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AnemiaPhase 3NCT00077766

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

A Phase 3 study testing Darbepoetin alfa and methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 48 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia
What is being tested?
Darbepoetin alfa and methoxy polyethylene glycol-epoetin beta [Mircera]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
313 participants
Where
48 sitesin 12 countries
Study dates
Mar 2004to Aug 2005
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

48 sites in 12 countries.

48 sites in 12 countries

Canada8 sites

  • Study site

    Calgary, Alberta, T2N 2T9

  • Study site

    Edmonton, Alberta, T6G 2B7

  • Study site

    Halifax, Nova Scotia, B3H 1V8

  • Study site

    Kamloops, British Columbia, V2C 2T1

  • Study site

    Kitchener, Ontario, N2G 1N9

  • Study site

    Mississauga, Ontario, L5M 2V8

  • Study site

    Vancouver, British Columbia, V5Z 1M9

  • Study site

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Spain7 sites

  • Study site

    Badalona, 08915

  • Study site

    Barcelona, 08036

  • Study site

    Córdoba, 10004

  • Study site

    Madrid, 28035

  • Study site

    Oviedo, 33006

  • Study site

    Salamanca, 37008

  • Study site

    Santander, 39008

Other trials in Spain

Australia6 sites

  • Study site

    Blacktown, NSW 2148

  • Study site

    Brisbane, 4102

  • Study site

    Clayton, 3168

  • Study site

    Gosford, 2250

  • Study site

    Parkville, 3050

  • Study site

    Sydney, 1871

Other trials in Australia

France6 sites

  • Study site

    Aubervilliers, 93307

  • Study site

    Montpellier, 34295

  • Study site

    Nice, 06002

  • Study site

    Strasbourg, 67091

  • Study site

    Tarbes, 65013

  • Study site

    Toulouse, 31077

Other trials in France

Italy5 sites

  • Study site

    Bergamo, 24100

  • Study site

    Lecco, 23900

  • Study site

    Livorno, 57100

  • Study site

    Messina, 98158

  • Study site

    Pavia, 27100

Other trials in Italy

Belgium4 sites

  • Study site

    Aalst, 9300

  • Study site

    Brussels, 1070

  • Study site

    Brussels, 1200

  • Study site

    Liège, 4000

Other trials in Belgium

Denmark3 sites

  • Study site

    Aalborg, 9100

  • Study site

    Odense, 5000

  • Study site

    Roskilde, 4000

Other trials in Denmark

Germany3 sites

  • Study site

    Hannoversch Münden, 34346

  • Study site

    Nuremberg, 90431

  • Study site

    Villingen-Schwenningen, 78054

Other trials in Germany

Sweden2 sites

  • Study site

    Karlstad, 65185

  • Study site

    Stockholm, 18288

Other trials in Sweden

Switzerland2 sites

  • Study site

    Aarau, 5001

  • Study site

    Lausanne, 1003

Other trials in Switzerland

Austria1 site

  • Study site

    Graz, 8036

Other trials in Austria

Finland1 site

  • Study site

    HUS, 00029

Other trials in Finland

About this study

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.

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
Being tested
Darbepoetin alfa, methoxy polyethylene glycol-epoetin beta [Mircera]
Medical subject headings
Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Darbepoetin alfaDrug

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

  • 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).

Study groups in NCT00077766
Study groupRoleWhat they receive
RO0503821 (1x/2 Weeks)ExperimentalEligible 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).
Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Darbepoetin (1x/1-2 Weeks)Active comparatorEligible participants will be administered with darbepoetin alfa IV, every week or every 2 weeks during Weeks 1 through 52.
Receives: Drug: Darbepoetin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)

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

    The average Hb of all values recorded during the evaluation period was calculated, and this average was subtracted from the average baseline Hb values for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline Hb concentration is displayed. The evaluation period was defined as Week 29 to Week 36.

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

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

    A combined data of the number of participants who received Red Blood Cell (RBC) transfusions during the titration and evaluation periods is reported. A period of 28 weeks after the first dose of the study drug was used for dose titration and stabilization of Hb concentration. The dose titration period was followed by an 8-week evaluation period (weeks 29 to 36).

    Measured: Week 1 to Week 36

  3. Number of Participants With Marked Laboratory Abnormalities

    A marked abnormality range was defined as above and/or below a value which was considered to be potentially clinically relevant. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the reference range of the following laboratory parameters: White blood cells (WBC) (3.0- 18.0 10^9/liter [L]), platelets (100 - 550 10^9/L), (alanine aminotransferase [(ALAT)] (0 - 110 units per liter [U/L]), alkaline phosphatase (ALP) (0 - 220 U/L), aspartate aminotransferase (ASAT) (0 - 80 U/L), albumin >= 30 g/L, phosphate (0.75 - 1.60 millimole per liter [mmol/L]), potassium (2.9 - 5.8 mmol/L), glucose (2.80 - 11.10 mmol/L).

    Measured: Up to Week 52

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

    Blood pressure Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) was measured by manual assessment or automated reading throughout the study for every participant. Blood pressure was taken in the sitting position after at least 5 minutes rest. An appropriate -sized cuff was used and both systolic and diastolic blood pressures were recorded before dialysis (BD) and after dialysis (AD).

    Measured: Baseline, Week 36, and Week 52

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

    Change in pulse rate (beats per minute [bpm]) from baseline values includes only those participants with both a baseline (BL) value and a value for specified time period.

    Measured: Baseline, Week 36, and Week 52

  6. Number of Participants With Any Adverse Events, Any Serious Adverse Event, and Deaths

    An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. Overall deaths occurred in the study were reported.

    Measured: Up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2004 (estimated)
  2. Study startMar 2004
  3. Primary completionAug 2005
  4. Study completionAug 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
313 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00077766
Sponsor's protocol ID
BA17283
Status last verified
Nov 2015
First submitted
12 Feb 2004
Last updated
26 Oct 2016

Publications

  • 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.

    PubMed 36791280

  • 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.

    PubMed 18586762

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Darbepoetin alfa and methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 48 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Canada, Spain, Australia, France, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period (time frame: Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00077766, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.

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