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AnemiaPhase 3NCT00394953

A Study of Mircera for the Maintenance 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 88 sites in 14 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, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney disease (CKD) who are on hemodialysis. 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
490 participants
Where
88 sitesin 14 countries
Study dates
Dec 2006to Nov 2008
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;
  • hemodialysis 3 times weekly for >=12 weeks before screening, and during screening/baseline period;
  • 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 malignancy;

Trial locations and contacts

88 sites in 14 countries.

88 sites in 14 countries

France21 sites

  • Study site

    Auch, 32000

  • Study site

    Bordeaux, 33000

  • Study site

    Boulogne, 62321

  • Study site

    Castelnau-le-Lez, 34170

  • Study site

    Cergy-Pontoise, 95303

  • Study site

    Chamalières, 63400

  • Study site

    Dijon, 21079

  • Study site

    Fleury-Mérogis, 91712

  • Study site

    Hérouville-Saint-Clair, 14202

  • Study site

    La Tronche, 38701

  • Study site

    Lyon, 69437

  • Study site

    Montpellier, 34295

  • Study site

    Nîmes, 30029

  • Study site

    Paris, 75015

  • Study site

    Paris, 75970

  • Study site

    Reims, 51092

  • Study site

    Rennes, 35033

  • Study site

    Saint-Brieuc, 22027

  • Study site

    Saint-Herblain, 44093

  • Study site

    Saint-Ouen, 93400

  • Study site

    Villeurbanne, 69100

Other trials in France

Spain17 sites

  • Study site

    Alicante, 03010

  • Study site

    Badalona, 08915

  • Study site

    Barcelona, 08003

  • Study site

    Barcelona, 08036

  • Study site

    Bilbao, 48013

  • Study site

    Córdoba, 14004

  • Study site

    León, 24071

  • Study site

    Madrid, 28003

  • Study site

    Madrid, 28035

  • Study site

    Madrid, 28040

  • Study site

    Madrid, 28041

  • Study site

    Madrid, 28046

  • Study site

    Madrid, 28222

  • Study site

    Ourense, 32005

  • Study site

    Santander, 39008

  • Study site

    Vigo, 36204

  • Study site

    Vigo, 36205

Other trials in Spain

Canada8 sites

  • Study site

    Calgary, Alberta, T2N 2T9

  • Study site

    Greenfield Park, Quebec, J4V 2H1

  • Study site

    Hamilton, Ontario, L8N 4A6

  • Study site

    Kitchener, Ontario, N2G 1N9

  • Study site

    Mississauga, Ontario, L5M 2V8

  • Study site

    Ottawa, Ontario, K1H 7W9

  • Study site

    Toronto, Ontario, M5G 2C4

  • Study site

    Trois-Rivières, Quebec, G8Z 4K8

Other trials in Canada

Italy8 sites

  • Study site

    Bologna, 40138

  • Study site

    Como, 22100

  • Study site

    Genova, 16132

  • Study site

    Lecco, 23900

  • Study site

    Modena, 41100

  • Study site

    Pavia, 27100

  • Study site

    Prato, 50047

  • Study site

    Venezia, 30122

Other trials in Italy

Germany6 sites

  • Study site

    Bad Hersfeld, 36251

  • Study site

    Bonn, 53127

  • Study site

    Dortmund, 44263

  • Study site

    München, 80804

  • Study site

    Stuttgart, 70191

  • Study site

    Villingen-Schwenningen, 78054

Other trials in Germany

United Kingdom6 sites

  • Study site

    Belfast, BT9 7LJ

  • Study site

    Canterbury, CT1 3NE

  • Study site

    Glasgow, G4 OSF

  • Study site

    London, SE22 8PT

  • Study site

    Manchester, M13 9WL

  • Study site

    Truro, TR1 3LJ

Other trials in United Kingdom

Australia5 sites

  • Study site

    Adelaide, SA 5000

  • Study site

    Clayton, 3186

  • Study site

    Gosford, 2250

  • Study site

    Parkville, 3052

  • Study site

    Woolloongabba, 4102

Other trials in Australia

Belgium4 sites

  • Study site

    Aalst, 9300

  • Study site

    Brussels, 1020

  • Study site

    Brussels, 1200

  • Study site

    Roeselare, 8800

Other trials in Belgium

Austria3 sites

  • Study site

    Linz, 4010

  • Study site

    Vienna, 1090

  • Study site

    Vienna, 1220

Other trials in Austria

Denmark3 sites

  • Study site

    Aalborg, 9100

  • Study site

    Hillerød, 3400

  • Study site

    Roskilde, 4000

Other trials in Denmark

Finland2 sites

  • Study site

    Tampere, 33521

  • Study site

    Turku, 20521

Other trials in Finland

Netherlands2 sites

  • Study site

    Amsterdam, 1081 HV

  • Study site

    Dordrecht, 3318 AT

Other trials in Netherlands

Switzerland2 sites

  • Study site

    Aarau, 5001

  • Study site

    Lausanne, 1003

Other trials in Switzerland

Portugal1 site

  • Study site

    Leiria, 2400-441

Other trials in Portugal

About this study

Official title: A Randomized, Controlled, Open Label, Multicenter, Parallel-group Study to Compare the Effect of Mircera With That of Darbepoetin Alfa, Administered Intravenously at Extended Dosing Intervals, for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Hemodialysis

This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney disease (CKD) who are on hemodialysis. Eligible patients receiving once-weekly intravenous (IV) darbepoetin alfa maintenance treatment will be randomized to receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360 micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study) or intravenous darbepoetin alfa every 2 weeks before switching to once monthly administration. The anticipated time on study treatment is 3-12 months, 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

    Also called Aranesp

    As prescribed, iv.

