Trial Search Results
Triferic Pediatric Pharmacokinetic Protocol
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.
Stanford is currently not accepting patients for this trial.
Rockwell Medical Technologies, Inc.
- Drug: Triferic
Phase 1/Phase 2
A patient will be eligible for inclusion in the study only if all of the following criteria
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
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.
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
6. Administration of IV or oral iron supplements within 2 weeks prior to Baseline
Ages Eligible for Study
N/A - 17 Years
Genders Eligible for Study