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A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)

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ClinicalTrials.gov Identifier: NCT00773513
Recruitment Status : Completed
First Posted : October 16, 2008
Results First Posted : August 15, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Chronic Renal Anemia
Interventions: Drug: Darbepoetin Alfa
Drug: Epoetin Alfa
Drug: Epoetin Beta
Drug: methoxy polyethylene glycol-epoetin beta

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Erythropoiesis Stimulating Agents (ESA) Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
Methoxy Polyethylene Glycol-Epoetin Beta Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.

Participant Flow:   Overall Study
    Erythropoiesis Stimulating Agents (ESA)   Methoxy Polyethylene Glycol-Epoetin Beta
STARTED [1]   1413   1412 
Received Study Treatment   1409   1409 
COMPLETED   312   303 
NOT COMPLETED   1101   1109 
Renal Transplant                254                263 
Adverse Event / Intercurrent Illness                40                48 
Withdrew Consent                68                69 
Refused Treatment / Did not Cooperate                26                32 
Failure to Return                22                8 
Insufficient Therapeutic Response                1                18 
Reason Not Specified                159                126 
Death                531                545 
[1] Randomized with informed consent



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intention-to treat (ITT) population consisted of all participants randomized with the appropriate signed consent documentation.

Reporting Groups
  Description
Erythropoiesis Stimulating Agents Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
Methoxy Polyethylene Glycol-Epoetin Beta Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
Total Total of all reporting groups

Baseline Measures
   Erythropoiesis Stimulating Agents   Methoxy Polyethylene Glycol-Epoetin Beta   Total 
Overall Participants Analyzed 
[Units: Participants]
 1413   1412   2825 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.6  (14.8)   62.2  (15.0)   62.4  (14.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      581  41.1%      605  42.8%      1186  42.0% 
Male      832  58.9%      807  57.2%      1639  58.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White   1221   1218   2439 
Asian   111   119   230 
Black or African American   40   37   77 
Other   41   38   79 


  Outcome Measures

1.  Primary:   Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First   [ Time Frame: Baseline up to approximately 8.5 years ]

2.  Secondary:   Time to All-Cause Mortality   [ Time Frame: Baseline up to approximately 8.5 years ]

3.  Secondary:   Time to Non-Fatal and Fatal Myocardial Infarction   [ Time Frame: Baseline up to approximately 8.5 years ]

4.  Secondary:   Time to Non-Fatal and Fatal Stroke   [ Time Frame: Baseline up to approximately 8.5 years ]

5.  Secondary:   Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurred First)   [ Time Frame: Baseline up to approximately 8.5 years ]

6.  Secondary:   Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA)   [ Time Frame: Baseline up to approximately 8.5 years ]

7.  Secondary:   Percentage of Participants With Gastrointestinal Bleeding   [ Time Frame: Baseline up to approximately 8.5 years ]

8.  Secondary:   Percentage of Participants With Thromboembolic Events   [ Time Frame: Baseline up to approximately 8.5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was designed and powered to formally test only the primary composite outcome measure only.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: (+41) 616878333
e-mail: global.trial_information@roche.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00773513     History of Changes
Other Study ID Numbers: BH21260
2007-005129-31
First Submitted: October 15, 2008
First Posted: October 16, 2008
Results First Submitted: July 18, 2018
Results First Posted: August 15, 2018
Last Update Posted: September 19, 2018