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

December 13, 2011 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
228

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia, SA 5000
      • Gosford, Australia, 2250
      • Lismore, Australia, 2480
      • Reservoir, Australia, 3073
      • Richmond, Australia, 3121
  • Belgium
      • Aalst, Belgium, 9300
      • Roeselare, Belgium, 8800
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
    • Newfoundland and Labrador
      • St John's, Newfoundland and Labrador, Canada, A1B 3V6
    • Ontario
      • Kingston, Ontario, Canada, K7L 3N6
      • Mississauga, Ontario, Canada, L5M 2V8
      • Toronto, Ontario, Canada, M5G 2C4
      • Toronto, Ontario, Canada, M9N 1N8
    • Quebec
      • Montreal, Quebec, Canada, H2X 3J4
  • Czech Republic
      • Marianske Lazne, Czech Republic, 35301
      • Praha, Czech Republic, 14021
      • Praha 2, Czech Republic, 128 08
      • Praha 4, Czech Republic, 14200
  • France
      • La Tronche, France, 38700
      • Nantes, France, 44035
      • Orleans, France, 45100
      • Paris, France, 75475
      • Rennes, France, 35033
      • St Priest En Jarez, France, 42277
      • Strasbourg, France, 67091
  • Germany
      • Bad Hersfeld, Germany, 36251
      • Bad König, Germany, 64732
      • Berlin, Germany, 13353
      • Bonn, Germany, 53127
      • Coburg, Germany, 96450
      • Demmin, Germany, 17109
      • Dortmund, Germany, 44263
      • München, Germany, 80331
  • Hungary
      • Baja, Hungary, 6500
      • Budapest, Hungary, 1071
      • Esztergom, Hungary, 2500
      • Hodmezovasarhely, Hungary, 6800
      • Kalocsa, Hungary, 6300
      • Kecskemet, Hungary, 6001
      • Szigetvar, Hungary, 7390
      • VAC, Hungary, 2600
  • Israel
      • Hadera, Israel, 38100
      • Jerusalem, Israel, 91031
      • Kfar Saba, Israel, 44281
      • Nahariya, Israel, 22100
      • Rehovot, Israel, 76100
  • Italy
      • Brescia, Italy, 25123
      • Chieti, Italy, 66013
      • Ferrara, Italy, 44100
      • Genova, Italy, 16132
      • La Spezia, Italy, 19124
      • Lecco, Italy, 23900
      • Lodi, Italy, 26900
      • Palermo, Italy, 90127
      • Pavia, Italy, 27100
      • Prato, Italy, 50047
      • Roma, Italy, 00186
      • S Fermo Della Battaglia, Italy, 22020
  • Poland
      • Gdansk, Poland, 80-211
      • Katowice, Poland, 40-027
      • Lodz, Poland, 90-153
      • Radom, Poland, 20-610
      • Rzeszow, Poland, 35-055
      • Sieradz, Poland, 98-200
      • Szczecin, Poland, 70-111
      • Warszawa, Poland, 02-006
  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08025
      • Ciudad Real, Spain, 13005
      • Hospitalet de Llobregat, Spain, 08907
      • La Coruna, Spain, 15006
      • Lerida, Spain, 25198
      • Madrid, Spain, 28007
      • Málaga, Spain, 29010
      • Partida La Ceñuela. Torreviej, Spain, 03186
  • United Kingdom
      • Belfast, United Kingdom, BT9 7LJ
      • Birmingham, United Kingdom, B15 2TH
      • Bradford, United Kingdom, BD5 0NA
      • Exeter, United Kingdom, EX2 5DW
  • United States
    • California
      • Granada Hills, California, United States, 91344
    • Florida
      • Lauderdale Lakes, Florida, United States, 33313
    • Georgia
      • Augusta, Georgia, United States, 30309
    • New York
      • Mineola, New York, United States, 11501
      • Orchard Park, New York, United States, 14127
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
    • Oregon
      • Oregon City, Oregon, United States, 97045
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
    • Virginia
      • Salem, Virginia, United States, 24153
    • West Virginia
      • Morgantown, West Virginia, United States, 26506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mircera
Participants 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.
Drug: Mircera
Starting dose of 120, 200 and 360 micrograms administered by subcutaneous injection once a month.
Other Names:
  • Methoxy polyethylene glycol-epoetin beta
  • RO0503821
Active Comparator: Darbepoetin alfa
Participants 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).
Drug: Darbepoetin alfa
As prescribed, subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling specifications.
Other Names:
  • Aranesp®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin Concentration From Baseline Over Time
Time Frame: From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit.
From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit.
Number of Participants With Red Blood Cell (RBC) Transfusions
Time Frame: From randomization to Month 9
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.
From randomization to Month 9
Participants With Adverse Events
Time Frame: Randomization to Month 10 (final visit)
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.
Randomization to Month 10 (final visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BH20051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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