Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2)

NCT01322347 | Completed Phase 3 Results DMC

• 1 other identifier: RMTI-SFP-5
• Study Type: interventional
• Target: 294
• Locations: 2 countries
• Sites: 40

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, along with standard error.

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

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

  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 date of randomization

Secondary Outcomes (13)

• Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis

  Up to 48 weeks from date of randomization

• Mean Change in Transferrin Saturation From Pre-Dialysis to Post-Dialysis

  Up to 48 weeks from date of randomization

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

  Up to 48 weeks from date of randomization

• Red Blood Cell or Whole Blood Transfusion: Number of Patients Who Received a Transfusion

  Up to 48 weeks from date of randomization

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

  Up to 48 weeks from 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 (40)

Investigator

Paragould, Arkansas, 72450, United States

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Pine Bluff, Arkansas, 71603, United States

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Alhambra, California, 91801, United States

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Beverly Hills, California, 90211, United States

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Glendale, California, 91204, United States

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La Mesa, California, 91942, United States

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Long Beach, California, 90807, United States

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Lynwood, California, 90262, United States

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Paramount, California, 90723, United States

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Whittier, California, 90603, United States

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Pembroke Pines, Florida, 33025, United States

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Augusta, Georgia, 30901, United States

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Macon, Georgia, 31217, United States

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Meridian, Idaho, 83642, United States

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Hines, Illinois, 60141, United States

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Rockville, Maryland, 20850, United States

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Detroit, Michigan, 48236, United States

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Pontiac, Michigan, 48341, United States

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Southfield, Michigan, 48034, United States

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Eatontown, New Jersey, 07724, United States

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Brooklyn, New York, 11212, United States

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Fresh Meadows, New York, 11365, United States

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Great Neck, New York, 11021, United States

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Orchard Park, New York, 14127, United States

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The Bronx, New York, 10461, United States

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Bethany, Oklahoma, 73008, United States

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Bethlehem, Pennsylvania, 18017, United States

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Philadelphia, Pennsylvania, 19106, United States

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Philadelphia, Pennsylvania, 19144, United States

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Nashville, Tennessee, 37205, United States

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Nashville, Tennessee, 37232, United States

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Arlington, Texas, 76015, United States

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Fort Worth, Texas, 76104, United States

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Fort Worth, Texas, 76105, United States

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Houston, Texas, 77004, United States

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Houston, Texas, 77099, United States

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San Antonio, Texas, 78229, United States

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Fairfax, Virginia, 22033, United States

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Edmonton, Alberta, T6G 2B7, Canada

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Greenfield Park, Quebec, J4V 2H1, Canada

Location

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 & Development
• 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 22, 2011
• First Posted: March 24, 2011
• Study Start: April 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 26, 2017
• Results First Posted: April 24, 2015

Record last verified: 2017-04

Locations

CA (2); US (38)