Text Size

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:
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00317226
First received: April 20, 2006
Last updated: January 15, 2009
Last verified: January 2009
History of Changes
  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 3

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:

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
Renal Insufficiency, Chronic
Kidney Failure, Chronic
 Hematologic Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 21, 2013