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

Sponsor:	Luitpold Pharmaceuticals
Information provided by:	Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00317226

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.

Condition	Intervention	Phase
Anemia	Drug: VIT45	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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 VIT45 in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

Resource links provided by NLM:

MedlinePlus related topics: Anemia Iron Kidney Failure

Drug Information available for: Ferric carboxymaltose

U.S. FDA Resources

Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:

Incidence and severity of adverse events

Secondary Outcome Measures:

Percentage of patients achieving a clinical success

Enrollment:	145
Study Start Date:	June 2005
Study Completion Date:	October 2006

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
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects who completed or discontinued Protocol 1VIT04004

Exclusion Criteria:

Known hypersensitivity to ferrous sulfate or intravenous (IV) iron
Anemia not related to CKD
Chronic, serious infection
Recent IV iron
Recent blood transfusion
Recent blood loss
Need for surgery or dialysis
Female subjects who are pregnant or lactating

Contacts and Locations

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

Locations

United States, Pennsylvania
Luitpold Pharmaceuticals Inc.
Norristown, Pennsylvania, United States, 19518

Sponsors and Collaborators

Luitpold Pharmaceuticals

Investigators

Study Director:

Antoinette Mangione, MD

Luitpold Pharmaceuticals

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00317226 History of Changes
Other Study ID Numbers:	1VIT05005
Study First Received:	April 20, 2006
Last Updated:	January 15, 2009
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
Kidney Failure, Chronic
Renal Insufficiency, Chronic

Hematologic Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on February 09, 2012