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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00442702




Registration number
NCT00442702
Ethics application status
Date submitted
1/03/2007
Date registered
2/03/2007
Date last updated
19/12/2011

Titles & IDs
Public title
A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.
Scientific title
An Open-label, Randomized, Multi-center, Parallel Group Non-inferiority Study of Subcutaneous Injections of RO0503821 Given Once Monthly vs. Darbepoetin Alfa Given According to Local Label in Patients With Chronic Kidney Disease Who Are Not on Dialysis.
Secondary ID [1] 0 0
BH20051
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
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mircera
Treatment: Drugs - Darbepoetin alfa

Experimental: Mircera - Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.

Active Comparator: Darbepoetin alfa - Participants continued to receive the same dose of darbepoetin alfa as before screening by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).


Treatment: Drugs: Mircera
Starting dose of 120, 200 and 360 micrograms administered by subcutaneous injection once a month.

Treatment: Drugs: Darbepoetin alfa
As prescribed, subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling specifications.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period - A time adjusted average baseline hemoglobin (Hb) concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the two month evaluation period. The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.
Timepoint [1] 0 0
Baseline (measurements at Week -4, Week -2 and Day 1) and Evaluation Period (Months 8 and 9; measurements twice a month and at the final visit).
Secondary outcome [1] 0 0
Change in Hemoglobin Concentration From Baseline Over Time
Timepoint [1] 0 0
From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit.
Secondary outcome [2] 0 0
Number of Participants With Red Blood Cell (RBC) Transfusions - Red blood cell (RBC) transfusions could be given during the treatment period in case of medical need, i.e., in severely anemic patients with recognized symptoms or signs of anemia (e.g., in patients with acute blood loss, with severe angina, or whose Hemoglobin decreased to critical levels). The number of participants who had at least one red blood cell transfusion during the entire study, during the Titration Period and during the Evaluation Period is presented. Participants who received more than one transfusion within a defined period are only counted once.
Timepoint [2] 0 0
From randomization to Month 9
Secondary outcome [3] 0 0
Participants With Adverse Events - Adverse events were collected during the treatment period (from the first treatment dose) up to 30 days after last dose or at least until the date of last contact if the date of last contact occurred after the specified 30 day period.
Timepoint [3] 0 0
Randomization to Month 10 (final visit)

Eligibility
Key inclusion criteria
- adult patients, >=18 years of age;

- chronic kidney disease, not requiring dialysis;

- receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and
during screening/baseline period.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- overt gastrointestinal bleeding within 8 weeks before screening, or during
screening/baseline period;

- transfusion of red blood cells within 8 weeks before screening, or during
screening/baseline period;

- active malignant disease;

- previous treatment with Mircera.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Gosford
Recruitment hospital [3] 0 0
- Lismore
Recruitment hospital [4] 0 0
- Reservoir
Recruitment hospital [5] 0 0
- Richmond
Recruitment postcode(s) [1] 0 0
SA 5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2480 - Lismore
Recruitment postcode(s) [4] 0 0
3073 - Reservoir
Recruitment postcode(s) [5] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Florida
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United States of America
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Georgia
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New York
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North Carolina
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Oregon
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Rhode Island
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Tennessee
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United States of America
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Virginia
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United States of America
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West Virginia
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Belgium
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Aalst
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Belgium
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Roeselare
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Canada
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Alberta
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Canada
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Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Quebec
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Marianske Lazne
Country [18] 0 0
Czech Republic
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Praha 2
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Czech Republic
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Praha 4
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Czech Republic
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Praha
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France
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La Tronche
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France
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Nantes
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France
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Orleans
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France
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Paris
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France
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Rennes
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France
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St Priest En Jarez
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France
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Strasbourg
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Germany
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Bad Hersfeld
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Germany
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Bad König
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Coburg
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Germany
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Demmin
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Germany
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Dortmund
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Germany
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München
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Hungary
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Baja
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Hungary
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Budapest
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Esztergom
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Hodmezovasarhely
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Kalocsa
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Kecskemet
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Szigetvar
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VAC
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Israel
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Hadera
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Nahariya
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Israel
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Rehovot
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Italy
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Brescia
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Italy
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Chieti
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Italy
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Ferrara
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Italy
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Genova
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Italy
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La Spezia
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Italy
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Lecco
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Italy
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Lodi
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Italy
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Palermo
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Italy
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Pavia
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Italy
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Prato
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Italy
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Roma
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Italy
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S Fermo Della Battaglia
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Poland
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Gdansk
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Katowice
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Lodz
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Radom
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Rzeszow
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Sieradz
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Poland
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Szczecin
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Poland
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Warszawa
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Spain
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Barcelona
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Spain
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Ciudad Real
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Spain
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Hospitalet de Llobregat
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Spain
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La Coruna
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Spain
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Lerida
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Partida La Ceñuela. Torreviej
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United Kingdom
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Belfast
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United Kingdom
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Birmingham
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United Kingdom
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Bradford
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United Kingdom
State/province [80] 0 0
Exeter

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the
treatment of anemia in patients with chronic kidney disease who are not on dialysis and who
are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized
either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly
subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the
weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The
anticipated time on study treatment is 3-12 months, and the target sample size is 100-500
individuals.
Trial website
https://clinicaltrials.gov/show/NCT00442702
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
Other publications