NCT00239642

Brief Summary

Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney disease (CKD) patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

January 10, 2012

Completed
Last Updated

November 17, 2021

Status Verified

October 1, 2021

Enrollment Period

3.5 years

First QC Date

October 13, 2005

Results QC Date

December 5, 2011

Last Update Submit

October 19, 2021

Conditions

AnemiaChronic Kidney Disease

Keywords

IronAnemiaCKD

Outcome Measures

Primary Outcomes (1)

  • Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event

    Safety Profile: Number of subjects who experienced at least 1 adverse event in each arm

    baseline through week 12

Secondary Outcomes (8)

  • Number of Subjects Achieving Clinical Success

    anytime during the 12 week post-baseline period

  • Percentage (%) of Subjects Achieving Clinical Success

    anytime during the 12 week post-baseline period

  • Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive

    anytime during the 12-week post-baseline period

  • Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive

    anytime during the 12 week post-baseline period

  • Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive

    anytime during the 12 week post-baseline period

  • +3 more secondary outcomes

Study Arms (3)

Venofer (0.5 mg/kg)

EXPERIMENTAL

0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Drug: Venofer (iron sucrose injection)

Venofer (1.0 mg/kg)

EXPERIMENTAL

1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Drug: Venofer (iron sucrose injection)

Venofer (2.0 mg/kg)

EXPERIMENTAL

2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Drug: Venofer (iron sucrose injection)

Interventions

Venofer (iron sucrose injection)DRUG

0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Venofer (0.5 mg/kg)

Eligibility Criteria

Age2 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients between 2 to 21 years of age
  • Patients on stable hemodialysis (HD) or peritoneal dialysis (PD) regimen for 3 months for ≥ 3 months
  • Non-dialysis dependent (NDD) patients with glomerular filtration rate (GFR) \<60
  • Hemoglobin (Hgb) ≥ 11g/dL to ≤ 13.5g/dL
  • Ferritin ≤ 800 ng/mL
  • Transferrin saturation (TSAT) ≥ 20% to ≤ 50%
  • Received stable erythropoietin (EPO) regimen for ≥ 8 weeks prior to the qualifying screening visit

You may not qualify if:

  • Known hypersensitivity to iron sucrose
  • Severe diseased of the liver, cardiovascular system, or hemopoietic system
  • Serious infection requiring hospitalization
  • Significant blood loss within the last 3 months
  • Bleeding disorders
  • Pregnancy / Lactation
  • Actively being treated for asthma
  • Hemoglobinopathy
  • Receiving a myelosuppressive drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luitpold Pharmaceutials

Norristown, Pennsylvania, 19403, United States

Location

MeSH Terms

Conditions

AnemiaRenal Insufficiency, Chronic

Interventions

Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ferric CompoundsIron CompoundsInorganic ChemicalsGlucaric AcidSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Results Point of Contact

Title
Mark A. Falone, MD
Organization
Luitpold Pharmaceuticals, Inc.
mfalone@luitpold.com
601-650-4200

Study Officials

  • Mark A Falone, MD

    American Regent, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

July 1, 2005

Primary Completion

January 1, 2009

Study Completion

April 1, 2010

Last Updated

November 17, 2021

Results First Posted

January 10, 2012

Record last verified: 2021-10

Locations

US(1)