A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00090753
First received: September 3, 2004
Last updated: February 10, 2012
Last verified: February 2012
Results First Received: December 1, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Anemia
Interventions: Drug: Methoxy Polyethylene Glycol-Epoetin Beta
Drug: Epoetin alfa
Drug: Epoetin beta
Drug: Darbepoetin alfa

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled in one of the following Phase II or Phase III studies: BA16528[NCT00048048], BA16285[NCT00048035], BA16286[NCT00364832], BA16736[NCT00077597], BA16738[NCT00081471], BA16739[NCT00077610], BA16740[NCT00077623], BA17283[NCT00077766] or BA17284[NCT00081484]

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
Methoxy Polyethylene Glycol-Epoetin Beta Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta (Mircera) via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
Comparator ESA Patients received the same comparator erythropoiesis stimulating agent (ESA) [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.

Participant Flow for 2 periods

Period 1:   First Treatment Period
    Methoxy Polyethylene Glycol-Epoetin Beta     Comparator ESA  
STARTED     748     480  
COMPLETED     492     302  
NOT COMPLETED     256     178  
Adverse Event                 20                 8  
Death                 88                 62  
Lack of Efficacy                 2                 1  
Refused Treatment                 32                 25  
Lost to Follow-up                 4                 4  
Renal Transplant                 70                 50  
Mircera Commercialization                 1                 0  
Other Unrelated to Safety and Efficacy                 39                 28  

Period 2:   Extended Treatment Period
    Methoxy Polyethylene Glycol-Epoetin Beta     Comparator ESA  
STARTED     453 [1]   250 [2]
COMPLETED     94     59  
NOT COMPLETED     359     191  
Adverse Event                 11                 0  
Death                 58                 30  
Lack of Efficacy                 1                 0  
Refused Treatment                 18                 12  
Lost to Follow-up                 3                 1  
Renal Transplant                 15                 12  
Mircera Commercialization                 188                 93  
Other Unrelated to Safety and Efficacy                 65                 43  
[1] 39 patients who completed the first treatment period refused to enter the extended treatment period.
[2] 52 patients who completed the first treatment period refused to enter the extended treatment period.



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Methoxy Polyethylene Glycol-Epoetin Beta Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
Comparator ESA Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
Total Total of all reporting groups

Baseline Measures
    Methoxy Polyethylene Glycol-Epoetin Beta     Comparator ESA     Total  
Number of Participants  
[units: participants]
  748     480     1228  
Age  
[units: years]
Mean ± Standard Deviation
  61.2  ± 14.80     61.9  ± 14.42     61.5  ± 14.65  
Gender  
[units: participants]
     
Female     327     223     550  
Male     421     257     678  



  Outcome Measures
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1.  Primary:   Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation   [ Time Frame: Baseline to the end of the study (Up to 49 Months) ]

2.  Secondary:   Percentage of Patients Who Had at Least 1 Adverse Event   [ Time Frame: From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: 800-821-8590


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00090753     History of Changes
Other Study ID Numbers: BH18387
Study First Received: September 3, 2004
Results First Received: December 1, 2011
Last Updated: February 10, 2012
Health Authority: United States: Food and Drug Administration