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AnemiaPhase 3NCT00077610

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

A Phase 3 study testing Epoetin alfa or beta, RO0503821 (1x/2 Weeks) and RO0503821 (1x/4 Weeks) in people with Anemia, run by Hoffmann-La Roche at 99 sites in 8 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 Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia
What is being tested?
Epoetin alfa or beta, RO0503821 (1x/2 Weeks) and RO0503821 (1x/4 Weeks)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
673 participants
Where
99 sitesin 8 countries
Study dates
Feb 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 IV epoetin 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

99 sites in 8 countries.

99 sites in 8 countries

United States60 sites

  • Study site

    Albuquerque, New Mexico, 87131

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Augusta, Georgia, 30901

  • Study site

    Austin, Texas, 78705

  • Study site

    Birmingham, Alabama, 35211

  • Study site

    Boston, Massachusetts, 02115

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Brooklyn, New York, 11203

  • Study site

    Brooklyn Center, Minnesota, 55430

  • Study site

    Burlington, Vermont, 05401

  • Study site

    Chapel Hill, North Carolina, 27599-7155

  • Study site

    Chattanooga, Tennessee, 37404

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Cincinnati, Ohio, 45267-0585

  • Study site

    Colorado Springs, Colorado, 80909

  • Study site

    Covington, Louisiana, 70433

  • Study site

    Denver, Colorado, 80262

  • Study site

    Detroit, Michigan, 48202-2689

  • Study site

    Encino, California, 91356

  • Study site

    Erie, Pennsylvania, 16502

  • Study site

    Fairfax, Virginia, 22031

  • Study site

    Great Neck, New York, 11021

  • Study site

    Houston, Texas, 77054

  • Study site

    Houston, Texas, 77099

  • Study site

    Irvine, California, 92868

  • Study site

    Lakewood, Colorado, 80260

  • Study site

    Los Angeles, California, 90095

  • Study site

    Louisville, Kentucky, 40202-1718

  • Study site

    Marshfield, Wisconsin, 54449

  • Study site

    Maywood, Illinois, 60153

  • Study site

    Mineola, New York, 11501

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Monterey Park, California, 91754

  • Study site

    Montgomery, Alabama, 36106

  • Study site

    Nashville, Tennessee, 37205

  • Study site

    Nashville, Tennessee, 37232

  • Study site

    New York, New York, 10021

  • Study site

    New York, New York, 10128

  • Study site

    Ocala, Florida, 34471

  • Study site

    Orangeburg, South Carolina, 29118

  • Study site

    Paterson, New Jersey, 07503

  • Study site

    Pembroke Pines, Florida, 33028

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Pittsburgh, Pennsylvania, 15224

  • Study site

    Pittsburgh, Pennsylvania, 15261

  • Study site

    Portland, Oregon, 97210

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Richmond, Virginia, 23298

  • Study site

    Riverside, California, 92501

  • Study site

    Sacramento, California, 95816-5119

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92103-8342

  • Study site

    San Diego, California, 92120

  • Study site

    San Francisco, California, 94117

  • Study site

    San Jose, California, 95116-1906

  • Study site

    Springfield, Massachusetts, 01107

  • Study site

    Stony Brook, New York, 11794-8161

  • Study site

    The Bronx, New York, 10467

  • Study site

    Toledo, Ohio, 43606

  • Study site

    Winston-Salem, North Carolina, 27157-1023

Other trials in United States

Canada9 sites

  • Study site

    Kingston, Ontario, K7L 3N6

  • Study site

    London, Ontario, N6A 5A5

  • Study site

    Mississauga, Ontario, L5M 2V8

  • Study site

    Montreal, Quebec, H3A 1A1

  • Study site

    Saskatoon, Saskatchewan, S7K 1N4

  • Study site

    Scarborough Village, Ontario, M1H 3G4

  • 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

    Aubervilliers, 93307

  • Study site

    Bordeaux, 33076

  • Study site

    La Tronche, 38700

  • Study site

    Paris, 75 016

  • Study site

    Paris, 75015

  • Study site

    Paris, 75651

  • Study site

    Toulouse, 31059

Other trials in France

Germany7 sites

  • Study site

    Dortmund, 44263

  • Study site

    Ellwangen, 73479

  • Study site

    München, 80804

  • Study site

    Nuremberg, 90431

  • Study site

    Stuttgart, 70191

  • Study site

    Wiesbaden, 65191

  • Study site

    Wiesloch, 69168

Other trials in Germany

Italy5 sites

  • Study site

    Como, 22100

  • Study site

    Lecco, 23900

  • Study site

    Lodi, 26900

  • Study site

    Milan, 20162

  • Study site

    Pavia, 27100

Other trials in Italy

Spain5 sites

  • Study site

    A Coruña, 15006

  • Study site

    Barcelona, 08003

  • Study site

    Madrid, 28007

  • Study site

    Málaga, 29010

  • Study site

    Seville, 41013

Other trials in Spain

Norway4 sites

  • Study site

    Bergen, 5021

  • Study site

    Levanger, 7600

  • Study site

    Lillehammer, 2629

  • Study site

    Trondheim, 7006

Other trials in Norway

Switzerland2 sites

  • Study site

    Lausanne, 1003

  • Study site

    Lausanne, 1011

Other trials in Switzerland

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 Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Conditions
Anemia
Being tested
Epoetin alfa or beta, RO0503821 (1x/2 Weeks), RO0503821 (1x/4 Weeks)
Medical subject headings
Anemia

