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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01322347
First received: March 22, 2011
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention Phase
Renal Failure Chronic Requiring Hemodialysis
Drug: Soluble Ferric Pyrophosphate (SFP)
Device: Standard dialysate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Phase III Study of Dialysate Containing Soluble Ferric Pyrophosphate (SFP) in Chronic Kidney Disease Patients Receiving Hemodialysis: The Continuous Replacement Using Iron Soluble Equivalents (CRUISE 2) Study

Resource links provided by NLM:


Further study details as provided by Rockwell Medical Technologies, Inc.:

Primary Outcome Measures:
  • Mean change from baseline in hemoglobin (Hgb) [ Time Frame: Hgb measured weekly; up to 20 months ] [ Designated as safety issue: No ]
    Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last 8 weeks of the 12-month randomized treatment period, or 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.


Secondary Outcome Measures:
  • Decrease in Hgb to < 9 g/dL sustained for ≥ 2 consecutive weeks. [ Time Frame: Hgb measured weekly; up to 20 months ] [ Designated as safety issue: No ]
    The incidence of "treatment failures," defined as decrease in Hgb to < 9 g/dL sustained for ≥ 2 consecutive weeks.

  • Decrease in Hgb of ≥ 1.0 g/dL from baseline sustained for ≥ 2 consecutive weeks. [ Time Frame: Hgb measured weekly; up to 20 months ] [ Designated as safety issue: No ]
    The incidence of a decrease in Hgb of ≥ 1.0 g/dL from baseline sustained for ≥ 2 consecutive weeks.

  • Decrease in ferritin to < 100 µg/L sustained for ≥ 2 consecutive weeks. [ Time Frame: Serum ferritin measured every other week; up to 20 months ] [ Designated as safety issue: No ]
    The incidence of decrease in ferritin to < 100 µg/L sustained for ≥ 2 consecutive weeks.

  • Hgb concentration in the range of ≥ 9.5 to ≤ 11.5 g/dL. [ Time Frame: Hgb measured weekly; up to 20 months ] [ Designated as safety issue: No ]
    The percent of patients maintaining Hgb concentration in the range of ≥ 9.5 to ≤ 11.5 g/dL for ≥80% of time on study.

  • TSAT in the range of 20-50%. [ Time Frame: TSAT measured every other week; up to 20 months ] [ Designated as safety issue: No ]
    The percent of patients maintaining TSAT in the range of TSAT 20-50% for ≥80% of time on study.

  • Ferritin in the range of 200-800 µg/dL. [ Time Frame: Serum ferritin measured every other week; up to 20 months ] [ Designated as safety issue: No ]
    The percent of patients maintaining ferritin in the range of ferritin 200-800 µg/dL for ≥80% of time on study.

  • Variability in Hgb [ Time Frame: Hgb measured weekly; up to 20 months ] [ Designated as safety issue: No ]
  • Red blood cell or whole blood transfusion, and IV iron administration. [ Time Frame: up to 20 months ] [ Designated as safety issue: No ]
    The incidence of requiring red blood cell or whole blood transfusion, and IV iron administration (in aggregate and separately).


Enrollment: 294
Study Start Date: April 2011
Study Completion Date: February 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Soluble Ferric Pyrophosphate (SFP) in dialysate
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Drug: Soluble Ferric Pyrophosphate (SFP)
Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months.
Placebo Comparator: Standard Dialysate
0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Device: Standard dialysate
Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week.

Detailed Description:

Screening: 2-3 weeks prior to enrollment in Stage 1.

Stage 1 (Run-In): 1-4weeks depending on qualification for Stage 2.

Stage 2 (Randomized Blinded Treatment): 12 months unless withdrawn prematurely.

Stage 3 (Open-Label Treatment): The duration of Stage 2 plus Stage 3 is intended to be 18 months regardless of treatment assignment in Stage 2.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Stage 1:

Main Inclusion Criteria:

  • 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.

Main Exclusion Criteria:

  • 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:

Main Inclusion Criteria:

  • 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.

Main Exclusion Criteria:

  • 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 any amount of IV iron during the 4 weeks prior to randomization.
  • If being administered an (Erythropoietin Stimulating Agent) ESA, change in dose over the 6 weeks immediately prior to randomization.
  • Serum albumin < 3.0 g/dL any time over the 8 weeks prior to randomization.
  • RBC or whole blood transfusion during Stage 1.

Stage 3:

Main Inclusion Criteria:

  • Patient randomized in Stage 2 who has completed the full duration of Stage 2 and less than 4 weeks have elapsed since completion of Stage 2, OR
  • Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for protocol-defined Protocol-Mandated Change in Anemia Management and less than 4 weeks have elapsed since withdrawal from Stage 2, OR
  • Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for Hgb >11.5 g/dL over ≥ 1 week confirmed by ≥ 2 consecutive measurements AND an associated increase in Hgb by ≥ 1 g/dL over 4 weeks.

Main Exclusion Criteria:

  • Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for any reason other than as noted in inclusion criteria above.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322347

  Show 40 Study Locations
Sponsors and Collaborators
Rockwell Medical Technologies, Inc.
Investigators
Study Director: Ajay Gupta, MD Rockwell Medical
  More Information

No publications provided

Responsible Party: Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01322347     History of Changes
Other Study ID Numbers: RMTI-SFP-5
Study First Received: March 22, 2011
Last Updated: April 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Rockwell Medical Technologies, Inc.:
End Stage Renal Disease
Hemodialysis
SFP
Hemodialysis-dependent chronic renal failure

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Iron
Dialysis Solutions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Pharmaceutical Solutions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014