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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00317226
• Other study ID #: 1VIT05005
• Status: Completed
• Phase: Phase 3
• First received: April 20, 2006
• Last updated: January 22, 2018
• Start date: June 2005
• Est. completion date: September 2007

Study information

• Verified date: January 2018
• Source: Luitpold Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: September 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Luitpold Pharmaceuticals Inc.	Norristown	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Luitpold Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-emergent Adverse Events		44 week study duration