A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.

NCT00077766 | Completed Phase 3 Results

• 1 other identifier: BA17283
• Study Type: interventional
• Target: 313
• Locations: 11 countries
• Sites: 47

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.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period

  A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve approach, for both periods separately. Change in Hb concentration between the baseline (Week -4 to Week -1) and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. The analysis used the last observation carried forward (LOCF) for missing Hb values for correction of the impact of early drop outs. The baseline period was defined as Week -4 to Week -1. The evaluation period was defined as Week 29 to Week 36.

  Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)

Secondary Outcomes (6)

• Number of Participants Maintaining Average Hemoglobin Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hemoglobin Concentration

  Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)

• Number of Participants With Red Blood Cell Transfusions During the Dose Titration and Evaluation Periods

  Week 1 to Week 36

• Number of Participants With Marked Laboratory Abnormalities

  Up to Week 52

• Mean Change in Blood Pressure From Baseline at Week 36 and Week 52

  Baseline, Week 36, and Week 52

• Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52

  Baseline, Week 36, and Week 52

Study Arms (2)

RO0503821 (1x/2 Weeks)

EXPERIMENTAL

Eligible participants will be administered with RO0503821 (\[methoxy polyethylene glycol-epoetin beta\] {Mircera}) intravenously (IV), every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 micro gram \[µg\]) was based on the dose of darbepoetin alfa at the time of randomization (\< 40, 40 to 80, or \> 80 µg per week, respectively).

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Darbepoetin (1x/1-2 Weeks)

ACTIVE COMPARATOR

Eligible participants will be administered with darbepoetin alfa IV, every week or every 2 weeks during Weeks 1 through 52.

Drug: Darbepoetin alfa

Interventions

Darbepoetin alfa DRUG

Darbepoetin alfa was administered IV, every week or every 2 weeks during Weeks 1 through 52.

Darbepoetin (1x/1-2 Weeks)

methoxy polyethylene glycol-epoetin beta [Mircera] DRUG

RO0503821 was administered IV, every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 micro gram \[µg\]) was based on the dose of darbepoetin alfa at the time of randomization (\< 40, 40 to 80, or \> 80 µg per week, respectively).

RO0503821 (1x/2 Weeks)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (48)

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Blacktown, NSW 2148, Australia

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Brisbane, 4102, Australia

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Clayton, 3168, Australia

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Gosford, 2250, Australia

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Parkville, 3050, Australia

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Sydney, 1871, Australia

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Graz, 8036, Austria

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Aalst, 9300, Belgium

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Brussels, 1070, Belgium

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Brussels, 1200, Belgium

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Liège, 4000, Belgium

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Calgary, Alberta, T2N 2T9, Canada

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Edmonton, Alberta, T6G 2B7, Canada

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Kamloops, British Columbia, V2C 2T1, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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Winnipeg, Manitoba, R3A 1R9, Canada

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Halifax, Nova Scotia, B3H 1V8, Canada

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Kitchener, Ontario, N2G 1N9, Canada

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Mississauga, Ontario, L5M 2V8, Canada

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Aalborg, 9100, Denmark

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Odense, 5000, Denmark

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Roskilde, 4000, Denmark

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HUS, 00029, Finland

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Aubervilliers, 93307, France

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Montpellier, 34295, France

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Nice, 06002, France

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Strasbourg, 67091, France

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Tarbes, 65013, France

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Toulouse, 31077, France

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Hannoversch Münden, 34346, Germany

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Nuremberg, 90431, Germany

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Villingen-Schwenningen, 78054, Germany

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Bergamo, 24100, Italy

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Lecco, 23900, Italy

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Livorno, 57100, Italy

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Messina, 98158, Italy

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Pavia, 27100, Italy

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Badalona, 08915, Spain

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Barcelona, 08036, Spain

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Córdoba, 10004, Spain

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Madrid, 28035, Spain

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Oviedo, 33006, Spain

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Salamanca, 37008, Spain

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Santander, 39008, Spain

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Karlstad, 65185, Sweden

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Stockholm, 18288, Sweden

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Aarau, 5001, Switzerland

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Lausanne, 1003, Switzerland

Location

Related Publications (2)

• Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

  PMID: 36791280 DERIVED

• 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.

  PMID: 18586762 DERIVED

MeSH Terms

Conditions

Anemia

Interventions

Darbepoetin alfa; continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2004
• First Posted: February 16, 2004
• Study Start: March 1, 2004
• Primary Completion: August 1, 2005
• Study Completion: August 1, 2005
• Last Updated: October 26, 2016
• Results First Posted: September 14, 2016

Record last verified: 2015-11

Locations

ES (7); IT (5); BE (4); SE (2); FR (6); CH (2); AU (6); CA (8); DK (3); FI (1); DE (3)