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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00317226
First received: April 20, 2006
Last updated: June 8, 2015
Last verified: June 2015
  Purpose
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 Intervention Phase
Anemia
Drug: Ferric Carboxymaltose (FCM)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Incidence of Treatment-emergent Adverse Events [ Time Frame: 44 week study duration ] [ Designated as safety issue: Yes ]

Enrollment: 145
Study Start Date: June 2005
Study Completion Date: September 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317226

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

Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00317226     History of Changes
Other Study ID Numbers: 1VIT05005 
Study First Received: April 20, 2006
Results First Received: September 16, 2013
Last Updated: June 8, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 26, 2016