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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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8 May 2012 |
Main ID: |
EUCTR2004-004178-10-CZ |
Date of registration:
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24/01/2005 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Randomized, Double-Blind, Equivalence Study of the Efficacy of Darbepoetin Alfa Manufactured by Serum Free Bioreactor Technology and Darbepoetin Alfa Manufactured by Roller-Bottle Technology for the Treatment of Anemia in Patients with Chronic Kidney Disease Receiving Hemodialysis
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Scientific title:
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A Randomized, Double-Blind, Equivalence Study of the Efficacy of Darbepoetin Alfa Manufactured by Serum Free Bioreactor Technology and Darbepoetin Alfa Manufactured by Roller-Bottle Technology for the Treatment of Anemia in Patients with Chronic Kidney Disease Receiving Hemodialysis |
Date of first enrolment:
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21/02/2005 |
Target sample size:
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420 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-004178-10 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Darbepoetin alfa (roller bottle)
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Phase:
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Countries of recruitment
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Czech Republic
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Germany
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Spain
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Sweden
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: · =18 years of age. · Diagnosis of CKD and receiving hemodialysis for = 3 months before enrollment · No prior exposure to EPREX or NeoRecormon. · Baseline Hb between 10 and 13 g/dL · On stable weekly or once every other week IV or SC Aranesp therapy for at least 6 weeks prior to screening (stable is defined as = 25% change in weekly dose and no change in frequency) · Adequate iron stores (serum ferritin = 100 µg/L) · Before any study-specific procedure, the appropriate written informed consent must be obtained Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: · Scheduled to receive a kidney transplant. · Uncontrolled hypertension, defined as a pre-dialysis systolic BP > 180 and/or diastolic BP of > 110. · Prior history (within 12 weeks before enrollment) of CV events including: a. Acute myocardial ischemia b. Hospitalization for congestive heart failure c. Myocardial infarction d. Deep vein thrombosis e. Cerebrovascular event (stroke or transient ischemic attack) · Parathyroid hormone (PTH) level > 1500 pg/mL · Major surgery within 12 weeks before enrollment (excluding vascular access surgery). · Currently receiving antibiotic therapy for systemic infection. · Known positive HIV antibody or positive hepatitis B surface antigen. · Clinical evidence of current malignancy and/or receiving systemic hemotherapy/radiotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia. · Red blood cell (RBC) transfusions within 8 weeks before enrollment. · Androgen therapy within 8 weeks before enrollment. · Systemic hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematologic malignancy; myeloma; hemolytic anemia). · Any disorder that may impact (in the judgment of the investigator) the ability to give informed consent for participation in this study or to comply with study procedures. · Pregnant or breast-feeding women. All subjects must practice adequate contraception (in the judgment of the investigator) throughout this trial. · Treatment with an investigational agent or device within 30 days before enrollment or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study. · Subject has known sensitivity to any of the products to be administered during dosing.
Age minimum:
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Chronic kidney disease MedDRA version: 6.1
Level: LLT
Classification code 10038444
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Intervention(s)
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Trade Name: Aranesp Product Name: Darbepoetin Alfa 10 µg/0.4 ml Prefilled Syringe Pharmaceutical Form: Solution for injection INN or Proposed INN: Darbepoetin Alfa Other descriptive name: 10 µg/0.4 ml Prefilled Syringe Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 25-
Trade Name: Aranesp Product Name: Darbepoetin Alfa 15 µg/0.375 ml Prefilled Syringe Pharmaceutical Form: Solution for injection INN or Proposed INN: Darbepoetin Alfa Other descriptive name: 15 µg/0.375 ml Prefilled Syringe Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 40-
Trade Name: Aranesp Product Name: Darbepoetin Alfa 20 µg/0.5 ml Prefilled Syringe Pharmaceutical Form: Solution for injection INN or Proposed INN: Darbepoetin Alfa Other descriptive name: 20 µg/0.5 ml Prefilled Syringe Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 40-
Trade Name: Aranesp Product Name: Darbepoetin Alfa 30 µg/0.3 ml Prefilled Syringe Pharmaceutical Form: Solution for injection INN or Proposed INN: Darbepoetin Alfa Other descriptive name: 30 µg/0.3 ml Prefilled Syringe Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 100-
Trade Name: Aranesp Product Name: Darbepoetin Alfa 40 µg/0.4 ml Prefilled Syringe Pharmaceutical Form: Solution for injection INN or Proposed INN: Darbepoetin Alfa Other descriptive name: 40 µg/0.4 ml Prefilled Syringe Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 100-
Trade Name: Aranesp Product Name: Darbepoetin Alfa 50 µg/0.5 ml Prefilled Syringe Pharmaceutical Form: Solution for injection INN or Proposed INN: Darbepoetin Alfa Other descriptive name: 50 µg/0.5 ml Prefilled Syringe Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 100-
Trade Name: Aranesp Product Name: Darbepoetin Alfa 60 µg/0.3
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Primary Outcome(s)
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Secondary Objective: To evaluate whether the safety and tolerability of darbepoetin alfa SF is similar to that of darbepoetin alfa RB for the treatment of anemia in patients with CKD receiving dialysis.
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Main Objective: To evaluate whether the efficacy of darbepoetin alfa SF is equivalent to that of darbepoetin alfa RB for the treatment of anemia in patients with CKD receiving dialysis.
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Primary end point(s): • Change in Hb level between the baseline period and the evaluation period • The ratio of weekly dosing requirements between baseline and the evaluation period.
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Secondary ID(s)
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2004-004178-10-SE
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20040104
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Source(s) of Monetary Support
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Results
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Results available:
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