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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01322347
Recruitment Status : Completed
First Posted : March 24, 2011
Results First Posted : April 24, 2015
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Rockwell Medical Technologies, Inc.

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).

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

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Stage 2 (Randomized Blinded Treatment): 12 months unless withdrawn prematurely.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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : April 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean [ Time Frame: Hgb measured weekly; up to 48 weeks from date of randomization ]
    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.

  2. Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hemoglobin [ Time Frame: Hgb measured weekly; up to 48 weeks from date of randomization ]
    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).


Secondary Outcome Measures :
  1. Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis [ Time Frame: Up to 48 weeks from date of randomization ]
    The mean difference between the pre-dialysis and post-dialysis serum iron was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.

  2. Mean Change in Transferrin Saturation From Pre-Dialysis to Post-Dialysis [ Time Frame: Up to 48 weeks from date of randomization ]
    The mean difference between the pre-dialysis and post-dialysis TSAT (transferrin) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.

  3. Mean Change in Unsaturated Iron-Binding Capacity (UIBC) From Pre-Dialysis to Post-Dialysis [ Time Frame: Up to 48 weeks from date of randomization ]
    The mean difference between the pre-dialysis and post-dialysis unsaturated iron binding capacity (UIBC) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.

  4. Red Blood Cell or Whole Blood Transfusion: Number of Patients Who Received a Transfusion [ Time Frame: Up to 48 weeks from date of randomization ]
    The number of patients requiring red blood cell or whole blood transfusion while in the randomized treatment stage (Stage 2). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.

  5. Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused [ Time Frame: Up to 48 weeks from date of randomization ]
    The total number of units of red blood cells or whole blood that were received by patients while in the randomized treatment stage (Stage 2). This number is the total number of units received across all randomized patients in each treatment group (it is not the average number of units received per patient). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.

  6. Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel [ Time Frame: up to 48 weeks from date of randomization ]
    A comparison of the lab values at the end-of-treatment (EoT) to baseline was performed, and the percentage of change from baseline was calculated for the following lab parameters: reticulocyte hemoglobin content (CHr), Ferritin, pre-dialysis unbound iron-binding capacity (UIBC), pre-dialysis serum iron, pre-dialysis transferrin, pre-dialysis total iron-binding capacity TIBC), and transferrin saturation (TSAT).

  7. Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) [ Time Frame: Up to 48 weeks from date of randomization ]
    The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) will be quantified.

  8. Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr) [ Time Frame: Up to 48 weeks from date of randomization ]
    The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr)

  9. Change From Baseline to End-of-Treatment (EoT) in Ferritin [ Time Frame: Up to 48 weeks from date of randomization ]
    The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Ferritin

  10. Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin [ Time Frame: Up to 48 weeks from date of randomization ]
    The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin

  11. Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) [ Time Frame: Up to 48 weeks from date of randomization ]
    The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)

  12. Variability of Hemoglobin Concentration: Temporal Trend [ Time Frame: up to 48 weeks from date of randomization ]
    The mean temporal trend of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.

  13. Variability of Hemoglobin Concentration: Residual Standard Deviation [ Time Frame: up to 48 weeks from date of randomization ]
    The mean residual standard deviation of the hemoglobin concentration changes, as measured weekly from baseline until the end of participation in Stage 2.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322347


Locations
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United States, Arkansas
Investigator
Paragould, Arkansas, United States, 72450
Investigator
Pine Bluff, Arkansas, United States, 71603
United States, California
Investigator
Alhambra, California, United States, 91801
Investigator
Beverly Hills, California, United States, 90211
Investigator
Glendale, California, United States, 91204
Investigator
La Mesa, California, United States, 91942
Investigator
Long Beach, California, United States, 90807
Investigator
Lynwood, California, United States, 90262
Investigator
Paramount, California, United States, 90723
Investigator
Whittier, California, United States, 90603
United States, Florida
Investigator
Pembroke Pines, Florida, United States, 33025
United States, Georgia
Investigator
Augusta, Georgia, United States, 30901
Investigator
Macon, Georgia, United States, 31217
United States, Idaho
Investigator
Meridian, Idaho, United States, 83642
United States, Illinois
Investigator
Hines, Illinois, United States, 60141
United States, Maryland
Investigator
Rockville, Maryland, United States, 20850
United States, Michigan
Investigator
Detroit, Michigan, United States, 48236
Investigator
Pontiac, Michigan, United States, 48341
Investigator
Southfield, Michigan, United States, 48034
United States, New Jersey
Investigator
Eatontown, New Jersey, United States, 07724
United States, New York
Investigator
Brooklyn, New York, United States, 11212
Investigator
Fresh Meadows, New York, United States, 11365
Investigator
Great Neck, New York, United States, 11021
Investigator
Orchard Park, New York, United States, 14127
Investigator
The Bronx, New York, United States, 10461
United States, Oklahoma
Investigator
Bethany, Oklahoma, United States, 73008
United States, Pennsylvania
Investigator
Bethlehem, Pennsylvania, United States, 18017
Investigator
Philadelphia, Pennsylvania, United States, 19106
Investigator
Philadelphia, Pennsylvania, United States, 19144
United States, Tennessee
Investigator
Nashville, Tennessee, United States, 37205
Investigator
Nashville, Tennessee, United States, 37232
United States, Texas
Investigator
Arlington, Texas, United States, 76015
Investigator
Fort Worth, Texas, United States, 76104
Investigator
Fort Worth, Texas, United States, 76105
Investigator
Houston, Texas, United States, 77004
Investigator
Houston, Texas, United States, 77099
Investigator
San Antonio, Texas, United States, 78229
United States, Virginia
Investigator
Fairfax, Virginia, United States, 22033
Canada, Alberta
Investogator
Edmonton, Alberta, Canada, T6G 2B7
Canada, Quebec
Investigator
Greenfield Park, Quebec, Canada, J4V 2H1
Sponsors and Collaborators
Rockwell Medical Technologies, Inc.
Investigators
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Study Director: Ray Pratt, MD Rockwell Medical
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01322347    
Other Study ID Numbers: RMTI-SFP-5
First Posted: March 24, 2011    Key Record Dates
Results First Posted: April 24, 2015
Last Update Posted: April 26, 2017
Last Verified: April 2017
Keywords provided by Rockwell Medical Technologies, Inc.:
End Stage Renal Disease
Hemodialysis
SFP
Hemodialysis-dependent chronic renal failure
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Dialysis Solutions
Pharmaceutical Solutions