A Study of the Use of PROCRIT (Epoetin Alfa) for the Treatment of Anemia in People With Chronic Kidney Disease Who Live in Long-term Care Facilities.

This study has been completed.

Sponsor:

Collaborator:

Ortho Biotech Clinical Affairs, L.L.C.

Information provided by (Responsible Party):

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

ClinicalTrials.gov Identifier:

NCT00337935

First received: June 16, 2006

Last updated: May 7, 2013

Last verified: May 2013

History of Changes

Results First Received: July 16, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Factorial Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Renal Failure , Chronic Anemia
Interventions:	Drug: Epoetin Alfa Other: Standard of care

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
Standard of Care	Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
PROCRIT (Epoetin Alfa)	epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks

Participant Flow: Overall Study

	Standard of Care	PROCRIT (Epoetin Alfa)
STARTED	39	118
COMPLETED	29	91
NOT COMPLETED	10	27
Adverse Event	2	5
Death	2	8
Physician Decision	1	1
Lost to Follow-up	0	1
Protocol Violation	4	3
Withdrawal by Subject	1	7
Unknown	0	1
Lack of Efficacy	0	1

Baseline Characteristics

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Reporting Groups

	Description
Standard of Care	Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
PROCRIT (Epoetin Alfa)	epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
Total	Total of all reporting groups

Baseline Measures

	Standard of Care	PROCRIT (Epoetin Alfa)	Total
Number of Participants [units: participants]	39	118	157
Age [units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	2	4	6
>=65 years	37	114	151
Age [units: Years] Mean ± Standard Deviation	84.4 ± 10.9	84.1 ± 9.2	84.1 ± 9.6
Gender [units: participants]
Female	33	90	123
Male	6	28	34

Outcome Measures

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1. Primary:

Mean Change in Hemoglobin Level From Baseline to the End of Study (26 Weeks) [ Time Frame: Week 0 to Week 26 ]

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2. Secondary:

The Number of Patients Achieved a Hemoglobin Response. [ Time Frame: Week 0 to Week 26 ]

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3. Secondary:

Time to Hemoglobin Response [ Time Frame: Week 0 to Week 26 ]

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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:

All Principal Investigators ARE employed by the organization sponsoring the study.

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
Upper 95% confidence limit for the Standard of Care Group was not estimable because an insufficient number of participates reached the event at the final time point for assessment.

Results Point of Contact:

Name/Title: Vice President, Medical Affairs
Organization: Centocor Ortho-Biotech LLC.
phone: 800.457.6399

No publications provided

Responsible Party:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00337935 History of Changes
Other Study ID Numbers:	CR012229
Study First Received:	June 16, 2006
Results First Received:	July 16, 2010
Last Updated:	May 7, 2013
Health Authority:	United States: Food and Drug Administration

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