Trial Outcomes & Findings for Iron Sucrose in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients (NCT NCT00721188)

NCT ID: NCT00721188

Last Updated: 2018-02-20

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 11 participants
• Primary outcome timeframe: 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.
• Results posted on: 2018-02-20

Participant Flow

Recruitment period: January 2006 to July 2008 Location: Hospital

Participant milestones

Measure	Venofer (Iron Sucrose Injection) All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Venofer (Iron Sucrose Injection) n=11 Participants All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
Age, Categorical <=18 years	11 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	13.5 years STANDARD_DEVIATION 1.51 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment Mexico	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Venofer (Iron Sucrose Injection) n=9 Participants All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
Maximum Observed Serum Concentration (Cmax)	8545.33 ug/dL Standard Deviation 4118.54

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Venofer (Iron Sucrose Injection) n=9 Participants All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
Time to Maximum Serum Concentration (Tmax)	0.56 hour Standard Deviation 0.17

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Venofer (Iron Sucrose Injection) n=8 Participants All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
Serum Terminal Phase Elimination Half-life (T1/2)	8.04 hour Standard Deviation 4.51

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Venofer (Iron Sucrose Injection) n=9 Participants All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
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/dL Standard Deviation 9850.48

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Venofer (Iron Sucrose Injection) n=8 Participants All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)	36293.39 ug/dL Standard Deviation 12228.76

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Venofer (Iron Sucrose Injection) n=8 Participants All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
Terminal Phase Elimination Rate Constant (λz)	0.15 1/hour Standard Deviation 0.15

SECONDARY outcome

Timeframe: 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-∞)

Outcome measures

Measure	Venofer (Iron Sucrose Injection) n=8 Participants All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
Total Body Clearance (Cl)	6.03 dL/hour Standard Deviation 1.81

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Venofer (Iron Sucrose Injection) n=9 Participants All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
Initial Volume of Distribution (Vdc)	22.46 dL Standard Deviation 14.12

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Venofer (Iron Sucrose Injection) n=8 Participants All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
Volume of Distribution Based on the Terminal Phase (Vdarea)	63.83 dL Standard Deviation 30.28

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Venofer (Iron Sucrose Injection) n=8 Participants All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
Volume of Distribution at Steady State (Vdss)	40.27 dL Standard Deviation 20.00

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Venofer (Iron Sucrose Injection) n=8 Participants All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
Mean Residence Time (MRtime)	7.16 hour Standard Deviation 4.08

SECONDARY outcome

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

Outcome measures

Measure	Venofer (Iron Sucrose Injection) n=11 Participants All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
Number of Participants With Serious Adverse Events (SAE's)	0 participants

Adverse Events

Venofer (Iron Sucrose Injection)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Venofer (Iron Sucrose Injection) n=11 participants at risk All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
Vascular disorders Hypotension	9.1% 1/11 • Number of events 1 • Day of initial treatment with Venofer through 30 days after study treatment

Additional Information

Mark A. Falone, MD

Luitpold Pharmaceuticals, Inc.

Phone: 610-650-4200

Email: mfalone@luitpold.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60