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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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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



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