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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:	EUCTR
Last refreshed on:	8 May 2012
Main ID:	EUCTR2004-004178-10-SE
Date of registration:	23/12/2004
Prospective Registration:	Yes
Primary sponsor:	Amgen Limited
Public title:	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
Scientific title:	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:	22/02/2005
Target sample size:	420
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-004178-10
Study type:	Interventional clinical trial of medicinal product
Study design:	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)
Phase:

Countries of recruitment
Czech Republic	Germany	Spain	Sweden	United Kingdom

Contacts

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Affiliation:

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Key inclusion & exclusion criteria

Inclusion criteria:
· =18 years of age.
· Diagnosis of CKD and receiving hemodialysis for = 3 months before enrollment
· No prior exposure to EPREX or NeoRecorman.
· Baseline Hb between 10 and 13 g/dL
· On stable weekly or once every other week IV or SC darbepoetin alfa 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.
· Acute myocardial ischemia; hospitalization for congestive heart failure or myocardial infarction within 12 weeks before enrollment.
· 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.
· 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.
· Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic kidney disease
MedDRA version: 6.1 Level: LLT Classification code 10038444

Intervention(s)

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

Primary Outcome(s)

Main Objective: To evalute 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 hemodialysis as measured by the mean change in hemoglobin between baseline and the evaluation period and the ratio of dosing requirements between baseline and the evaluation period.

Primary end point(s): • Change in Hb level between the screening period and the evaluation period
• The ratio of weekly dose at the evaluation period to the weekly dose at baseline.

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.

Secondary Outcome(s)

Secondary ID(s)

20040104

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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