A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00661388
First received: April 16, 2008
Last updated: June 9, 2016
Last verified: June 2016
Results First Received: June 9, 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
A total of 75 participants were enrolled in this study conducted from 12 August 2008 to December 2010 at 9 centers in Turkey.

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
C.E.R.A Eligible participants were administered continuous erythropoietin receptor activator (C.E.R.A) subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 micrograms (mcg)/kilogram (kg). Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) within the target range of 10.0 and 12.0 grams (g)/ deciliter (dL).

Participant Flow:   Overall Study
    C.E.R.A  
STARTED     75  
COMPLETED     51  
NOT COMPLETED     24  
Adverse Event                 14  
Protocol Violation                 7  
Renal transplantation                 1  
Dialysis initiation                 1  
Administrative reasons                 1  



  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all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not.

Reporting Groups
  Description
C.E.R.A Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.

Baseline Measures
    C.E.R.A  
Number of Participants  
[units: participants]
  75  
Age  
[units: years]
Mean (Standard Deviation)
  52.8  (16.36)  
Gender  
[units: Participants]
 
Female     57  
Male     18  



  Outcome Measures
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1.  Primary:   Mean Change in Hb Concentration Between Baseline and the Efficacy Evaluation Period   [ Time Frame: From Baseline (Week 0) to EEP (Week 29 to Week 36) ]

2.  Secondary:   Mean Time to Achievement of Response During the EEP   [ Time Frame: From Week 29 to Week 36 ]

3.  Secondary:   The Percentage of Participants Whose Hb Concentrations Remained Within the Target Range of 10.0- 12.0 g/dLThroughout the EEP   [ Time Frame: From Week 29 to Week 36 ]

4.  Secondary:   Mean Time Spent by Participants in the Target Range of 10.0- 12.0 g/dL During the EEP   [ Time Frame: From Week 29 to Week 36 ]

5.  Secondary:   Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP   [ Time Frame: Weeks 0 to Week 36 ]

6.  Secondary:   Number of Red Blood Cell Transfusions During the Study Period   [ Time Frame: Up to Week 52 ]

7.  Secondary:   Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events   [ Time Frame: Up to Week 52 ]

8.  Secondary:   Mean Change From Baseline in Hb Concentration Over Time   [ Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48 ]

9.  Secondary:   Mean Change From Baseline in Hematocrit Level Over Time   [ Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48 ]

10.  Secondary:   Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Over Time   [ Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, and 48 ]

11.  Secondary:   Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time   [ Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48 ]

12.  Secondary:   Mean Change From Baseline in Albumin Concentration Over Time   [ Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48 ]

13.  Secondary:   Mean Change From Baseline in C-Reactive Protein Concentration Over Time   [ Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48 ]

14.  Secondary:   Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time   [ Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48 ]

15.  Secondary:   Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time   [ Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48 ]

16.  Secondary:   Mean Change From Baseline in Creatinine Concentration Over Time   [ Time Frame: Baseline (Week 0), Weeks 8, 16, 32, 40 ]

17.  Secondary:   Mean Change From Baseline in Ferritin Concentration Over Time   [ Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48 ]

18.  Secondary:   Mean Change From Baseline in Transferrin Saturation Over Time   [ Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48 ]


  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 61 6878333
e-mail: global.trial_information@roche.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00661388     History of Changes
Other Study ID Numbers: ML21524
Study First Received: April 16, 2008
Results First Received: June 9, 2016
Last Updated: June 9, 2016
Health Authority: Turkey: Ministry of Health