Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00093977

Purpose

The purpose of this study is to determine whether darbepoetin alfa manufactured by the current "roller bottle" technology and darbepoetin alfa manufactured by a serum free process have a comparable safety profile.

Condition	Intervention	Phase
Kidney Disease Chronic Kidney Disease	Drug: darbepoetin alfa SF	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	An Open-Label, Single-Arm Study to Assess the Safety of Darbepoetin Alfa Manufactured by a Serum Free Bioreactor Technology in Subjects With Chronic Kidney Disease

Resource links provided by NLM:

Drug Information available for: Darbepoetin alfa

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

To determine whether darbepoetin alfa manufactured by a roler bottle technology (darbepoetin alfa RB) and darbepoetin alfa manufactured by a serum free process (darbepoetin alfa SF) have a comparable safety profile [ Time Frame: Entire Study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To characterize laboratory parameters in subjects with CKD [ Time Frame: Entire Study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1100
Study Start Date:	October 2004
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
darbepoetin alfa SF: Experimental	Drug: darbepoetin alfa SF Frequency of dosing depends on frequency at randomization: rHuEPO QW = darbepoetin alfa SF Q2W (dosing conversion table in protocol) rHuEPO biw or tiw = darbepoetin alfa SF QW (dosing conversion table in protocol) darbepoetin alfa RB = darbepoetin alfa SF at same dose and frequency PFS 10, 15, 20, 30, 40, 50, 60, 80, 100, 150, 200 or 300 mcg; Hb maintained between 11.0 - 13.0 g/dL

Arms

Assigned Interventions

darbepoetin alfa SF: Experimental

Drug: darbepoetin alfa SF

Frequency of dosing depends on frequency at randomization:

rHuEPO QW = darbepoetin alfa SF Q2W (dosing conversion table in protocol) rHuEPO biw or tiw = darbepoetin alfa SF QW (dosing conversion table in protocol) darbepoetin alfa RB = darbepoetin alfa SF at same dose and frequency PFS 10, 15, 20, 30, 40, 50, 60, 80, 100, 150, 200 or 300 mcg; Hb maintained between 11.0 - 13.0 g/dL

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Currently diagnosed with Chronic Kidney Disease, either receiving or not receiving dialysis
Anemic
Currently on erythropoietic therapy
Controlled hypertension
Clinically stable

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093977

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20040180
Study First Received:	October 7, 2004
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00093977 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Chronic Kidney Disease
Dialysis
Anemia
Nephrology

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Hematinics
Renal Insufficiency, Chronic
Darbepoetin alfa

Anemia
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Hematinics
Renal Insufficiency, Chronic
Therapeutic Uses
Hematologic Agents

Darbepoetin alfa
Kidney Failure, Chronic
Kidney Diseases
Pharmacologic Actions
Kidney Failure

ClinicalTrials.gov processed this record on August 13, 2009