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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01503021
First received: December 29, 2011
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to assess the safety and tolerability and explore efficacy of Soluble Ferric Pyrophosphate (SFP) in dialysate administered to a large number of representative adult chronic kidney disease patients on hemodialysis (CKD-HD).


Condition Intervention Phase
End Stage Renal Disease
Chronic Kidney Disease
Drug: Soluble Ferric Pyrophosphate in liquid bicarbonate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 for the Parent Study and up to 53 weeks for Extension Study (Addendum) ] [ Designated as safety issue: No ]
    Safety assessments will be based on collection of adverse events (AEs), physical examinations, vital signs, laboratory parameters, and evaluation of dialysis parameters.


Other Outcome Measures:
  • Changes in hemoglobin and ESA dosing [ Time Frame: Up to 53 weeks ] [ Designated as safety issue: No ]
    Changes in hemoglobin and ESA dosing will be assessed (Addendum)


Enrollment: 718
Study Start Date: November 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SFP in liquid bicarbonate
Soluble Ferric Pyrophosphate at 2 µM (11 µg iron/dL of dialysate) in liquid bicarbonate
Drug: Soluble Ferric Pyrophosphate in liquid bicarbonate
Subjects will be randomized in a 1:1 ratio in a double-blinded fashion to one of two treatment sequences: initial treatment with SFP-containing dialysate (2 µM, 11 µg iron/dL of dialysate) or standard dialysate without SFP (placebo), then crossed over to the alternate treatment.
Other Name: SFP
Placebo Comparator: Conventional Liquid Bicarbonate
Control concentrate lacking SFP does not contain SFP (total iron = 0).
Drug: Soluble Ferric Pyrophosphate in liquid bicarbonate
Subjects will be randomized in a 1:1 ratio in a double-blinded fashion to one of two treatment sequences: initial treatment with SFP-containing dialysate (2 µM, 11 µg iron/dL of dialysate) or standard dialysate without SFP (placebo), then crossed over to the alternate treatment.
Other Name: SFP

Detailed Description:

Parent Study: A Randomized, Double Blinded, Crossover Study, up to 6 weeks, 900 patients.

Extension Study (Addendum): Open Label, Uncontrolled Study, up to 53 weeks, 300 patients.

  Eligibility

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

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).

Extention Study (Addendum), Open Label:

Key Inclusion Criteria:

  1. Participated in 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01503021

  Show 31 Study Locations
Sponsors and Collaborators
Rockwell Medical Technologies, Inc.
Investigators
Study Director: Ajay Gupta, MD Rockwell Medical Technologies, Inc.
  More Information

No publications provided

Responsible Party: Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01503021     History of Changes
Other Study ID Numbers: RMTI-SFP-6
Study First Received: December 29, 2011
Last Updated: April 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Rockwell Medical Technologies, Inc.:
Soluble Ferric Pyrophosphate in Dialysate
Chronic Kidney Disease
Chronic hemodialysis

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

ClinicalTrials.gov processed this record on April 22, 2014