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Completed

NCT Number: NCT01503021

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

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.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Courtice, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Parent Study, Double Blinded, Crossover:

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  • Any previous exposure to SFP.
  • 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.
  • Non-tunneled vascular catheter for dialysis.
  • Scheduled for kidney transplant within the next 8 weeks.
  • Active infection requiring systemic antimicrobial or antifungal therapy within 2 weeks prior to screening, or during screening period prior to randomization.
  • Hospitalization within 1 month prior to screening (except for vascular access surgery).

Extension Study, Open Label, Single Active Arm:

Key Inclusion Criteria:

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

  • 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.
  • Non-tunneled vascular catheter for dialysis.
  • Scheduled for kidney transplant within 12 weeks after entry into extension phase.
  • Active infection requiring systemic antimicrobial or antifungal therapy within 2 weeks prior to dosing.
  • Pregnancy or intention to become pregnant during the study.

Treatment and study plan

SFP

Drug

Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate

Other names: Soluble ferric pyrophosphate

Placebo

Other

Dialysis with standard liquid bicarbonate concentrate without iron

Other names: Standard liquid bicarbonate concentrate

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Rockwell Medical Technologies, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 2, 2012
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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