A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

This study has been terminated.

(Strategic decision unrelated to safety or efficacy)

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00422513

First received: January 15, 2007

Last updated: November 9, 2011

Last verified: November 2011

History of Changes

Results First Received: March 29, 2011

Study Type:	Interventional
Study Design:	Allocation: 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

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
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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
Methoxy Polyethylene Glycol-epoetin Beta	120-360 micrograms intravenous (iv) monthly, starting dose
Epoetin Alfa	As prescribed, (iv), 3 times weekly

Participant Flow: Overall Study

	Methoxy Polyethylene Glycol-epoetin Beta	Epoetin Alfa
STARTED	130	130
COMPLETED	23	24
NOT COMPLETED	107	106
Lack of Efficacy	4	5
Protocol Violation	23	7
Refused Treatment	4	2
Withdrawal by Subject	2	1
early termination of the study	67	80
Adverse Event	4	4
Death	3	7

Baseline Characteristics

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Reporting Groups

	Description
Methoxy Polyethylene Glycol-epoetin Beta	120-360 micrograms (iv) monthly, starting dose
Epoetin Alfa	As prescribed, (iv), 3 times weekly
Total	Total of all reporting groups

Baseline Measures

	Methoxy Polyethylene Glycol-epoetin Beta	Epoetin Alfa	Total
Number of Participants [units: participants]	123	129	252
Age ^[1] [units: years] Mean ± Standard Deviation	59.3 ± 13.90	60.0 ± 14.06	59.7 ± 13.96
Gender [units: participants]
Female	52	60	112
Male	71	69	140

[1]	Eight patients were excluded from the safety population: 7 patients in the Methoxy Polyethylene Glycol-epoetin Beta group and 1 patient in the epoetin alfa group. Six patients in the Methoxy Polyethylene Glycol-epoetin Beta group did not receive study medication. Seven patients in the Methoxy Polyethylene Glycol-epoetin Beta group and 1 patient in the epoetin alfa group did not have a postbaseline safety assessment.

[1]

Eight patients were excluded from the safety population: 7 patients in the Methoxy Polyethylene Glycol-epoetin Beta group and 1 patient in the epoetin alfa group. Six patients in the Methoxy Polyethylene Glycol-epoetin Beta group did not receive study medication. Seven patients in the Methoxy Polyethylene Glycol-epoetin Beta group and 1 patient in the epoetin alfa group did not have a postbaseline safety assessment.

Outcome Measures

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1. Primary:

Time Spent on Anemia Treatment Over Evaluation Period [ Time Frame: Months 5-7 ]

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2. Primary:

Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period [ Time Frame: Baseline, Months 5-7 ]

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3. Secondary:

Number of Participants Assessed for AEs [ Time Frame: Month 1 to 15 day follow up post month 7 ]

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4. Secondary:

The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants [ Time Frame: Baseline, Month 1 to Month 7 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights

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
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Results Point of Contact:

Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00422513 History of Changes
Other Study ID Numbers:	ML20336
Study First Received:	January 15, 2007
Results First Received:	March 29, 2011
Last Updated:	November 9, 2011
Health Authority:	United States: Food and Drug Administration

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