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

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ClinicalTrials.gov Identifier: NCT00317226
Recruitment Status : Completed
First Posted : April 24, 2006
Results First Posted : June 10, 2015
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Luitpold Pharmaceuticals

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).

Condition or disease Intervention/treatment Phase
Anemia Drug: Ferric Carboxymaltose (FCM) Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2005
Actual Primary Completion Date : March 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ferric Carboxymaltose (FCM)
maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit
Drug: Ferric Carboxymaltose (FCM)
maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit



Primary Outcome Measures :
  1. Incidence of Treatment-emergent Adverse Events [ Time Frame: 44 week study duration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317226


Locations
United States, Pennsylvania
Luitpold Pharmaceuticals Inc.
Norristown, Pennsylvania, United States, 19403
Sponsors and Collaborators
Luitpold Pharmaceuticals

Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00317226     History of Changes
Other Study ID Numbers: 1VIT05005
First Posted: April 24, 2006    Key Record Dates
Results First Posted: June 10, 2015
Last Update Posted: February 20, 2018
Last Verified: January 2018

Keywords provided by Luitpold Pharmaceuticals:
Anemia
CKD
Chronic Kidney Disease
Iron
Maintenance Dose

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Ferric Compounds
Hematinics