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Trial record 90 of 385 for:    FERRIC CATION

Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients

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ClinicalTrials.gov Identifier: NCT03303144
Recruitment Status : Completed
First Posted : October 5, 2017
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Rockwell Medical Technologies, Inc.

Brief Summary:
The main purpose is to establish the equivalence of Triferic iron administered via dialysate into the arterial blood line and into the venous blood line

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Drug: Triferic Phase 1 Phase 2

Detailed Description:
An open-label, four period, randomized, crossover study of Triferic iron administered via hemodialysis compared to Triferic administered intravenously pre- and post- hemodialyzer.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: Triferic via Hemodialysate
Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic over 4 hrs at one hemodialysis session.
Drug: Triferic
ferric pyrophosphate citrate
Other Names:
  • ferric pyrophosphate citrate
  • FPC

Experimental: Triferic via IV infusion( pre-dialyzer)
Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via arterial blood line (pre-dialyzer)
Drug: Triferic
ferric pyrophosphate citrate
Other Names:
  • ferric pyrophosphate citrate
  • FPC

Experimental: Triferic via IV infusion (post-dialyzer)
Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via venous blood line (post-dialyzer)
Drug: Triferic
ferric pyrophosphate citrate
Other Names:
  • ferric pyrophosphate citrate
  • FPC




Primary Outcome Measures :
  1. Pharmacokinetics (PK) of Triferic Iron Administered Via Hemodialysate in Adult CKD-5HD Patients: Cmax. [ Time Frame: 12 hours ]
    The PK will be done by assessing the mean Cmax of total serum iron from Triferic administered via hemodialysate, compared to Triferic administered at a fixed IV dose of 6.6 mg iron/kg during a single dialysis session.

  2. Pharmacokinetics (PK) of Triferic Iron Administered IV in Adult CKD-5HD Patients: AUC(0-t). [ Time Frame: 12 hours ]
    The PK will be done by assessing the mean AUC(0-t) of total serum iron from Triferic administered via hemodialysate, compared to Triferic administered at a fixed IV dose of 6.5 mg iron/kg during a single dialysis session.

  3. Pharmacokinetics (PK) of Triferic Iron Administered IV in Adult CKD-5HD Patients: AUC(0-end). [ Time Frame: 12 hours ]
    The PK will be done by assessing the mean AUC(0-end) of total serum iron from Triferic administered via hemodialysate, compared to Triferic administered at a fixed IV dose of 6.5 mg iron/kg during a single dialysis session.


Secondary Outcome Measures :
  1. Safety Endpoint: Treatment-emergent Adverse Events (TEAEs) [ Time Frame: 7 days ]
    Safety will be documented by recording the incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient must be able to provide informed consent and have personally signed and dated the written informed consent document before completing any study-related procedures.
  2. The patient must be 18-80 years of age inclusive at the time of consent.
  3. The patient must have been undergoing chronic hemodialysis for chronic kidney disease for at least 3 months, and be expected to remain on hemodialysis and be able to complete the study.
  4. The patient must have a Screening ferritin level of ≥100µg/L.
  5. The patient must have a Screening transferrin saturation (TSAT) of 15-45%, inclusive.
  6. The patient must have a Screening hemoglobin (Hgb) concentration ≥9.0 g/dL.
  7. The patient must be undergoing hemodialysis at least 3x/week.
  8. The patient must have at least a minimally adequate measured dialysis dose defined as single-pool Kt/V (dialyzer clearance of urea multiplied by dialysis time, divided by patient's total body water) ≥1.2, or KIDt/V (online dialyzer clearance measured using ionic dialysance multiplied by dialysis time, divided by patient's total body water) ≥1.2 measured within the 90 days prior to HD #1.
  9. Patient is receiving, or can receive anticoagulation for dialysis by a single dose of unfractionated heparin or low molecular weight heparin pre-dialysis; or by intermittent IV heparin bolus.
  10. The patient's vascular access for dialysis that will be used during the study must have stable function in the judgment of the Investigator.
  11. The patient must agree to discontinue all iron preparations (oral and IV) for 14 days prior to the start of HD#1 and throughout the study.
  12. Female patients must not be pregnant or breastfeeding. They must have been amenorrheic for the past year or be surgically sterile or agree to not become pregnant by continuous use of an effective birth control method acceptable to the Investigator for the duration of their participation in the study.

Exclusion Criteria:

  1. The patient has had an RBC or whole blood transfusion within 4 weeks prior to Screening.
  2. The patient requires a continuous infusion of heparin during standard hemodialysis.
  3. The patient has had administration of IV or oral iron supplements (including multivitamins with iron or iron based phosphate binders) within 14 days prior to the start of HD #1. (The patient may subsequently become eligible if additional time elapses and all other eligibility criteria are met.).
  4. The patient has known active bleeding from any site other than AV fistula or graft (e.g., gastrointestinal, hemorrhoidal, nasal, pulmonary, etc.).
  5. The patient has a living kidney donor identified or living-donor kidney transplant scheduled to occur during study participation. (Note: Patients awaiting deceased-donor transplant need not be excluded.)
  6. The patient is scheduled to have a surgical procedure during the study.
  7. The patient has had a hospitalization within the 4 weeks prior to Screening (except for vascular access surgery) that, in the opinion of the Investigator, confers a significant risk of hospitalization during the course of the study.
  8. The patient has a history of noncompliance with the dialysis regimen in the opinion of the Investigator.
  9. The patient has a known ongoing active inflammatory disorder (other than CKD), such as systemic lupus erythematosus, rheumatoid arthritis, or other collagen-vascular disease, that currently requires systemic anti-inflammatory or immunomodulatory therapy.

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): NCT03303144


Locations
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United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Rockwell Medical Technologies, Inc.
Investigators
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Principal Investigator: Thomas Marbury Orlando Clinical Research Center

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Responsible Party: Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT03303144     History of Changes
Other Study ID Numbers: RMFPC-20
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rockwell Medical Technologies, Inc.:
Pharmacokinetics
Equivalence
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Iron
Citric Acid
Sodium Citrate
Hemodialysis Solutions
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Dialysis Solutions
Pharmaceutical Solutions