- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03303144
Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients
October 21, 2020 updated by: Rockwell Medical Technologies, Inc.
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
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Orlando, Florida, United States, 32809
- Orlando Clinical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- The patient must be 18-80 years of age inclusive at the time of consent.
- 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.
- The patient must have a Screening ferritin level of ≥100µg/L.
- The patient must have a Screening transferrin saturation (TSAT) of 15-45%, inclusive.
- The patient must have a Screening hemoglobin (Hgb) concentration ≥9.0 g/dL.
- The patient must be undergoing hemodialysis at least 3x/week.
- 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.
- 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.
- The patient's vascular access for dialysis that will be used during the study must have stable function in the judgment of the Investigator.
- 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.
- 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:
- The patient has had an RBC or whole blood transfusion within 4 weeks prior to Screening.
- The patient requires a continuous infusion of heparin during standard hemodialysis.
- 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.).
- The patient has known active bleeding from any site other than AV fistula or graft (e.g., gastrointestinal, hemorrhoidal, nasal, pulmonary, etc.).
- 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.)
- The patient is scheduled to have a surgical procedure during the study.
- 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.
- The patient has a history of noncompliance with the dialysis regimen in the opinion of the Investigator.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
ferric pyrophosphate citrate
Other Names:
|
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)
|
ferric pyrophosphate citrate
Other Names:
|
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)
|
ferric pyrophosphate citrate
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics (PK) of Triferic Iron Administered Via Hemodialysate in Adult CKD-5HD Patients: Cmax.
Time Frame: 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 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.
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1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 12 hours
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Pharmacokinetics (PK) of Triferic Iron Administered IV in Adult CKD-5HD Patients:Cmax
Time Frame: 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 12 hours
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1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 12 hours
|
|
Pharmacokinetics (PK) of Triferic Iron Administered IV in Adult CKD-5HD Patients: AUC(0-end).
Time Frame: 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 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.
|
1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 12 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety Endpoint: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Incidence of Treatment Emergent Serious Adverse Events
Time Frame: From the start of the HD #1 through the end of study participation or 7 days after the last dose of Triferic, whichever is later, assessed up to 2 months
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Safety will be documented by recording the incidence of treatment-emergent serious adverse events (TESAEs).The number of patients that experienced treatment emergent serious adverse events will be quantified.
Please see the adverse event table for specifics.
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From the start of the HD #1 through the end of study participation or 7 days after the last dose of Triferic, whichever is later, assessed up to 2 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thomas Marbury, Orlando Clinical Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 1, 2017
Primary Completion (ACTUAL)
December 28, 2017
Study Completion (ACTUAL)
December 28, 2017
Study Registration Dates
First Submitted
September 28, 2017
First Submitted That Met QC Criteria
October 2, 2017
First Posted (ACTUAL)
October 5, 2017
Study Record Updates
Last Update Posted (ACTUAL)
November 16, 2020
Last Update Submitted That Met QC Criteria
October 21, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RMFPC-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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