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

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

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

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 ]

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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