Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia

NCT00236977 | Completed Phase 3 Results

• 1 other identifier: 1VEN03027
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.

Conditions

Anemia

Keywords

CKD; iron; anemia

Outcome Measures

Primary Outcomes (1)

• Patients With an Increase in Hemoglobin >= 1gm/dL.

  Change from Baseline up to Day 56

Secondary Outcomes (6)

• Number of Subjects With a Clinical Response

  Change from Baseline up to Day 56

• Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56

  Change from Baseline up to Day 56

• Highest Change From Baseline in Ferritin (ng/mL) up to Day 56

  Change from Baseline up to Day 56

• Mean Change in Ferritin (ng/mL) From Baseline to Day 56

  Change from Baseline at Day 56

• Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56

  Change from Baseline at Day 56

Study Arms (2)

Venofer

EXPERIMENTAL

iron sucrose injection

Drug: Venofer

Ferrous Sulfate

ACTIVE COMPARATOR

oral iron

Drug: Ferrous Sulfate

Interventions

Venofer DRUG

iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.

Also known as: iron sucrose tablets

Venofer

Ferrous Sulfate DRUG

oral iron tablets; 325 mg three times a day orally for 56 days

Also known as: Oral Iron Tablets

Ferrous Sulfate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hemoglobin \< or = 11.5 gm/dL
• Stable dose or not receiving EPO
• Renal Anemia

You may not qualify if:

• IV iron with last 6 months
• Chronic infection, malignancy,major surgery within last month
• Blood Transfusion with last two months
• Significant blood loss within last 3 months
• Concomitant sever diseases of the liver

Sponsors & Collaborators

• American Regent, Inc.: lead

Study Sites (1)

Luitpold Pharmaceuticals

Valley Forge, Pennsylvania, 19403, United States

Location

Related Publications (1)

• Van Wyck DB, Roppolo M, Martinez CO, Mazey RM, McMurray S; United States Iron Sucrose (Venofer) Clinical Trials Group. A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD. Kidney Int. 2005 Dec;68(6):2846-56. doi: 10.1111/j.1523-1755.2005.00758.x.

  PMID: 16316362 RESULT

MeSH Terms

Conditions

Anemia

Interventions

Ferric Oxide, Saccharated; ferrous sulfate; Iron

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Metals, Heavy; Elements; Transition Elements; Metals

Results Point of Contact

• Title: Mark A. Falone, MD
• Organization: Luitpold Pharmaceuticals, Inc.

mfalone@luitpold.com

610-650-4200

Study Officials

• Mark A Falone, MD

  American Regent, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 7, 2005
• First Posted: October 12, 2005
• Study Start: August 1, 2003
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: October 6, 2020
• Results First Posted: March 9, 2010

Record last verified: 2020-09

Locations

US (1)