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Trial record 46 of 386 for:    FERRIC CATION

Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in CKD Patients Receiving Chronic Hemodialysis

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: NCT01503021
Recruitment Status : Completed
First Posted : January 2, 2012
Results First Posted : April 21, 2015
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Rockwell Medical Technologies, Inc.

Tracking Information
First Submitted Date  ICMJE December 29, 2011
First Posted Date  ICMJE January 2, 2012
Results First Submitted Date  ICMJE April 3, 2015
Results First Posted Date  ICMJE April 21, 2015
Last Update Posted Date October 25, 2016
Study Start Date  ICMJE November 2011
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2015)
  • Incidence of Treatment-emergent Adverse Events [ Time Frame: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study ]
    Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention.
  • Incidence of Treatment-emergent Adverse Events of Intradialytic Hypotension [ Time Frame: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study ]
    Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met the protocol criteria for intradialytic hypotension. Intradialytic hypotension events were only to have been reported as adverse events if they exceeded the individual subject's baseline pattern of intradialytic hypotension.
  • Incidence of Related Suspected Hypersensitivity Reactions [ Time Frame: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study ]
    Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met protocol criteria for suspected hypersensitivity reactions.
Original Primary Outcome Measures  ICMJE
 (submitted: December 30, 2011)
Safety and tolerability of SFP in dialysate administered to a large number of representative adult chronic kidney disease on hemodialysis (CKD-HD) subjects. [ Time Frame: Up to 6 weeks ]
Safety assessments will be based on collection of adverse events (AEs), physical examinations, vital signs, laboratory parameters, and evaluation of dialysis parameters.
Change History Complete list of historical versions of study NCT01503021 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2015)
  • Incidence of Composite Cardiovascular Events [ Time Frame: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study ]
    Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for composite cardiovascular events were pre-specified in the statistical analysis plan for the study.
  • Incidence of Hemodialysis Vascular Access Thrombotic Events [ Time Frame: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study ]
    Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for hemodialysis vascular access thrombotic events were pre-specified in the statistical analysis plan for the study.
  • Incidence of Other Thrombotic Events [ Time Frame: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study ]
    Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for other thrombotic events were pre-specified in the statistical analysis plan for the study.
  • Incidence of Systemic/Serious Infections [ Time Frame: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study ]
    Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse events of systemic/serious infections were defined in the statistical analysis plan for the study to include infections for which the subject was administered at least 3 doses of an IV antibiotic, and infections for which the subject was hospitalized.
  • Incidence of Serious Adverse Events [ Time Frame: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study ]
    Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met seriousness criteria.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 21, 2015)
  • Serum Iron Change From Pre-dialysis to Post-dialysis at Week 2 [ Time Frame: Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study ]
    Serum iron was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.
  • Serum Iron Change From Pre-dialysis to Post-dialysis at Week 5 [ Time Frame: Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study ]
    Serum iron was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm.
  • Unsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 2 [ Time Frame: Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study ]
    Unsaturated iron-binding capacity was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.
  • Unsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 5 [ Time Frame: Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study ]
    Unsaturated iron-binding capacity was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm.
  • Transferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 2 [ Time Frame: Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study ]
    Transferrin saturation (based on TIBC derived from transferrin levels) was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.
  • Transferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 5 [ Time Frame: Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study ]
    Transferrin saturation (based on TIBC derived from transferrin levels) was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm.
  • Ferritin [ Time Frame: Baseline, up to 53 weeks for Extension Study ]
    The baseline and end of treatment predialysis ferritin levels were evaluated for the 52-week extension study to determine whether soluble ferric pyrophosphate increases iron stores.
  • Serum Iron [ Time Frame: Baseline, up to 53 weeks for Extension Study ]
    The baseline and end of treatment predialysis serum iron levels were evaluated for the 52-week extension study to determine the effect of soluble ferric pyrophosphate on serum iron.
  • Transferrin Saturation [ Time Frame: Baseline, up to 53 weeks for Extension Study ]
    The baseline and end of treatment predialysis transferrin saturation were evaluated for the 52-week extension study to confirm clearance of iron derived from soluble ferric pyrophosphate.
  • Incidence of Patients Meeting Hy's Law Criteria [ Time Frame: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study ]
    The peak alanine aminotransferase and the peak total bilirubin levels were evaluated per patient. Laboratory values for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Patients with alanine aminotransferase more than three times the upper limit of normal and also total bilirubin more than two times the upper limit of normal are counted.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in CKD Patients Receiving Chronic Hemodialysis
Official Title  ICMJE A Randomized, Double-Blinded, Placebo-Controlled, Crossover, Multicenter Phase III Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in Chronic Kidney Disease Patients Receiving Chronic Hemodialysis
Brief Summary

The purpose of the parent study is to assess the short-term safety and tolerability of soluble ferric pyrophosphate (SFP) in dialysate administered to a large number of representative adult chronic kidney disease patients on hemodialysis (CKD-HD).

