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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00090753




Registration number
NCT00090753
Ethics application status
Date submitted
3/09/2004
Date registered
6/09/2004
Date last updated
14/02/2012

Titles & IDs
Public title
A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia
Scientific title
An Open-label, Multi-center Study to Document the Efficacy, Safety, and Tolerability of Long-term Administration of RO0503821 in Patients With Chronic Renal Anemia
Secondary ID [1] 0 0
BH18387
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anemia 0 0
Condition category
Condition code
Blood 0 0 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Methoxy Polyethylene Glycol-Epoetin Beta
Treatment: Drugs - Epoetin alfa
Treatment: Drugs - Epoetin beta
Treatment: Drugs - Darbepoetin alfa

Experimental: Methoxy Polyethylene Glycol-Epoetin Beta - Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.

Active Comparator: Comparator ESA - Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.


Treatment: Drugs: Methoxy Polyethylene Glycol-Epoetin Beta
Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in 2-mL glass vials containing 1 mL solution or in single-use sterile pre-filled syringes (PFSs) containing 0.3 mL or 0.6 mL injectable solution. The injectable solution was available in vials with the following strengths: 50, 100, 200, 400, and 1000 µg/mL. The injectable solution was available in PFSs with the following strengths: 30, 40, 50, 60, 75, 100, 120, 150, 200, and 250 µg/0.3 mL; and 360 and 400 µg/0.6 mL.

Treatment: Drugs: Epoetin alfa
Epoetin alfa was provided with commercial packaging in English with country-specific labels (10,000 IU, 20,000 IU).

Treatment: Drugs: Epoetin beta
Epoetin beta was provided with commercial packaging in English with country-specific labels (50,000 IU, 100,000 IU).

Treatment: Drugs: Darbepoetin alfa
Darbepoetin alfa was provided with commercial packaging in English with country-specific labels (vials and PFSs in various strengths).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation
Timepoint [1] 0 0
Baseline to the end of the study (Up to 49 Months)
Secondary outcome [1] 0 0
Percentage of Patients Who Had at Least 1 Adverse Event
Timepoint [1] 0 0
From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)

Eligibility
Key inclusion criteria
- Written informed consent

- Adult patients (= 18 years old) with chronic renal anemia

- Maintenance erythropoietic therapy with methoxy polyethylene glycol-epoetin beta or a
protocol-specified reference medication (epoetin alfa formulated with human albumin,
epoetin beta or darbepoetin alfa) in one of the following studies:
BA16528[NCT00048048], BA16285[NCT00048035], BA16286[NCT00364832],
BA16736[NCT00077597], BA16738[NCT00081471], BA16739[NCT00077610],
BA16740[NCT00077623], BA17283[NCT00077766] and BA17284[NCT00081484]

- Hemoglobin (Hb) concentration between 10.5 and 13.0 g/dL

- Adequate iron status defined as serum ferritin = 100 ng/mL or Transferrin Saturation
(TSAT)= 20% or percentage of hypochromic red blood cells (RBCs) < 10%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Poorly controlled hypertension

- History of epileptic seizure

- Pure red cell aplasia

- Chronic congestive heart failure [New York Heart Association (NYHA) IV]

- High likelihood of early withdrawal or interruption of the study

- Active malignant disease (except non-melanoma skin cancer)

- Life expectancy less than 12 months

- Pregnancy or breast-feeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2009
Sample size
Target
Accrual to date
Final
1228
Recruitment in Australia
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- Clayton
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- Gosford
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- Liverpool
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- Parkville
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- Perth
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- Sydney
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- Woolloongabba
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3186 - Clayton
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2250 - Gosford
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1871 - Liverpool
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3050 - Parkville
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6847 - Perth
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NSW 2148 - Sydney
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or
subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients
with renal anemia. Eligible patients were those who were receiving stable maintenance therapy
with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in
Phase II or III clinical studies. They continued to receive methoxy polyethylene
glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of
administration (sc or iv) as in the qualifying studies.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00090753
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00090753