  • methoxy polyethylene glycol-epoetin beta [Mircera]Drug

    120, 200 or 360 micrograms iv / month, starting dose

Study groups in NCT00394953
Study groupRoleWhat they receive
MIRCERAExperimentalEligible participants with anemia in CKD who were on hemodialysis will receive methoxy polyethylene glycol-epoetin beta (MIRCERA [RO0503821]) IV once every month up to 52 weeks. The starting dose of MIRCERA which will be administered during the treatment period will depend on the dose of darbepoetin alfa administered during screening period i.e., 120, 200 and 360 mcg for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Darbepoetin AlfaActive comparatorEligible participants with anemia in CKD who were on hemodialysis will receive darbepoetin alfa (Aranesp) IV once every two weeks up to 26 weeks and darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
Receives: Drug: Darbepoetin alfa

What is being measured

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

  1. Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period

    Randomized participants with an average hemoglobin (Hb) decrease from Baseline (Week -4 to Week -1) not exceeding 1.0 gram per deciliter (g/dL) and an absolute average Hb >= 10.5 g/dL during the evaluation period (Weeks 50-53) were defined as responders. Non-responders included participants without any Hb data during the second treatment period and those who did not meet the response criteria and thus were not included in the analysis.

    Measured: Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53)

Secondary outcomes (5)

  1. Mean Percentage Change in MIRCERA and Darbepoetin Alpha Dose Over Time

    All participants received once monthly treatment schedule of both MIRCERA and darbepoetin alpha for the respective treatment arms after Week 27 and these analyses are based on the absolute doses. The average dose in Months 11 and 12 was defined as the mean of all administered doses between study Days 302 and 363. The change in dose was calculated as the percentage change between the respective dose at Week 27 and the average corresponding dose during Months 11 and 12 in each treatment group.

    Measured: Week 27 to Month 12

  2. Number of Participants With Marked Laboratory Abnormality Over Time

    Values of laboratory parameters higher (H) or lower (L) than the Roche defined reference range were considered as abnormality. The laboratory parameters with abnormality were platelets, white blood cells (WBC), albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and potassium. Blood samples were drawn before drug administration and before the dialysis session.

    Measured: Up to Week 53

  3. Median Blood Pressure Over Time

    Systolic and diastolic blood pressures (BP) were measured before and after the dialysis session at every week from Baseline (Week -4 to Week -1) to Week 53. Median pre-dialysis diastolic blood pressure (PrD DBP) , median post-dialysis diastolic blood pressure (PoD DBP), median pre-dialysis systolic blood pressure (PrD SBP), and post-dialysis systolic blood pressure (PoD SBP) were reported at Baseline (Week -4 to Week -1) , Week 28 and Week 52.

    Measured: Baseline (Week -4 to Week -1), Week 28, and Week 52

  4. Mean Pulse Rate Over Time

    Pulse rate is defined as the number of heartbeats in a minute and was assessed in sitting position of the participants at every week from Baseline (Week -4 to Week -1) to Week 53. Summary data of mean values of pulse rate are presented at Baseline (Week -4 to Week -1), Week 28 and Week 52.

    Measured: Baseline (Week -4 to Week -1), Week 28, and Week 52

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

    An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any adverse event that can result in death or is life-threatening or required in participants hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above. SAEs were reported up to Week 56, while nonserious AEs up to Week 52.

    Measured: From screening to Week 56

Timeline

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

  1. First posted2 Nov 2006 (estimated)
  2. Study startDec 2006
  3. Primary completionNov 2008
  4. Study completionNov 2008

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
490 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00394953
Sponsor's protocol ID
BH17847
Status last verified
Nov 2016
First submitted
1 Nov 2006
Last updated
20 Jan 2017

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

  • Carrera F, Lok CE, de Francisco A, Locatelli F, Mann JF, Canaud B, Kerr PG, Macdougall IC, Besarab A, Villa G, Kazes I, Van Vlem B, Jolly S, Beyer U, Dougherty FC; PATRONUS Investigators. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Nephrol Dial Transplant. 2010 Dec;25(12):4009-17. doi: 10.1093/ndt/gfq305. Epub 2010 Jun 3.

    PubMed 20522670

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 88 sites in 14 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 3 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 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in France, Spain, Canada, Italy, Germany and 9 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 20 Jan 2017). 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?

Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period (time frame: Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53)). 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 NCT00394953, 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 20 Jan 2017.

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