VIT45 Versus Oral Iron in the 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:
NCT00317239
First received: April 20, 2006
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).


Condition Intervention Phase
Anemia
Drug: Ferrous Sulfate tablets
Drug: Ferric Carboxymaltose (FCM)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Safety & Efficacy of a Unique Intravenous Iron (VIT45) Preparation vs Oral Iron 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:
  • Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL [ Time Frame: anytime during the study ] [ Designated as safety issue: No ]

Enrollment: 255
Study Start Date: May 2005
Study Completion Date: August 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ferric Carboxymaltose (FCM)
A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
Drug: Ferric Carboxymaltose (FCM)
A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
Active Comparator: Ferrous Sulfate tablets
325 mg/TID x 8 weeks
Drug: Ferrous Sulfate tablets
325 mg/TID x 8 weeks

Detailed Description:

This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females > or = 12 years of age
  • NDD-CKD subjects
  • Baseline hemoglobin < or = 11g/dl
  • Stable erythropoietin (EPO) status

Exclusion Criteria:

  • Known hypersensitivity to ferrous sulfate or IV iron
  • Unstable EPO status
  • Anemia not related to CKD
  • Chronic, serious infection
  • Recent IV iron
  • Recent blood transfusion
  • Recent blood loss
  • Need for surgery
  • Received investigational drug within 30 days
  • 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: NCT00317239

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

Publications:
Qunibi W, Martinez C, Smith M, Benjamin J, Mangione A. A Randomized Controlled Trial Comparing Intravenous Ferric Carboxymaltose to Oral Iron in Anemic Patients with Non-Dialysis-Dependent CKD. American Society of Nephrology Renal Week 2007.
Qunibi W, Martinez C, Smith M, Benjamin J, Dinh Q. A Randomized Controlled Trial Comparing IV Ferric Carboxymaltose (FCM) to Oral Iron in Anemic Patients with Non-Dialysis-Dependent CKD. American Society of Nephrology Renal Week 2007.

Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00317239     History of Changes
Other Study ID Numbers: 1VIT04004
Study First Received: April 20, 2006
Results First Received: September 16, 2013
Last Updated: September 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Luitpold Pharmaceuticals:
Anemia
Chronic Kidney Disease
Iron

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Ferric Compounds
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014