The purpose of the extension study is to assess the long-term safety and tolerability of SFP.

Detailed Description

Parent Study: randomized, double-blinded, crossover, up to 6 weeks, 700 patients. Patients were randomized to receive SFP 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate or placebo (standard liquid bicarbonate concentrate) x 2 weeks, then a 1 week washout, then crossed over to the alternate treatment x 2 weeks.

Extension Study: open-label, single active arm, uncontrolled study, up to 53 weeks, 300 patients. Following completion of the RMTI-SFP-6 parent study, patients could enter the extension study, where they received SFP 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate for up to 52 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • End Stage Renal Disease
  • Chronic Kidney Disease
Intervention  ICMJE
  • Drug: SFP
    Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate
    Other Name: Soluble ferric pyrophosphate
  • Other: Placebo
    Dialysis with standard liquid bicarbonate concentrate without iron
    Other Name: Standard liquid bicarbonate concentrate
Study Arms  ICMJE
  • SFP/Placebo
    Soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks
    Interventions:
    • Drug: SFP
    • Other: Placebo
  • Placebo/SFP
    Standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks.
    Interventions:
    • Drug: SFP
    • Other: Placebo
Publications * Not Provided

*   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: April 3, 2014)
718
Original Estimated Enrollment  ICMJE
 (submitted: December 30, 2011)
600
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Parent Study, Double Blinded, Crossover:

Key Inclusion Criteria:

  1. Adult ≥ 18 years of age.
  2. Has chronic kidney disease (CKD) receiving maintenance hemodialysis (HD) (CKD-HD subjects) and regularly undergoing 2 or more dialysis sessions per week.
  3. Stable pre-dialysis Hgb ≥ 9.0 to ≤ 12.5 g/dL.
  4. Stable pre-dialysis TSAT ≥ 15% to ≤ 45%.
  5. Stable pre-dialysis ferritin ≥ 100 to ≤ 1200 µg/L (1200 ng/mL).

Key Exclusion Criteria:

  1. Any previous exposure to SFP.
  2. Therapy with intravenous, intramuscular or oral iron at any time between the first/screening visit and the randomization visit, or anticipated requirement for iron supplementation during the study period.
  3. Non-tunneled vascular catheter for dialysis.
  4. Scheduled for kidney transplant within the next 8 weeks.
  5. Active infection requiring systemic antimicrobial or antifungal therapy within 2 weeks prior to screening, or during screening period prior to randomization.
  6. Hospitalization within 1 month prior to screening (except for vascular access surgery).

Extension Study, Open Label, Single Active Arm:

Key Inclusion Criteria:

  1. Participated in Parent Study RMTI-SFP-6 and completed the follow-up/early term visit.
  2. Hemoglobin ≤12.0 g/dL at screening.
  3. TSAT ≤45% at screening. (Excursion of TSAT by ≤10% outside this range permitted only if all other inclusion/exclusion criteria are met).
  4. Serum ferritin ≤1000 µg/L at screening. (Excursion of ferritin by ≤10% outside this range permitted only if all other inclusion/exclusion criteria are met).

Key Exclusion Criteria:

  1. Had a serious adverse event attributable (i.e., probably, possibly, or definitely related) to study drug or had an adverse event attributable to study drug that necessitated premature withdrawal from the double-blind, placebo-controlled crossover phase of the parent study RMTI-SFP-6.
  2. Non-tunneled vascular catheter for dialysis.
  3. Scheduled for kidney transplant within 12 weeks after entry into extension phase.
  4. Active infection requiring systemic antimicrobial or antifungal therapy within 2 weeks prior to dosing.
  5. Pregnancy or intention to become pregnant during the study.
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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01503021
Other Study ID Numbers  ICMJE RMTI-SFP-6
Has Data Monitoring Committee No
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, Inc
PRS Account Rockwell Medical Technologies, Inc.
Verification Date September 2016

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