Phase 2
N=11
Iron Sucrose in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00721188 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: Maximum Observed Serum Concentration (Cmax) — 8545.33 ug/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Venofer (Drug)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- American Regent, Inc.
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Serum Concentration (Cmax) |
8545.33 | — |
| PRIMARY Time to Maximum Serum Concentration (Tmax) |
0.56 | — |
| PRIMARY Serum Terminal Phase Elimination Half-life (T1/2) |
8.04 | — |
| PRIMARY Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last) |
31304.84 | — |
| PRIMARY Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞) |
36293.39 | — |
| PRIMARY Terminal Phase Elimination Rate Constant (λz) |
0.15 | — |
| SECONDARY Total Body Clearance (Cl) |
6.03 | — |
| SECONDARY Initial Volume of Distribution (Vdc) |
22.46 | — |
| SECONDARY Volume of Distribution Based on the Terminal Phase (Vdarea) |
63.83 | — |
| SECONDARY Volume of Distribution at Steady State (Vdss) |
40.27 | — |
| SECONDARY Mean Residence Time (MRtime) |
7.16 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAE's) |
— | — |
Summary
The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron Sucrose Injection) in NDD-CKD pediatric patients.
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
Data sourced from ClinicalTrials.gov (NCT00721188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.