Iron Sucrose in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron Sucrose Injection) in NDD-CKD pediatric patients.

Official Title
-----------------
Single-Dose Pharmacokinetics of Venofer (Iron Sucrose Injection) in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients Receiving or Not Receiving Erythropoiesis Stimulating Agents (ESA's)

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Venofer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > or = 12 to < or = 16 years Parent and/or legal guardian able to give informed consent Subject able to give written assent for participating in the study NDD-CKD defined as: kidney damage for 3 months or longer, or GFR < 60 for 3 months or longer Hemoglobin indicative of anemia Ferritin indicative of iron deficiency anemia If appropriate, subject must be willing to use an accepted form of birth control from time of screening through the follow-up period Exclusion Criteria: Known history of hypersensitivity to any component of Venofer Parenteral iron within 14 days of the screening visit Dialysis dependent-CKD Chronic or serious active infection Pregnancy or lactation Subjects with causes of iron deficiency anemia other than CKD Blood transfusion within the last month or anticipated during the study Body weight < 55 pounds Received an investigational drug within 30 days before screening

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacokinetic Population<br>All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose. | Drug: Venofer<br>* Single dose of 7mg intravenous (IV) of iron per kg of body weight for a maximum of 200mg iron IV.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Serum Concentration (Cmax) |  | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. | 
| Time to Maximum Serum Concentration (Tmax) |  | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. | 
| Serum Terminal Phase Elimination Half-life (T1/2) |  | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. | 
| Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last) |  | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. | 
| Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞) |  | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. | 
| Terminal Phase Elimination Rate Constant (λz) |  | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Body Clearance (Cl) | Total body clearance: Cl = Dose/Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞) | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours. | 
| Initial Volume of Distribution (Vdc) |  | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. | 
| Volume of Distribution Based on the Terminal Phase (Vdarea) |  | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. | 
| Volume of Distribution at Steady State (Vdss) |  | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. | 
| Mean Residence Time (MRtime) |  | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. | 
| Number of Participants With Serious Adverse Events (SAE's) |  | Day of initial treatment with Venofer through 30 days after study treatment |