Triferic Pediatric Pharmacokinetic Protocol

Not Recruiting

Trial ID: NCT02595437


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.

Official Title

Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Via Dialysate and IV to Pediatric Patients on Chronic Hemodialysis

Stanford Investigator(s)


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

   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

   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


drug: Triferic

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Survana Bhamre