What participants receive

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

  • Epoetin alfa or betaDrug

    Also called Epoetin

    intravenously 3 times weekly for 52 weeks, as prescribed

  • RO0503821 (1x/2 Weeks)Drug

    Also called Mircera

    60, 100, or 180 microgram (mcg) (starting dose) once every two weeks intravenously for 52 weeks.

  • RO0503821 (1x/4 Weeks)Drug

    Also called Mircera

    120, 200 or 360 mcg (starting dose) once every four weeks intravenously for 52 weeks.

Study groups in NCT00077610
Study groupRoleWhat they receive
RO0503821 (1x/2 Weeks)ExperimentalParticipants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 microgram [mcg]) that was based on the Epoetin dose (<8000, 8000-16000, >16000 International units [IU]/Week) administered during the week preceding the switch to the study drug.
Receives: Drug: RO0503821 (1x/2 Weeks)
RO0503821 (1x/4 Weeks)ExperimentalParticipants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
Receives: Drug: RO0503821 (1x/4 Weeks)
Epoetin (1-3x/Weeks)Active comparatorParticipants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
Receives: Drug: Epoetin alfa or beta

What is being measured

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

  1. Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period

    A time adjusted mean change in Hb concentration was calculated using an Area Under the Curve (AUC) approach, for both periods separately. Change in Hb concentration between the Baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb from the average evaluation period Hb. At the end of the Week 36, data allowing the evaluation of the therapeutic response was available for 188 out of 221 eligible participants in RO0503821 (1x/2 Weeks) arm; 172 out of 220 eligible participants in RO0503821 (1x/4 Weeks); and 180 out of 225 participants in Epoetin (1-3x/Weeks) arm.

    Measured: Baseline, Week 29 to Week 36

Secondary outcomes (7)

  1. Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration.

    The mean Hb of all values recorded during the evaluation period were calculated, and were subtracted from the mean baseline Hb for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given.

    Measured: Baseline, Week 29 to Week 36

  2. The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods

    The number of participants who received RBC transfusions during the titration and evaluation periods were reported .

    Measured: Week 1 to Week 36

  3. Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell Counts (WBC) and Red Blood Cells (RBC)

    Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for Platelet was 100-550x10^9/Litre [L], for WBC was 3.0-18.0.0x10^9/L, and for RBC was 3.80-6.10x10^12/L.

    Measured: Up to Week 53

  4. Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes

    Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for aspartate aminotransferase (AST) was 0-80 (unit per litre [U/L]), alanine aminotransferase (ALT) 0-110 U/L, alkaline phosphatase (ALP) 0-220 U/L, albumin >=30.0 gram/litre (g/L), glucose in non-diabetics 2.80-11.10 (millimol/litre [mmol/L]); potassium 2.90-5.80 mmol/L, and phosphorus 0.75-1.60 mmol/L

    Measured: Up to Week 53

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

    Blood pressure was measured by manual assessment or automated reading throughout the entire 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 (SBP) and diastolic (DBP) blood pressures were recorded before dialysis (BD) and after dialysis (AD).

    Measured: Baseline, Week 36 and Week 52

  6. 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 value and a value for specified time period.

    Measured: Baseline, Week 36 and Week 52

  7. Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Death

    An 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. An 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: Upto Week 53

Timeline

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

  1. First posted13 Feb 2004 (estimated)
  2. Study startFeb 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
673 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00077610
Sponsor's protocol ID
BA16739
Status last verified
Sep 2016
First submitted
10 Feb 2004
Last updated
13 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

  • Levin NW, Fishbane S, Canedo FV, Zeig S, Nassar GM, Moran JE, Villa G, Beyer U, Oguey D; MAXIMA study investigators. Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomised non-inferiority trial (MAXIMA). Lancet. 2007 Oct 20;370(9596):1415-21. doi: 10.1016/S0140-6736(07)61599-2.

    PubMed 17950856

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Epoetin alfa or beta, RO0503821 (1x/2 Weeks) and RO0503821 (1x/4 Weeks) in people with Anemia, run by Hoffmann-La Roche at 99 sites in 8 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 13 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 99 sites in United States, Canada, France, Germany, Italy and 3 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 29 Feb 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 (Hb) Concentration From Baseline to Evaluation Period (time frame: Baseline, 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 NCT00077610, 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 13 Jan 2017.

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