Triferic Pediatric Pharmacokinetic Protocol

NCT02595437 | Completed Phase 1 Results

• 1 other identifier: RMFPC-11
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 9

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.

Conditions

End Stage Renal Disease

Keywords

dialysis; pediatric; chronic kidney disease

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: Cmax.

  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.

  0, 1, 2, 4, 4.5, 5, 6, 8, 10 hrs

• Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: AUC(Last).

  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.

  0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours

• Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: AUC(0-end).

  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.

  0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours

Secondary Outcomes (3)

• Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: Cmax.

  0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours

• Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: AUC(Last).

  0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours

• Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: AUC(0-end).

  0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours

Other Outcomes (1)

• Treatment-emergent Adverse Events (TEAEs)

  1.5 weeks

Study Arms (1)

Triferic via IV and Hemodialysate

EXPERIMENTAL

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

Interventions

Triferic DRUG

Also known as: ferric pyrophosphate citrate, FPC

Triferic via IV and Hemodialysate

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Patient is \<18 years of age at screening.
• Patient has chronic kidney disease receiving in-center hemodialysis at least twice weekly for at least 1 month prior to screening.
• Patient is receiving adequate hemodialysis as assessed by the investigator and based on a single pool Kt/V measurement \>1.2.
• Patient has a vascular access (tunneled catheter, AV fistula or AV graft) suitable to support blood flows for hemodialysis treatment.
• Patient has a body mass of 11 lbs (5 kg).
• Patient is iron-replete as measured by a TSAT 20% and a ferritin \>100 micrograms/L at screening.
• Patient has a whole blood Hgb concentration of 10.0 g/dL at screening.
• If patient is receiving ESA, the dose has been stable (unchanged) for at least 3 weeks prior to Baseline admission.
• Patient has appropriate laboratory values for their disease state at screening (per investigator judgment).
• Patient has no significant abnormal findings on physical examination that would preclude participation in the study.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rockwell Medical Technologies, Inc.: lead

Study Sites (9)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

Loma Linda University Hospital

Loma Linda, California, 92354, United States

Location

Lucile Packard Childrens Hospital

Stanford, California, 94305, United States

Location

Nemours/A. I. DuPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Joe DiMagggio Children's Hospital/Memorial Regional Hospital

Hollywood, Florida, 33021, United States

Location

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Childrens Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Cincinnati Children's Hospital and Medical Center

Cincinnati, Ohio, 45229, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic

Interventions

ferric pyrophosphate; spleen fibrinolytic proteinase (human)

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Rockwell Medical, Inc

sgrimberg@rockwellmed.com

248-960-9009

Study Officials

• Raymond D Pratt, MD FACP

  Rockwell Medical, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: November 3, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: October 25, 2018
• Results First Posted: October 25, 2018

Record last verified: 2018-09

Locations

US (9)