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

November 23, 2016 updated by: Hoffmann-La Roche

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.

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.
673

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

  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
    • Ontario
      • Kingston, Ontario, Canada, K7L 3N6
      • London, Ontario, Canada, N6A 5A5
      • Mississauga, Ontario, Canada, L5M 2V8
      • Scarborough, Ontario, Canada, M1H 3G4
      • Toronto, Ontario, Canada, M5G 2C4
      • Toronto, Ontario, Canada, M9N 1N8
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 1N4
  • France
      • Aubervilliers, France, 93307
      • Bordeaux, France, 33076
      • La Tronche, France, 38700
      • Paris, France, 75 016
      • Paris, France, 75651
      • Paris, France, 75015
      • Toulouse, France, 31059
  • Germany
      • Dortmund, Germany, 44263
      • Ellwangen, Germany, 73479
      • München, Germany, 80804
      • Nürnberg, Germany, 90431
      • Stuttgart, Germany, 70191
      • Wiesbaden, Germany, 65191
      • Wiesloch, Germany, 69168
  • Italy
      • Como, Italy, 22100
      • Lecco, Italy, 23900
      • Lodi, Italy, 26900
      • Milano, Italy, 20162
      • Pavia, Italy, 27100
  • Norway
      • Bergen, Norway, 5021
      • Levanger, Norway, 7600
      • Lillehammer, Norway, 2629
      • Trondheim, Norway, 7006
  • Spain
      • Barcelona, Spain, 08003
      • La Coruna, Spain, 15006
      • Madrid, Spain, 28007
      • Malaga, Spain, 29010
      • Sevilla, Spain, 41013
  • Switzerland
      • Lausanne, Switzerland, 1011
      • Lausanne, Switzerland, 1003
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
      • Mobile, Alabama, United States, 36608
      • Montgomery, Alabama, United States, 36106
    • California
      • Encino, California, United States, 91356
      • Irvine, California, United States, 92868
      • Los Angeles, California, United States, 90095
      • Monterey Park, California, United States, 91754
      • Riverside, California, United States, 92501
      • Sacramento, California, United States, 95816-5119
      • San Diego, California, United States, 92120
      • San Diego, California, United States, 92103-8342
      • San Francisco, California, United States, 94117
      • San Jose, California, United States, 95116-1906
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
      • Denver, Colorado, United States, 80262
      • Lakewood, Colorado, United States, 80260
    • Florida
      • Ocala, Florida, United States, 34471
      • Pembroke Pines, Florida, United States, 33028
    • Georgia
      • Atlanta, Georgia, United States, 30342
      • Augusta, Georgia, United States, 30901
    • Illinois
      • Chicago, Illinois, United States, 60612
      • Maywood, Illinois, United States, 60153
    • Kentucky
      • Louisville, Kentucky, United States, 40202-1718
    • Louisiana
      • Covington, Louisiana, United States, 70433
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
      • Boston, Massachusetts, United States, 02115
      • Springfield, Massachusetts, United States, 01107
    • Michigan
      • Detroit, Michigan, United States, 48202-2689
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
    • New Jersey
      • Paterson, New Jersey, United States, 07503
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • New York
      • Bronx, New York, United States, 10467
      • Brooklyn, New York, United States, 11203
      • Great Neck, New York, United States, 11021
      • Mineola, New York, United States, 11501
      • New York, New York, United States, 10021
      • New York, New York, United States, 10128
      • Stony Brook, New York, United States, 11794-8161
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7155
      • Raleigh, North Carolina, United States, 27609
      • Winston-salem, North Carolina, United States, 27157-1023
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0585
      • Toledo, Ohio, United States, 43606
    • Oregon
      • Portland, Oregon, United States, 97210
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16502
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15261
      • Pittsburgh, Pennsylvania, United States, 15224
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
      • Nashville, Tennessee, United States, 37232
      • Nashville, Tennessee, United States, 37205
    • Texas
      • Austin, Texas, United States, 78705
      • Houston, Texas, United States, 77054
      • Houston, Texas, United States, 77099
      • San Antonio, Texas, United States, 78229
    • Vermont
      • Burlington, Vermont, United States, 05401
    • Virginia
      • Fairfax, Virginia, United States, 22031
      • Richmond, Virginia, United States, 23298
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449

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 renal anemia;
  • on dialysis therapy for at least 12 weeks before screening;
  • receiving IV epoetin for at least 8 weeks before screening.

Exclusion Criteria:

  • 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.

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
  • Masking: NONE

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: RO0503821 (1x/2 Weeks)
Participants 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.
Drug: RO0503821 (1x/2 Weeks)
60, 100, or 180 microgram (mcg) (starting dose) once every two weeks intravenously for 52 weeks.
Other Names:
  • Mircera
EXPERIMENTAL: RO0503821 (1x/4 Weeks)
Participants 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.
Drug: RO0503821 (1x/4 Weeks)
120, 200 or 360 mcg (starting dose) once every four weeks intravenously for 52 weeks.
Other Names:
  • Mircera
ACTIVE_COMPARATOR: Epoetin (1-3x/Weeks)
Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
Drug: Epoetin alfa or beta
intravenously 3 times weekly for 52 weeks, as prescribed
Other Names:
  • Epoetin

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
Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period
Time Frame: Baseline, Week 29 to Week 36
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.
Baseline, Week 29 to Week 36

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
Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration.
Time Frame: Baseline, Week 29 to Week 36
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.
Baseline, Week 29 to Week 36
The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods
Time Frame: Week 1 to Week 36
The number of participants who received RBC transfusions during the titration and evaluation periods were reported .
Week 1 to Week 36
Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell Counts (WBC) and Red Blood Cells (RBC)
Time Frame: Up to Week 53
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.
Up to Week 53
Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes
Time Frame: Up to Week 53
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
Up to Week 53
Mean Change in Blood Pressure From Baseline at Week 36 and Week 52
Time Frame: Baseline, 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).
Baseline, Week 36 and Week 52
Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52
Time Frame: Baseline, 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.
Baseline, Week 36 and Week 52
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Death
Time Frame: Upto Week 53
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.
Upto Week 53

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
February 1, 2004

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, 2005

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, 2005

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).
February 10, 2004

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.
February 12, 2004

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.
February 13, 2004

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.
January 13, 2017

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.
November 23, 2016

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.
September 1, 2016

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.
  • BA16739

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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