Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
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
1 other identifier
interventional
145
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 20, 2006
CompletedFirst Posted
Study publicly available on registry
April 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedResults Posted
Study results publicly available
June 10, 2015
CompletedFebruary 20, 2018
January 1, 2018
1.7 years
April 20, 2006
September 16, 2013
January 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-emergent Adverse Events
44 week study duration
Study Arms (1)
Ferric Carboxymaltose (FCM)
EXPERIMENTALmaximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit
Interventions
maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit
Eligibility Criteria
You may qualify if:
- Subjects who completed or discontinued Protocol 1VIT04004
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Luitpold Pharmaceuticals Inc.
Norristown, Pennsylvania, 19403, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark Falone, MD
- Organization
- Luitpold Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2006
First Posted
April 24, 2006
Study Start
June 1, 2005
Primary Completion
March 1, 2007
Study Completion
September 1, 2007
Last Updated
February 20, 2018
Results First Posted
June 10, 2015
Record last verified: 2018-01