This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00882713
First received: February 17, 2009
Last updated: August 12, 2016
Last verified: August 2016
Results First Received: July 2, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Anemia
Intervention: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

  Participant Flow
  Hide Participant Flow

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 202 participants were enrolled in this study conducted from 12 February 2009 to 25 October 2010 at 28 study sites in Morocco.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 202 participants, 8 participants did not complete the stability verification period (SVP) of 4 weeks. Overall, 194 participants entered dose titration period (DTP) of 16 weeks.

Reporting Groups
  Description
C.E.R.A. Eligible participants were administered continuous erythropoietin receptor activator (C.E.R.A.) intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.

Participant Flow:   Overall Study
    C.E.R.A.
STARTED   194 
COMPLETED   172 
NOT COMPLETED   22 
Adverse Event                2 
Death                3 
Administrative reasons                4 
refused treatment/withdrew consent                4 
Blood transfusion                2 
Insufficient therapeutic response                3 
Failure to return                2 
Other - Reasons                2 



  Baseline Characteristics
  Hide 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.
Safety population included all participants who have been treated with at least one dose of the study drug and a safety follow-up, whether withdrawn prematurely or not.

Reporting Groups
  Description
C.E.R.A. Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.

Baseline Measures
   C.E.R.A. 
Overall Participants Analyzed 
[Units: Participants]
 194 
Age 
[Units: Years]
Median (Full Range)
 51.5 
 (18 to 89) 
Gender 
[Units: Participants]
 
Female   76 
Male   118 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period   [ Time Frame: EEP (Week 17 to Week 24) ]

2.  Secondary:   Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period   [ Time Frame: SVP (Weeks -3, -2, -1) and EEP (Week 17 to Week 24) ]

3.  Secondary:   Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP   [ Time Frame: EEP (Week 17 to Week 24) ]

4.  Secondary:   Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP   [ Time Frame: EEP (Week 17 to Week 24) ]

5.  Secondary:   Number of Participants With Any Adverse Events or Serious Adverse Events   [ Time Frame: Up to Week 52 ]

6.  Secondary:   Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP   [ Time Frame: DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24) ]

7.  Secondary:   Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase   [ Time Frame: Up to Week 52 ]

8.  Secondary:   Mean Hemoglobin Levels Over Time   [ Time Frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 ]

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

10.  Secondary:   Mean Albumin Levels Over Time   [ Time Frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 ]

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

12.  Secondary:   Mean Phosphate and Potassium Levels Over Time   [ Time Frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 ]

13.  Secondary:   Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time   [ Time Frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 ]

14.  Secondary:   Mean C-Reactive Protein Levels Over Time   [ Time Frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 ]

15.  Secondary:   Mean Ferritin Levels Over Time   [ Time Frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 ]

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

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

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

19.  Secondary:   Mean Change From Baseline in Weight Over Time   [ Time Frame: Week 16 and Week 48 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide 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: 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: NCT00882713     History of Changes
Other Study ID Numbers: ML21797
Study First Received: February 17, 2009
Results First Received: July 2, 2016
Last Updated: August 12, 2016