VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: Ferrous Sulfate tablets; Drug: Ferric Carboxymaltose (FCM)

• Registration Number: NCT00317239
• Lead Sponsor: American Regent, Inc.

Brief Summary

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).

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).

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2006-04-20
• Study First Submitted QC: 2006-04-20
• Study First Posted: 2006-04-24
• Primary Completion: 2007-02
• Study Completion: 2007-08
• Results First Submitted: 2013-09-16
• Results First Submitted QC: 2013-09-16
• Results First Posted: 2013-11-25
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ferrous Sulfate tablets	Ferrous Sulfate tablets	325 mg/TID x 8 weeks
Ferric Carboxymaltose (FCM)	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL	anytime during the study

Trial Locations

Locations (1)

Luitpold Pharmaceuticals; 🇺🇸 Norristown, Pennsylvania, United States