Study Stopped
This study was stopped for slow enrollment after enrolling only 11 of 180 patients in six months time.
Treatment of Anemia in Diabetic Subjects With CKD
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)
1 other identifier
interventional
11
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2005
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 14, 2005
CompletedFirst Posted
Study publicly available on registry
October 18, 2005
CompletedJune 10, 2011
March 1, 2010
October 14, 2005
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
The secondary endpoints include evaluation of health-related quality life, hemoglobin change over time, time to hemoglobin response, and transfusion utilization.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
PMID: 36791280DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 14, 2005
First Posted
October 18, 2005
Study Start
March 1, 2005
Study Completion
September 1, 2005
Last Updated
June 10, 2011
Record last verified: 2010-03