Iron maintenance during hemodialysis in pediatric patients

Phase 1

Conditions: Iron deficiency anaemia
MedDRA version: 20.0Level: PTClassification code 10022972Term: Iron deficiency anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2019-003140-71-PL

Lead Sponsor: Rockwell Medical, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

Patients must meet all of the following criteria to be eligible for inclusion in the study:
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 between 6 months and <18 years of age at screening.
3. Patient has chronic kidney disease receiving in-center hemodialysis or hemodiafiltration (HDF) at least twice weekly for at least 3 months 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 µg/L at screening.
8. Patient has a whole blood Hgb concentration of = 9.5 g/dL at. screening.
9. 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 who have reached menarche 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.
10. Patients who have experienced a previous adverse event with IV iron products are eligible to participate in this study if the agent that caused the event is not administered during the Baseline period.
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 is receiving intravenous or oral antibiotics or antifungals for any infectious process. (Prophylactic antibiotics administered on a regular basis are allowed. Patients may enter the study once the infection has cleared.)
3. Patient has evidence of an ongoing active inflammatory process (e.g., systemic lupus erythematosus, acute or chronic active hepatitis, etc.) requiring treatment.
4. Patient has been dosed in an investigational drug study within the 30 days prior to Baseline.
5. Administration of iron containing phosphate binder ferric citrate (Aurixia®) or sucroferric oxyhydide (Velphoro®) within 2 weeks prior to Baseline. (Patient is only eligible if iron based binders are stopped at least 2 weeks prior to Baseline).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety of Triferic administration via dialysate and IV in pediatric CKD-5HD patients;Secondary Objective: 1. To assess the ability of Triferic to maintain haemoglobin in pediatric CKD-5HD patients<br>2. To explore the effect of FPC treatment on ESA dose and ferritin concentration<br>3. To explore the effect of FPC treatment to reduce the need for IV iron supplementation for development of iron deficiency anaemia ;Primary end point(s): Incidence and severity of adverse events compared to Baseline.;Timepoint(s) of evaluation of this end point: Primary endpoint will be evaluated from Baseline to week 47.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Change from Baseline in Hgb concentration. <br>2. Change from Baseline in reticulocyte hemoglobin content (CHr). <br>3. Proportion of patients maintaining hemoglobin between 10.5 – 12.0 g/dL compared to Baseline. <br>4.Modeled Change from Baseline in reticulocyte hemoglobin content (CHr).<br>5. Proportion of patients with stable or a reduction in erythropoietin dose compared to Baseline.<br>6. Proportion of patients requiring intravenous iron compared to Baseline. <br>7. The change from Baseline in iron parameters. <br>8. Safety parameters. ;Timepoint(s) of evaluation of this end point: Secondary endpoints will be evaluated from base line to week 47.

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