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

NCT ID: NCT03303144

Last Updated: 2020-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2017-12-28

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

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.

Conditions

End Stage Renal Disease

Keywords

Pharmacokinetics; Equivalence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Triferic

Intervention Type: DRUG

ferric pyrophosphate citrate

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)

Group Type: EXPERIMENTAL

Triferic

Intervention Type: DRUG

ferric pyrophosphate citrate

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)

Group Type: EXPERIMENTAL

Triferic

Intervention Type: DRUG

ferric pyrophosphate citrate

Interventions

Triferic

ferric pyrophosphate citrate

Intervention Type: DRUG

Other Intervention Names

ferric pyrophosphate citrate; FPC

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rockwell Medical Technologies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Marbury

Role: PRINCIPAL_INVESTIGATOR

Orlando Clinical Research Center

Locations

Orlando Clinical Research Center

Orlando, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RMFPC-20

Identifier Type: -

Identifier Source: org_study_id