- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00146224
Efficacy of Epoetin Alfa Deep Tank in Treatment of Anemia in Patients With Chronic Kidney Disease Receiving Hemodialysis
February 25, 2010 updated by: Amgen
A Randomized, Double-Blind, Equivalence Study of the Efficacy of Epoetin Alfa Manufactured by Deep Tank Bioreactor Technology and Epoetin Alfa Manufactured by Roller-Bottle Technology for the Treatment of Anemia in Patients With Chronic Kidney Disease (CKD) Receiving Hemodialysis
The purpose of this study is to evaluate whether the efficacy of Epoetin alfa DT is equivalent to that of Epoetin alfa RB for the treatment of anemia in patients with CKD receiving hemodialysis
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
420
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria: - Diagnosis of CKD and receiving hemodialysis for greater than or equal to 3 months before randomization - Mean HB level between 10 and 13 g/dL (inclusive) (mean of 2 values drawn at least 3 days apart during the screening period) - Currently receiving a stable dose of Epoetin alfa RB (i.e., EPOGEN® or PROCRIT®) for at least 6 weeks prior to randomization.
Stable is defined as: less than or equal to 25% change in dose over 6 weeks, same frequency and route of administration with no more than 1 missed or withheld dose during each of the two three-week periods before randomization Exclusion Criteria: - Uncontrolled hypertension, defined as a pre-dialysis systolic BP greater than 180 and/or diastolic BP of greater than 110 during the screening period - Known history of severe hyperparathyroidism (PTH Greater than 1500 pg/ml within 3 months prior to enrollment) - Currently receiving immunosuppressive therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Epoetin alfa DT
|
Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.
|
Active Comparator: Epoetin alfa RB
|
Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ratio of weekly dose at the evaluation period to the weekly dose at baseline
Time Frame: Entire Study
|
Entire Study
|
Change in Heloglobin level between the screening period and the evaluation period
Time Frame: Entire Study
|
Entire Study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline Hb at each measurement timepoint
Time Frame: Entire Study
|
Entire Study
|
Maintaining Hemoglobin within range at each measurement timepoint
Time Frame: Entire Study
|
Entire Study
|
Average Epoetin alfa dose over evaluation period
Time Frame: evaluation period (weeks 21 - 28)
|
evaluation period (weeks 21 - 28)
|
Change from baseline dose at each measurement timepoint
Time Frame: entire study
|
entire study
|
Epoetin alfa seroreactivity
Time Frame: entire study
|
entire study
|
Subject incidence, nature and severity of adverse events
Time Frame: entire study
|
entire study
|
Hemoglobin variability
Time Frame: entire study
|
entire study
|
changes from baseline laboraotry and vital sign parameters
Time Frame: entire study
|
entire study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
January 1, 2007
Study Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
September 6, 2005
First Submitted That Met QC Criteria
September 6, 2005
First Posted (Estimate)
September 7, 2005
Study Record Updates
Last Update Posted (Estimate)
February 26, 2010
Last Update Submitted That Met QC Criteria
February 25, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20050113
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nephrology
-
Mahidol UniversityMinistry of Health, Thailand; Bhumirajanagarindra Kidney Institute, ThailandCompletedImmunology | Nephrology
-
AmgenCompletedCardiovascular Disease | Hyperparathyroidism | End Stage Renal Disease | Chronic Kidney Disease | Secondary Hyperparathyroidism | Chronic Renal Failure | Coronary Artery Calcification | Vascular Calcification | Kidney Disease | Calcification | Nephrology
-
University Hospital, ToursRecruitingKidney Diseases | Hemolytic Uremic Syndrome | Acute Kidney Injury | Thrombotic Microangiopathy | NephrologyFrance
Clinical Trials on Epoetin alfa RB
-
AmgenTerminatedChronic Kidney Disease
-
Hospital de Clinicas de Porto AlegreOswaldo Cruz Foundation; Rio Grande do Sul State Health Department - SES/RSCompletedComparison of the Efficacy of Two Formulations of Epoetin in Patients Undergoing Hemodialysis
-
M.D. Anderson Cancer CenterCompleted
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech, Inc.Completed
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Products, L.P.CompletedKidney Diseases | Anemia
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedBlood Transfusion | Orthopedic Surgery | Orthopedic Procedures | Mammaplasty | Cardiovascular Surgical Procedures | Blood Transfusion, Autologous
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Products, L.P.Terminated
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Products, L.P.CompletedCritical Illness | Anemia
-
Johnson & Johnson Pharmaceutical Research & Development...Completed