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Triferic Pediatric Pharmacokinetic Protocol

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ClinicalTrials.gov Identifier: NCT02595437
Recruitment Status : Completed
First Posted : November 3, 2015
Results First Posted : October 25, 2018
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Rockwell Medical Technologies, Inc.

Brief Summary:
The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is an open-label, two-period sequential dosing study.

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

Detailed Description:

This is a Phase 1/2, open-label, 2-period, single-dose study assessing the safety and pharmacokinetics (PK) of Triferic (ferric pyrophosphate citrate, or FPC) administered via dialysate and IV to pediatric patients (< 18 years of age) receiving chronic hemodialysis (CKD-5HD).

Total participation in the study is approximately three weeks and is comprised of a screening visit, two dosing (PK) visits, and a follow-up visit.

Each patient will receive a single dose of Triferic administered IV into the venous blood return line over the duration of the dialysis. At the next scheduled dialysis session each patient will receive a single dose of Triferic administered via dialysate during a single hemodialysis session.

Blood samples will be obtained at various times to analyze for serum iron parameters and for safety.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Via Dialysate and IV to Pediatric Patients on Chronic Hemodialysis
Study Start Date : November 1, 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Triferic via IV and Hemodialysate
On study Day 1, patients will receive IV Triferic iron 0.07 mg/kg diluted in an appropriate amount of D5W administered as a 100 mL infusion into the venous return port of the blood lines during the time the patient is receiving dialysis.The rate of administration will be calculated as such that the entire amount will be administered over the course of the dialysis treatment. On study Day 3, 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 via the hemodialysate over the course of the dialysis treatment.
Drug: Triferic
Other Names:
  • ferric pyrophosphate citrate
  • FPC




Primary Outcome Measures :
  1. Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: Cmax. [ Time Frame: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hrs ]
    The PK will be done by assessing the mean absolute and baseline-corrected Cmax of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute Cmax includes the concentration of iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.

  2. Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: AUC(Last). [ Time Frame: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours ]
    The PK will be done by assessing the mean absolute and baseline-corrected AUC(last) of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute AUC(last) includes iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected AUC(last) factors out the iron present in the serum prior to dosing and includes the administered iron only.

  3. Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: AUC(0-end). [ Time Frame: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours ]
    The PK will be done by assessing the mean absolute and baseline-corrected AUC(0-end) of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute AUC (0-end) includes iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected AUC (0-end) factors out the iron present in the serum prior to dosing and includes the administered iron only.


Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: Cmax. [ Time Frame: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours ]
    The PK will be done by assessing the mean absolute and baseline-corrected Cmax of total iron. The absolute Cmax includes the concentration of iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.

  2. Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: AUC(Last). [ Time Frame: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours ]
    The PK will be done by assessing the mean absolute and baseline-corrected AUC(last) of total iron. The absolute AUC (last) includes the iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.

  3. Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: AUC(0-end). [ Time Frame: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours ]
    The PK will be done by assessing the mean absolute and baseline-corrected AUC(0-end) of total iron. The absolute AUC (0-end) includes the of iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.


Other Outcome Measures:
  1. Treatment-emergent Adverse Events (TEAEs) [ Time Frame: 1.5 weeks ]
    The incidence of treatment-emergent AEs (TEAEs) and treatment-emergent serious AEs (TESAEs) will be grouped by body system. Adverse events were recorded from study Day 1 through the following up visit (approximately 1.5 weeks).



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A patient will be eligible for inclusion in the study only if all of the following criteria are met:

  1. Parents/legal guardians of the patient have the ability to understand the requirements of the study and have demonstrated a willingness to have their child comply with all study procedures by signing an institutional review board-approved informed consent form. Where applicable, assent of the patient has also been obtained for all study procedures prior to any study-related activities.
  2. Patient is <18 years of age at screening.
  3. Patient has chronic kidney disease receiving in-center hemodialysis at least twice weekly for at least 1 month prior to screening.
  4. Patient is receiving adequate hemodialysis as assessed by the investigator and based on a single pool Kt/V measurement >1.2.
  5. Patient has a vascular access (tunneled catheter, AV fistula or AV graft) suitable to support blood flows for hemodialysis treatment.
  6. Patient has a body mass of 11 lbs (5 kg).
  7. Patient is iron-replete as measured by a TSAT 20% and a ferritin >100 micrograms/L at screening.
  8. Patient has a whole blood Hgb concentration of 10.0 g/dL at screening.
  9. If patient is receiving ESA, the dose has been stable (unchanged) for at least 3 weeks prior to Baseline admission.
  10. Patient has appropriate laboratory values for their disease state at screening (per investigator judgment).
  11. Patient has no significant abnormal findings on physical examination that would preclude participation in the study.
  12. If the patient is female, she must be pre-pubertal, have had documented surgical sterilization prior to Baseline admission, or be practicing adequate birth control. All female patients 9 years of age and older, and also any who have reached menarche before age 9 years, must have a negative serum pregnancy test during screening. It is the investigator's responsibility to determine whether the patient has adequate birth control for study participation.

Exclusion Criteria:

A patient will not be eligible for inclusion in the study if any of the following criteria apply:

  1. Patient is positive for human immunodeficiency virus (HIV) or hepatitis B by history.
  2. Patient has an acute illness within 1 week of Baseline admission (patient may be screened again 2 weeks post resolution of the acute illness).
  3. Patient is receiving intravenous or oral antibiotics or antifungals for any infectious process. Prophylactic antibiotics administered on a regular basis are allowed.
  4. Patient has evidence of an ongoing active inflammatory process (e.g., systemic lupus erythematosus, acute or chronic active hepatitis, etc.).
  5. Patient has participated in an investigational drug study within the 30 days prior to Baseline admission.
  6. Administration of IV or oral iron supplements within 2 weeks prior to Baseline admission.

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): NCT02595437


Locations
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United States, Alabama
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
United States, California
Loma Linda University Hospital
Loma Linda, California, United States, 92354
Lucile Packard Childrens Hospital
Stanford, California, United States, 94305
United States, Delaware
Nemours/A. I. DuPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, Florida
Joe DiMagggio Children's Hospital/Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Jackson Memorial Hospital
Miami, Florida, United States, 33136
United States, Missouri
Childrens Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, Ohio
Cincinnati Children's Hospital and Medical Center
Cincinnati, Ohio, United States, 45229
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Rockwell Medical Technologies, Inc.
Investigators
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Study Director: Raymond D Pratt, MD FACP Rockwell Medical, Inc
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Responsible Party: Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT02595437    
Other Study ID Numbers: RMFPC-11
First Posted: November 3, 2015    Key Record Dates
Results First Posted: October 25, 2018
Last Update Posted: October 25, 2018
Last Verified: September 2018
Keywords provided by Rockwell Medical Technologies, Inc.:
dialysis
pediatric
chronic kidney disease
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency