Treatment of Anemia in Diabetic Subjects With CKD - Full Text View

Sponsors and Collaborators:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Ortho Biotech Products, L.P.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00240734

Purpose

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.

Condition	Intervention	Phase
Anemia	Drug: Epoetin alfa	Phase II

MedlinePlus related topics: Anemia

Drug Information available for: Erythropoietin Epoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

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 Outcome Measures:

The secondary endpoints include evaluation of health-related quality life, hemoglobin change over time, time to hemoglobin response, and transfusion utilization.

Estimated Enrollment:	180
Study Start Date:	March 2005
Study Completion Date:	September 2005

Detailed 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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240734

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Ortho Biotech Products, L.P.

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

Additional Information:

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) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CR004597
Study First Received:	October 14, 2005
Last Updated:	April 24, 2008
ClinicalTrials.gov Identifier:	NCT00240734 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Anemia
pre-dialysis
diabetic
Chronic renal failure

Study placed in the following topic categories:

Epoetin Alfa
Hematinics
Hematologic Diseases
Renal Insufficiency, Chronic

Anemia
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Epoetin Alfa
Hematinics
Hematologic Diseases
Therapeutic Uses

Hematologic Agents
Anemia
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009