NCT00317239

Brief Summary

This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
255

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2005

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

May 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

November 25, 2013

Completed
Last Updated

February 20, 2018

Status Verified

January 1, 2018

Enrollment Period

1.8 years

First QC Date

April 20, 2006

Results QC Date

September 16, 2013

Last Update Submit

January 22, 2018

Conditions

Anemia

Keywords

AnemiaChronic Kidney DiseaseIron

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL

    anytime during the study

Study Arms (2)

Ferric Carboxymaltose (FCM)

EXPERIMENTAL

A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.

Drug: Ferric Carboxymaltose (FCM)

Ferrous Sulfate tablets

ACTIVE COMPARATOR

325 mg/TID x 8 weeks

Drug: Ferrous Sulfate tablets

Interventions

Ferrous Sulfate tabletsDRUG

325 mg/TID x 8 weeks

Ferrous Sulfate tablets
Ferric Carboxymaltose (FCM)DRUG

A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.

Ferric Carboxymaltose (FCM)

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females \> or = 12 years of age
  • NDD-CKD subjects
  • Baseline hemoglobin \< or = 11g/dl
  • Stable erythropoietin (EPO) status

You may not qualify if:

  • Known hypersensitivity to ferrous sulfate or IV iron
  • Unstable EPO status
  • Anemia not related to CKD
  • Chronic, serious infection
  • Recent IV iron
  • Recent blood transfusion
  • Recent blood loss
  • Need for surgery
  • Received investigational drug within 30 days
  • Female subjects who are pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luitpold Pharmaceuticals

Norristown, Pennsylvania, 19403, United States

Location

Related Publications (2)

  • Qunibi WY, Martinez C, Smith M, Benjamin J, Mangione A, Roger SD. A randomized controlled trial comparing intravenous ferric carboxymaltose with oral iron for treatment of iron deficiency anaemia of non-dialysis-dependent chronic kidney disease patients. Nephrol Dial Transplant. 2011 May;26(5):1599-607. doi: 10.1093/ndt/gfq613. Epub 2010 Oct 7.

    PMID: 20929915RESULT

  • Qunibi W, Martinez C, Smith M, Benjamin J, Dinh Q. A Randomized Controlled Trial Comparing IV Ferric Carboxymaltose (FCM) to Oral Iron in Anemic Patients with Non-Dialysis-Dependent CKD. American Society of Nephrology Renal Week 2007.

    RESULT

MeSH Terms

Conditions

AnemiaRenal Insufficiency, Chronic

Interventions

Iron-Dextran Complexferric carboxymaltose

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)

Coordination ComplexesOrganic ChemicalsDextransGlucansPolysaccharidesCarbohydrates

Results Point of Contact

Title
Mark Falone
Organization
Luitpold Pharmaceuticals, Inc.
mfalone@luitpold.com
610-650-4200

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2006

First Posted

April 24, 2006

Study Start

May 1, 2005

Primary Completion

February 1, 2007

Study Completion

August 1, 2007

Last Updated

February 20, 2018

Results First Posted

November 25, 2013

Record last verified: 2018-01

Locations

US(1)