ferric Pyrophosphate (SFP) in dialysate

ACTIVE COMPARATOR

11 micrograms (µg) of iron / deciliter (dL) of dialysate.

Drug: Soluble Ferric Pyrophosphate (SFP)

Standard Dialysate

PLACEBO COMPARATOR

0 micrograms (µg) of iron / deciliter (dL) of dialysate.

Device: Standard dialysate

Interventions

Soluble Ferric Pyrophosphate (SFP) DRUG

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

Soluble Ferric Pyrophosphate (SFP) in dialysate

Standard dialysate DEVICE

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

Standard Dialysate

Eligibility Criteria

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

You may qualify if:

• Adult subject ≥ 18 years of age undergoing chronic hemodialysis three or four times per week for chronic kidney disease (CKD) for at least 4 months, and expected to remain on hemodialysis three to four times weekly and be able to complete the duration of the study.
• Received IV iron therapy between 6 months and 2 weeks prior to enrollment in order to replace iron losses resulting from hemodialysis procedure.
• Mean Screening Hgb ≥ 9.5 to ≤ 11.5 grams per deciliter (g/dL).
• Mean Screening Transferrin Saturation (TSAT) ≥ 15% to ≤ 40%.
• Mean Screening serum ferritin ≥ 200 to ≤ 800 micrograms per liter (µg/L).
• If being administered epoetin, darbepoetin, or CERA, epoetin dose ≤ 45,000 Units (U)/week, darbepoetin dose ≤ 200 micrograms (µg)/week, or CERA dose ≤ 400 micrograms (µg)/month during the four weeks prior to enrollment.

You may not qualify if:

• Patient has living kidney donor identified or living-donor kidney transplant scheduled. (Note: Patients awaiting deceased-donor transplant need not be excluded.)
• Vascular access for dialysis with femoral catheter or non-tunneled catheter.
• Received a total of \> 800 milligrams (mg) IV iron during the 8 weeks prior to enrollment
• If being administered an ESA, route of administration change or ESA dose change \> 35% (i.e., \[max - min dose\]/max dose \> 0.35) over the 2 weeks prior to screening.
• Serum albumin \< 3.0 grams per deciliter (g/dL) any time over the 8 weeks prior to enrollment.
• Red Blood Cell (RBC) or whole blood transfusion within 12 weeks prior to enrollment.
• Stage 2:
• Patient currently enrolled in the Stage 1 run-in period of study.
• Undergoing chronic hemodialysis three or four times per week for chronic kidney disease (CKD), and expected to remain on hemodialysis three to four times weekly and be able to complete duration of the study.
• Mean Hgb ≥ 9.5 to ≤ 11.5 g/dL over the three most recent consecutive every-week measurements prior to randomization.
• Stable Hgb defined as ≤ 1.0 g/dL difference between the maximum and minimum Hgb values over the 3 weeks immediately prior to randomization.
• Mean TSAT ≥ 15% to ≤ 40% over the two most recent consecutive every-other-week measurements prior to randomization.
• Mean serum ferritin ≥ 200 to ≤ 800 µg/L over the two most recent consecutive every-other-week measurements prior to randomization.
• If being administered epoetin, darbepoetin, or CERA, epoetin dose ≤ 45,000 U/week, darbepoetin dose ≤ 200 µg/week, or CERA dose ≤ 400 µg/month during the four weeks prior to randomization.
• Patient has living kidney donor identified or living-donor kidney transplant scheduled. (Note: Patients awaiting deceased-donor transplant need not be excluded.)

Sponsors & Collaborators

• Rockwell Medical Technologies, Inc.: lead

Study Sites (47)

Unknown Facility

Bakersfield, California, 93308, United States

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Investigative Site

Chula Vista, California, 91910, United States

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Cudahy, California, 90201, United States

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Downey, California, 90240, United States

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Encino, California, 91316, United States

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Los Angeles, California, 90022, United States

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Los Angeles, California, 90033, United States

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Los Angeles, California, 90057, United States

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Los Angeles, California, 90404, United States

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National City, California, 91950, United States

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Northridge, California, 91324, United States

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Ontario, California, 91764, United States

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Panorama City, California, 91402, United States

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Riverside, California, 92505, United States

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San Dimas, California, 91773, United States

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Simi Valley, California, 93065, United States

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West Covina, California, 91792, United States

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Yuba City, California, 95991, United States

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Investigative Site

Waterbury, Connecticut, 06708, United States

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Waterbury, Connecticut, 06708, United States

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Coral Springs, Florida, 33071, United States

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Miami, Florida, 33150, United States

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Investigative Site

Augusta, Georgia, 30901, United States

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Chicago, Illinois, 60617, United States

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Michigan City, Indiana, 46360, United States

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Detroit, Michigan, 48202, United States

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Las Vegas, Nevada, 89102, United States

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Investigative Site

Mineola, New York, 11501, United States

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Investigative Site

Ridgewood, New York, 11385, United States

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Rosedale, New York, 11422, United States

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Yonkers, New York, 10704, United States

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Asheville, North Carolina, 28801, United States

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Durham, North Carolina, 27704, United States

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Winston-Salem, North Carolina, 27105, United States

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Cincinnati, Ohio, 45206, United States

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Toledo, Ohio, 43613, United States

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Sumter, South Carolina, 29150, United States

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Chattanooga, Tennessee, 37404, United States

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Arlington, Texas, 76011, United States

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Unknown Facility

Fort Worth, Texas, 76164, United States

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Investigative Site

Houston, Texas, 77004, United States

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Unknown Facility

Houston, Texas, 77081, United States

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Unknown Facility

San Antonio, Texas, 78207, United States

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Unknown Facility

Fairfax, Virginia, 22030, United States

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Shorewood, Wisconsin, 53211, United States

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Unknown Facility

Caguas, 00725, Puerto Rico

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Unknown Facility

Carolina, 00987, Puerto Rico

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Related Publications (1)

• Fishbane SN, Singh AK, Cournoyer SH, Jindal KK, Fanti P, Guss CD, Lin VH, Pratt RD, Gupta A. Ferric pyrophosphate citrate (Triferic) administration via the dialysate maintains hemoglobin and iron balance in chronic hemodialysis patients. Nephrol Dial Transplant. 2015 Dec;30(12):2019-26. doi: 10.1093/ndt/gfv277. Epub 2015 Jul 13.

  PMID: 26175145 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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 & Operations
• Organization: Rockwell Medical

rd@rockwellmed.com

248-960-9009

Study Officials

• Ray Pratt, MD

  Rockwell Medical

  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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2011
• First Posted: March 22, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 26, 2017
• Results First Posted: April 28, 2015

Record last verified: 2017-04

Locations

US (45); PR (2)