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AnemiaPhase 3NCT00442702

A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.

A Phase 3 study testing Mircera and Darbepoetin alfa in people with Anemia, run by Hoffmann-La Roche at 91 sites in 13 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 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia
What is being tested?
Mircera and Darbepoetin alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
228 participants
Where
91 sitesin 13 countries
Study dates
Sep 2007to Aug 2010
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 kidney disease, not requiring dialysis;
  • receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and during screening/baseline period.

Who cannot join

  • 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.

Trial locations and contacts

91 sites in 13 countries.

91 sites in 13 countries

Italy12 sites

  • Study site

    Brescia, 25123

  • Study site

    Chieti, 66013

  • Study site

    Ferrara, 44100

  • Study site

    Genova, 16132

  • Study site

    La Spezia, 19124

  • Study site

    Lecco, 23900

  • Study site

    Lodi, 26900

  • Study site

    Palermo, 90127

  • Study site

    Pavia, 27100

  • Study site

    Prato, 50047

  • Study site

    Roma, 00186

  • Study site

    S Fermo Della Battaglia, 22020

Other trials in Italy

United States11 sites

  • Study site

    Augusta, Georgia, 30309

  • Study site

    Chattanooga, Tennessee, 37404

  • Study site

    Granada Hills, California, 91344

  • Study site

    Lauderdale Lakes, Florida, 33313

  • Study site

    Mineola, New York, 11501

  • Study site

    Morgantown, West Virginia, 26506

  • Study site

    Orchard Park, New York, 14127

  • Study site

    Oregon City, Oregon, 97045

  • Study site

    Providence, Rhode Island, 02903

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Salem, Virginia, 24153

Other trials in United States

Spain10 sites

  • Study site

    A Coruña, 15006

  • Study site

    Barcelona, 08025

  • Study site

    Barcelona, 08035

  • Study site

    Barcelona, 08036

  • Study site

    Ciudad Real, 13005

  • Study site

    L'Hospitalet de Llobregat, 08907

  • Study site

    Lleida, 25198

  • Study site

    Madrid, 28007

  • Study site

    Málaga, 29010

  • Study site

    Partida La Ceñuela. Torreviej, 03186

Other trials in Spain

Germany8 sites

  • Study site

    Bad Hersfeld, 36251

  • Study site

    Bad König, 64732

  • Study site

    Berlin, 13353

  • Study site

    Bonn, 53127

  • Study site

    Coburg, 96450

  • Study site

    Demmin, 17109

  • Study site

    Dortmund, 44263

  • Study site

    München, 80331

Other trials in Germany

Hungary8 sites

  • Study site

    Baja, 6500

  • Study site

    Budapest, 1071

  • Study site

    Esztergom, 2500

  • Study site

    Hódmezővásárhely, 6800

  • Study site

    Kalocsa, 6300

  • Study site

    Kecskemét, 6001

  • Study site

    Szigetvár, 7390

  • Study site

    Vác, 2600

Other trials in Hungary

Poland8 sites

  • Study site

    Gdansk, 80-211

  • Study site

    Katowice, 40-027

  • Study site

    Lodz, 90-153

  • Study site

    Radom, 20-610

  • Study site

    Rzeszów, 35-055

  • Study site

    Sieradz, 98-200

  • Study site

    Szczecin, 70-111

  • Study site

    Warsaw, 02-006

Other trials in Poland

Canada7 sites

  • Study site

    Calgary, Alberta, T2N 2T9

  • Study site

    Kingston, Ontario, K7L 3N6

  • Study site

    Mississauga, Ontario, L5M 2V8

  • Study site

    Montreal, Quebec, H2X 3J4

  • Study site

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Study site

    Toronto, Ontario, M5G 2C4

  • Study site

    Toronto, Ontario, M9N 1N8

Other trials in Canada

France7 sites

  • Study site

    La Tronche, 38700

  • Study site

    Nantes, 44035

  • Study site

    Orléans, 45100

  • Study site

    Paris, 75475

  • Study site

    Rennes, 35033

  • Study site

    Saint-Priest-en-Jarez, 42277

  • Study site

    Strasbourg, 67091

Other trials in France

Australia5 sites

  • Study site

    Adelaide, SA 5000

  • Study site

    Gosford, 2250

  • Study site

    Lismore, 2480

  • Study site

    Reservoir, 3073

  • Study site

    Richmond, 3121

Other trials in Australia

Israel5 sites

  • Study site

    Hadera, 38100

  • Study site

    Jerusalem, 91031

  • Study site

    Kfar Saba, 44281

  • Study site

    Nahariya, 22100

  • Study site

    Rehovot, 76100

Other trials in Israel

Czechia4 sites

  • Study site

    Mariánské Lázně, 35301

  • Study site

    Prague, 128 08

  • Study site

    Prague, 14021

  • Study site

    Prague, 14200

Other trials in Czechia

United Kingdom4 sites

  • Study site

    Belfast, BT9 7LJ

  • Study site

    Birmingham, B15 2TH

  • Study site

    Bradford, BD5 0NA

  • Study site

    Exeter, EX2 5DW

Other trials in United Kingdom

Belgium2 sites

  • Study site

    Aalst, 9300

  • Study site

    Roeselare, 8800

Other trials in Belgium

About this study

Official 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.

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.

Conditions
Anemia
Being tested
Mircera, Darbepoetin alfa
Medical subject headings
Anemia

What participants receive

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

  • MirceraDrug

    Also called RO0503821, Methoxy polyethylene glycol-epoetin beta

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

  • Darbepoetin alfaDrug

    Also called Aranesp®

    As prescribed, subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling specifications.

Study groups in NCT00442702
Study groupRoleWhat they receive
MirceraExperimentalParticipants 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.
Receives: Drug: Mircera
Darbepoetin alfaActive comparatorParticipants 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).
Receives: Drug: Darbepoetin alfa

What is being measured

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

  1. 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.

    Measured: 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 outcomes (3)

  1. Change in Hemoglobin Concentration From Baseline Over Time

    Measured: From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit.

  2. 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.

    Measured: From randomization to Month 9

  3. 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.

    Measured: Randomization to Month 10 (final visit)

Timeline

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

  1. First posted2 Mar 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionAug 2010
  4. Study completionAug 2010

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
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00442702
Sponsor's protocol ID
BH20051
Status last verified
Dec 2011
First submitted
1 Mar 2007
Last updated
19 Dec 2011

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mircera and Darbepoetin alfa in people with Anemia, run by Hoffmann-La Roche at 91 sites in 13 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 3 inclusion and 4 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 19 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in Italy, United States, Spain, Germany, Hungary and 8 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 3 Oct 2011). 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?

Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period (time frame: 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).). 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 NCT00442702, which also lists 1 linked publication.

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 19 Dec 2011.

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