Treatment of Anemia in Diabetic Subjects With CKD

Anemia Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-Controlled Study Evaluating Weekly Epoetin Alfa (PROCRIT�) Administration on Hemoglobin Response and Safety in Diabetic Subjects With the Anemia of Chronic Kidney Disease (CKD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00240734
• Other study ID #: CR004597
• Status: Terminated
• Phase: Phase 2
• First received: October 14, 2005
• Last updated: June 8, 2011
• Start date: March 2005
• Est. completion date: September 2005

Study information

• Verified date: March 2010
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the proportion of subjects receiving either Epoetin alfa (PROCRIT®) or placebo who are able to achieve a hemoglobin response, defined by at least a 1 gram/deciliter increase from baseline by Week 17.

Description:

This is a prospective, randomized, double blind, placebo controlled, multi-center study in diabetic subjects with the anemia of chronic kidney disease. Subjects will be randomly assigned in a 1:1 ratio to receive either Epoetin alfa (PROCRIT®) or matching placebo for sixteen weeks. Epoetin alfa (PROCRIT®) is indicated for the treatment of anemia associated with chronic renal failure (pre-dialysis), non-myeloid malignancies receiving chemotherapy, in HIV-infected subjects receiving zidovudine therapy, and in anemic subjects undergoing elective non-cardiac, non-vascular surgery to reduce the need for allogenic blood transfusion during high-volume blood loss procedures. This study is being undertaken to assess, under well-controlled conditions, the effect of weekly Epoetin alfa (PROCRIT®) treatment on hemoglobin response in diabetic subjects with the anemia of chronic kidney disease. The study hypothesis is that weekly PROCRIT treatment will be effective in achieving a hemoglobin response than placebo, where hemoglobin response is defined by at least a 1 gram/deciliter increase from baseline by Week 17. The subjects are administered study drug (PROCRIT® or matching placebo) once weekly by subcutaneous injection by a health care professional for 16 weeks. The initial dose of study drug is either PROCRIT® 10,000 U (1.0 mL) or matching placebo. The maximum dose administered is 20,000 U (2.0 mL).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with a clinical diagnosis of diabetes mellitus

• History of documented proteinuria or microalbuminuria

• A glomerular filtration rate between 15 and 90 mL/minute/1.73m2

• Subjects with hemoglobin greater than or equal to 9.0 /dL and less than or equal to 11.0 g/dL.

Exclusion Criteria:

• A current diagnosis of poorly controlled high blood pressure (hypertension) (systolic blood pressure > 150 mm Hg or diastolic blood pressure > 100 mm Hg) after adequate anti hypertensive therapy

• Subjects with severe neuropathy or peripheral vascular disease with gait instability

• Subjects scheduled to receive dialysis during the course of the study

• Subjects with a transferrin saturation < 20% or ferritin level < 50 ng/dL

• Subjects with active malignancy, defined as a malignancy requiring current therapy (surgery, chemotherapy, or radiotherapy) or a history of treatment for malignancy in the last 5 years.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• Epoetin alfa

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Ortho Biotech Products, L.P.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the hemoglobin response rate, defined as the proportion of subjects who achieve at least a 1 gram per deciliter hemoglobin increase from baseline by Week 17.
Secondary	The secondary endpoints include evaluation of health-related quality life, hemoglobin change over time, time to hemoglobin response, and transfusion utilization.

External Links

•   A Randomized, Double-Blind, Placebo-Controlled Study Evaluating Weekly PROCRIT (Epoetin alfa) Administration on Hemoglobin Response and Safety in Diabetic Subjects with the Anemia of Chronic Kidney Disease (CKD)