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

Anemia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721188
• Other study ID #: 1VEN05033
• Status: Completed
• Phase: Phase 2
• First received: July 21, 2008
• Last updated: January 22, 2018
• Start date: January 2006
• Est. completion date: January 2010

Study information

• Verified date: January 2018
• Source: Luitpold Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2010
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• Venofer
Single dose of 7mg intravenous (IV) of iron per kg of body weight for a maximum of 200mg iron IV.

Locations

Country	Name	City	State
United States	Luitpold Pharmaceuticals	Norristown	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Luitpold Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-8)		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.
Primary	Terminal Phase Elimination Rate Constant (?z)		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	Total Body Clearance (Cl)	Total body clearance: Cl = Dose/Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-8)	Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Number of Participants With Serious Adverse Events (SAE's)		Day of initial treatment with Venofer through 30 days after study treatment