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A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00737711
First received: August 18, 2008
Last updated: April 26, 2016
Last verified: April 2016
Results First Received: March 8, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Anemia
Intervention: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

  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
The study was conducted from 08 July 2008 to 31 May 2009 across 16 centers in India. A total of 189 participants were enrolled in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
MIRCERA Participants with chronic renal anemia, on dialysis, received 0.6 microgram per kilogram of body weight (mcg/kg) of Methoxy polyethylene glycol-epoetin beta (MIRCERA/RO0503821), intravenously once every two weeks for 16 weeks. A telephonic / physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.

Participant Flow:   Overall Study
    MIRCERA  
STARTED     189  
COMPLETED     158  
NOT COMPLETED     31  
Adverse Event                 2  
Death                 8  
Failure to return                 4  
Protocol Violation                 1  
Withdrawal by Subject                 5  
Blood transfusion                 6  
Other                 5  



  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.
Safety population included all participants who receive at least one dose of study medication.

Reporting Groups
  Description
MIRCERA Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.

Baseline Measures
    MIRCERA  
Number of Participants  
[units: participants]
  189  
Age  
[units: years]
Mean (Standard Deviation)
  49.74  (14.01)  
Gender  
[units: participants]
 
Female     50  
Male     139  



  Outcome Measures
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1.  Primary:   Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period   [ Time Frame: Baseline (Week 0) and Week 16 ]

2.  Secondary:   Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter   [ Time Frame: Up to Week 16 ]

3.  Secondary:   Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16   [ Time Frame: Week 12 to Week 16 ]

4.  Secondary:   Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16   [ Time Frame: Week 12 to Week 16 ]

5.  Secondary:   Number of Participants With Adverse Events, Serious Adverse Events and Deaths   [ Time Frame: Up to Week 18 ]

6.  Secondary:   Number of Participants With Abnormal Electrocardiogram   [ Time Frame: Up to Week 16 ]

7.  Secondary:   Number of Participants With Reports of Blood Transfusions   [ Time Frame: Up to Week 16 ]

8.  Secondary:   Number of Participants With Reports of Anti-Epoetin Antibodies   [ Time Frame: Up to Week 16 ]

9.  Secondary:   Mean White Blood Cell Count Over Time   [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ]

10.  Secondary:   Mean Value of Mean Corpuscular Volume Over Time   [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ]

11.  Secondary:   Mean Hypochromic Red Blood Cells Over Time   [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ]

12.  Secondary:   Mean Platelet Count Over Time   [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ]

13.  Secondary:   Mean Serum Iron Over Time   [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ]

14.  Secondary:   Mean Serum Ferritin Over Time   [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ]

15.  Secondary:   Mean Transferrin Over Time   [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ]

16.  Secondary:   Mean Total Iron-binding Capacity Over Time   [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ]

17.  Secondary:   Mean Transferrin Saturation Over Time   [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ]

18.  Secondary:   Mean Serum Albumin Over Time   [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ]

19.  Secondary:   Mean Serum Globulin Over Time   [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ]

20.  Secondary:   Mean Serum Creatinine Over Time   [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ]

21.  Secondary:   Mean Blood Urea Nitrogen Over Time   [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ]

22.  Secondary:   Mean Serum Potassium Over Time   [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ]

23.  Secondary:   Mean Serum Sodium Over Time   [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ]

24.  Secondary:   Mean Serum Phosphate Over Time   [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ]

25.  Secondary:   Mean Serum Bilirubin Over Time   [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ]

26.  Secondary:   Mean Aspartate Transaminase Over Time   [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ]

27.  Secondary:   Mean Alanine Aminotransferase Over Time   [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ]

28.  Secondary:   Mean Serum Alkaline Phosphatase Over Time   [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ]


  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: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
phone: +41 616878333
e-mail: global.trial_information@roche.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00737711     History of Changes
Other Study ID Numbers: ML21822
Study First Received: August 18, 2008
Results First Received: March 8, 2016
Last Updated: April 26, 2016
Health Authority: India: Ministry of Health