Clinical trial NCT03303144: Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients
Official title: Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: End Stage Renal Disease
Keywords: Pharmacokinetics
Equivalence
Lead sponsor: Rockwell Medical Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-05
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pharmacokinetics (PK) of Triferic Iron Administered Via Hemodialysate in Adult CKD-5HD Patients: Cmax.
timeFrame: 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 12 hours
measure: Pharmacokinetics (PK) of Triferic Iron Administered IV in Adult CKD-5HD Patients:Cmax
timeFrame: 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 12 hours
measure: Pharmacokinetics (PK) of Triferic Iron Administered IV in Adult CKD-5HD Patients: AUC(0-end).
timeFrame: 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 12 hours
Secondary outcomes:
measure: Safety Endpoint: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Incidence of Treatment Emergent Serious Adverse Events
timeFrame: 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
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
Study officials:
affiliation: Orlando Clinical Research Center
name: Thomas Marbury
role: PRINCIPAL_INVESTIGATOR
References: