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Trial record 70 of 385 for:    FERRIC CATION

Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 1)

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ClinicalTrials.gov Identifier: NCT01320202
Recruitment Status : Completed
First Posted : March 22, 2011
Results First Posted : April 28, 2015
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Rockwell Medical Technologies, Inc.

Tracking Information
First Submitted Date  ICMJE March 20, 2011
First Posted Date  ICMJE March 22, 2011
Results First Submitted Date  ICMJE March 20, 2015
Results First Posted Date  ICMJE April 28, 2015
Last Update Posted Date April 26, 2017
Study Start Date  ICMJE March 2011
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2015)
  • Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean [ Time Frame: Hgb measured weekly; up to 48 weeks from the 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 with standard error.
  • Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hgb [ Time Frame: Hgb measured weekly; up to 48 weeks from the 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).
Original Primary Outcome Measures  ICMJE
 (submitted: March 21, 2011)
Mean change from baseline in hemoglobin (Hgb) [ Time Frame: Hgb measured weekly; up to 22 1/2 months ]
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 double-blind 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.
Change History Complete list of historical versions of study NCT01320202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2015)
  • Mean Change in Serum Iron From Pre-dialysis to Post-dialysis. [ Time Frame: Up to 48 weeks from the 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.
  • Mean Change in TSAT (Transferrin) From Pre-dialysis to Post-dialysis. [ Time Frame: Up to 48 weeks from the 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.
  • Mean Change in Unsaturated Iron Binding Capacity (UIBC) From Pre- to Post-dialysis. [ Time Frame: Up to 48 weeks from the 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.
  • Red Blood Cell or Whole Blood Transfusion: Number of Patients Receiving Transfusion [ Time Frame: up to 48 weeks from the 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.
  • Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused [ Time Frame: up to 48 weeks from the 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.
  • Percentage of Change From Baseline to End-of-Treatment (EoT) for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and Pre-Dialysis Serum Iron Panel [ Time Frame: Up to 48 weeks from the 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).
  • Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Serum Iron, and Total Iron-Binding Capacity (TIBC) [ Time Frame: Up to 48 weeks from the 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.
  • Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr) [ Time Frame: Up to 48 weeks from the date of randomization ]
    The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr) will be quantified.
  • Change From Baseline to End-of-Treatment (EoT) in Ferritin [ Time Frame: Up to 48 weeks from the date of randomization ]
    The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Ferritin will be quantified.
  • Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin [ Time Frame: Up to 48 weeks from the date of randomization ]
    The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin will be quantified.
  • Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) [ Time Frame: Up to 48 weeks from the date of randomization ]
    The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) will be quantified.
  • Variability of Hemoglobin Concentration: Temporal Trend [ Time Frame: Hgb measured weekly; up to 48 weeks from the 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.
  • Variability of Hemoglobin Concentration: Residual Standard Deviation [ Time Frame: Hgb measured weekly; up to 48 weeks from the date of randomization ]
    The mean residual standard deviation of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2011)
  • Change from baseline mean hemoglobin (Hgb) during 4-week intervals [ Time Frame: Hgb measured weekly; up to 22 1/2 months ]
    Mean Hgb values and change from baseline during 4-week intervals (e.g., Weeks 1 through 4, 5 through 8, etc.).
  • Hgb values remained within the target [ Time Frame: Hgb measured weekly; up to 22 1/2 months ]
    The percent of observations per patient that Hgb values remained within the target range of ≥ 10.0 to ≤ 12.0 grams per deciliter (g/dL), below the target range (i.e., < 10 g/dL), and above the target range (i.e.., > 12.0 g/dL).
  • Decrease of ≥ 1.0 g/dL in Hgb from baseline sustained for ≥ 2 consecutive weeks [ Time Frame: Hgb measured weekly; up to 22 1/2 months ]
    The incidence of "treatment failures," where failure is defined as a decrease of ≥ 1.0 g/dL in Hgb from baseline sustained for ≥ 2 consecutive weeks.
  • Time to Hgb decrease of ≥ 1.0 grams per deciliter (g/dL) from baseline [ Time Frame: Hgb measured weekly; up to 22 1/2 months ]
    Time to meeting criteria for "treatment failures" where failure is defined as a decrease of ≥ 1.0 g/dL in Hgb from baseline sustained for ≥ 2 consecutive weeks.
  • The change and percent change from baseline in serum ferritin [ Time Frame: Serum ferritin measured every other week; up to 22 1/2 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients
Official Title  ICMJE 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 1) Study
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).
Detailed Description

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

Stage 1 (Run-In): 1-4 weeks 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Renal Failure Chronic Requiring Hemodialysis
Intervention  ICMJE
  • 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.
  • Device: Standard dialysate
    Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week.
Study Arms  ICMJE
  • Active Comparator: Soluble Ferric Pyrophosphate (SFP) in dialysate
    11 micrograms (µg) of iron / deciliter (dL) of dialysate.
    Intervention: Drug: Soluble Ferric Pyrophosphate (SFP)
  • Placebo Comparator: Standard Dialysate
    0 micrograms (µg) of iron / deciliter (dL) of dialysate.
    Intervention: Device: Standard dialysate
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 2, 2014)
305
Original Estimated Enrollment  ICMJE
 (submitted: March 21, 2011)
300
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01320202
Other Study ID Numbers  ICMJE RMTI-SFP-4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rockwell Medical Technologies, Inc.
Study Sponsor  ICMJE Rockwell Medical Technologies, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ray Pratt, MD Rockwell Medical
PRS Account Rockwell Medical Technologies, Inc.
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP