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Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

Primary Purpose

Anemia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ferric Carboxymaltose (FCM)
Sponsored by
American Regent, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia, CKD, Chronic Kidney Disease, Iron, Maintenance Dose

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects who completed or discontinued Protocol 1VIT04004 Exclusion Criteria: Known hypersensitivity reaction to VIT-45 Anemia not related to CKD Chronic, serious infection Recent IV iron other than study drug in past 12 weeks Recent blood loss within the last 12 weeks Need for surgery or dialysis Female subjects who are pregnant or lactating

Sites / Locations

  • Luitpold Pharmaceuticals Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ferric Carboxymaltose (FCM)

Arm Description

maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit

Outcomes

Primary Outcome Measures

Incidence of Treatment-emergent Adverse Events

Secondary Outcome Measures

Full Information

First Posted
April 20, 2006
Last Updated
January 22, 2018
Sponsor
American Regent, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00317226
Brief Title
Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
Official Title
Open Label Extension Study Evaluating the Long Term Safety, Tolerability and Efficacy of an Iron Maintenance Dosing Strategy Utilizing Intravenous VIT45 in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Regent, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004 (NCT00317239).
Detailed Description
The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004. In this study patients that complete protocol 1VIT 04004 or are discontinued will be offered to participate in this extension study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Anemia, CKD, Chronic Kidney Disease, Iron, Maintenance Dose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferric Carboxymaltose (FCM)
Arm Type
Experimental
Arm Description
maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit
Intervention Type
Drug
Intervention Name(s)
Ferric Carboxymaltose (FCM)
Intervention Description
maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit
Primary Outcome Measure Information:
Title
Incidence of Treatment-emergent Adverse Events
Time Frame
44 week study duration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who completed or discontinued Protocol 1VIT04004 Exclusion Criteria: Known hypersensitivity reaction to VIT-45 Anemia not related to CKD Chronic, serious infection Recent IV iron other than study drug in past 12 weeks Recent blood loss within the last 12 weeks Need for surgery or dialysis Female subjects who are pregnant or lactating
Facility Information:
Facility Name
Luitpold Pharmaceuticals Inc.
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

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