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

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)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00721188
Enrollment
11
Registered
2008-07-23
Start date
2006-01-31
Completion date
2010-01-31
Last updated
2018-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Brief summary

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

Interventions

DRUGVenofer

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

Sponsors

American Regent, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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.
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.
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.
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.

Secondary

MeasureTime frameDescription
Total Body Clearance (Cl)Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours.Total body clearance: Cl = Dose/Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)
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—

Countries

United States

Participant flow

Recruitment details

Recruitment period: January 2006 to July 2008 Location: Hospital

Participants by arm

ArmCount
Venofer (Iron Sucrose Injection)
All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
11
Total11

Baseline characteristics

CharacteristicVenofer (Iron Sucrose Injection)
Age, Categorical
<=18 years
11 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous13.5 years
STANDARD_DEVIATION 1.51
Region of Enrollment
Mexico
11 participants
Sex: Female, Male
Female
6 Participants
Sex: Female, Male
Male
5 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
1 / 11
serious
Total, serious adverse events
0 / 11

Outcome results

Primary

Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Venofer (Iron Sucrose Injection)Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)36293.39 ug/dLStandard Deviation 12228.76
Primary

Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last)

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Venofer (Iron Sucrose Injection)Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last)31304.84 ug*hr/dLStandard Deviation 9850.48
Primary

Maximum Observed Serum Concentration (Cmax)

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Venofer (Iron Sucrose Injection)Maximum Observed Serum Concentration (Cmax)8545.33 ug/dLStandard Deviation 4118.54
Primary

Serum Terminal Phase Elimination Half-life (T1/2)

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Venofer (Iron Sucrose Injection)Serum Terminal Phase Elimination Half-life (T1/2)8.04 hourStandard Deviation 4.51
Primary

Terminal Phase Elimination Rate Constant (λz)

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Venofer (Iron Sucrose Injection)Terminal Phase Elimination Rate Constant (λz)0.15 1/hourStandard Deviation 0.15
Primary

Time to Maximum Serum Concentration (Tmax)

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Venofer (Iron Sucrose Injection)Time to Maximum Serum Concentration (Tmax)0.56 hourStandard Deviation 0.17
Secondary

Initial Volume of Distribution (Vdc)

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Venofer (Iron Sucrose Injection)Initial Volume of Distribution (Vdc)22.46 dLStandard Deviation 14.12
Secondary

Mean Residence Time (MRtime)

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Venofer (Iron Sucrose Injection)Mean Residence Time (MRtime)7.16 hourStandard Deviation 4.08
Secondary

Number of Participants With Serious Adverse Events (SAE's)

Time frame: Day of initial treatment with Venofer through 30 days after study treatment

ArmMeasureValue (NUMBER)
Venofer (Iron Sucrose Injection)Number of Participants With Serious Adverse Events (SAE's)0 participants
Secondary

Total Body Clearance (Cl)

Total body clearance: Cl = Dose/Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)

Time frame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours.

ArmMeasureValue (MEAN)Dispersion
Venofer (Iron Sucrose Injection)Total Body Clearance (Cl)6.03 dL/hourStandard Deviation 1.81
Secondary

Volume of Distribution at Steady State (Vdss)

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Venofer (Iron Sucrose Injection)Volume of Distribution at Steady State (Vdss)40.27 dLStandard Deviation 20
Secondary

Volume of Distribution Based on the Terminal Phase (Vdarea)

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Venofer (Iron Sucrose Injection)Volume of Distribution Based on the Terminal Phase (Vdarea)63.83 dLStandard Deviation 30.28

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026