Clinical trial NCT00077766: A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.
Official title: A Randomized, Controlled, Open-label, Multi-center, Parallel-group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Intravenously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2004-02-16
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* on dialysis therapy for at least 12 weeks before screening;
* receiving darbepoetin alfa iv for at least 8 weeks before screening.

Exclusion Criteria:

* women who are pregnant, breastfeeding or using unreliable birth control methods;
* administration of another investigational drug within 4 weeks before screening, or during the study period.

Primary outcomes:
measure: Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period
timeFrame: Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)
Secondary outcomes:
measure: Number of Participants Maintaining Average Hemoglobin Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hemoglobin Concentration
timeFrame: Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)
measure: Number of Participants With Red Blood Cell Transfusions During the Dose Titration and Evaluation Periods
timeFrame: Week 1 to Week 36
measure: Number of Participants With Marked Laboratory Abnormalities
timeFrame: Up to Week 52
measure: Mean Change in Blood Pressure From Baseline at Week 36 and Week 52
timeFrame: Baseline, Week 36, and Week 52
measure: Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52
timeFrame: Baseline, Week 36, and Week 52
measure: Number of Participants With Any Adverse Events, Any Serious Adverse Event, and Deaths
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Blacktown
country: Australia
city: Brisbane
country: Australia
city: Clayton
country: Australia
city: Gosford
country: Australia
city: Parkville
country: Australia
city: Sydney
country: Australia
city: Graz
country: Austria
city: Aalst
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Liege
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Kamloops
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Halifax
country: Canada
state: Nova Scotia
city: Kitchener
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Aalborg
country: Denmark
city: Odense
country: Denmark
city: Roskilde
country: Denmark
city: HUS
country: Finland
city: Aubervilliers
country: France
city: Montpellier
country: France
city: Nice
country: France
city: Strasbourg
country: France
city: Tarbes
country: France
city: Toulouse
country: France
city: Hann. Münden
country: Germany
city: Nürnberg
country: Germany
city: Villingen-schwenningen
country: Germany
city: Bergamo
country: Italy
city: Lecco
country: Italy
city: Livorno
country: Italy
city: Messina
country: Italy
city: Pavia
country: Italy
city: Badalona
country: Spain
city: Barcelona
country: Spain
city: Córdoba
country: Spain
city: Madrid
country: Spain
city: Oviedo
country: Spain
city: Salamanca
country: Spain
city: Santander
country: Spain
city: Karlstad
country: Sweden
city: Stockholm
country: Sweden
city: Aarau
country: Switzerland
city: Lausanne
country: Switzerland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Canaud B, Mingardi G, Braun J, Aljama P, Kerr PG, Locatelli F, Villa G, Van Vlem B, McMahon AW, Kerloeguen C, Beyer U; STRIATA Study Investigators. Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. Nephrol Dial Transplant. 2008 Nov;23(11):3654-61. doi: 10.1093/ndt/gfn320. Epub 2008 Jun 27.