Study to Evaluate Effectiveness of Aranesp®

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Aranesp®

About this trial

This is an interventional treatment trial for Kidney Disease focused on measuring Kidney disease, Renal, CKD (Chronic Kidney Disease), CRI (Chronic Renal Insufficiency), Pre-dialysis, Amgen, Aranesp®, Darbepoetin alfa, QW dosing, Q2W dosing, Q4W dosing, Patient preference, Subject preference

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Subjects must have signed written informed consent - Be on Procrit® QW or Q2W for a minimum of 12 weeks - Must currently be on a stable dose of Procrit® (defined as less than 25% change in Procrit® dose over the 4 week period immediately prior to enrollment, with no missed doses) - Have Hgb 10-12 g/dL for at least 4 weeks prior to study start - Have 15 less than GFR less than 89 mL/min/1.73 m2 - Have serum vitamin B12 and folate levels above the lower limits of normal - Transferrin saturation greater than 20% Exclusion Criteria: - Currently receiving investigational erythropoietic agents - Expected to initiate renal replacement therapy (dialysis or transplantation) within 1 year of study start - Have less than 1 year life expectancy

Sites / Locations

Outcomes

Primary Outcome Measures

Subject preference

Secondary Outcome Measures

Subject productivity and subject selection of Aranesp® or Procrit® therapy in the parallel arm portion and at study conclusion.

Full Information

NCT ID

NCT00117130

First Posted

June 30, 2005

Last Updated

January 20, 2011

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT00117130

Brief Title

Study to Evaluate Effectiveness of Aranesp®

Official Title

Aranesp® Monthly Preference Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Amgen

4. Oversight

5. Study Description

Brief Summary

The purpose of this study was to evaluate subject preference for Aranesp® administered once monthly (i.e., every 4 weeks (Q4W)) or Procrit® administered once weekly (QW).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Disease

Keywords

Kidney disease, Renal, CKD (Chronic Kidney Disease), CRI (Chronic Renal Insufficiency), Pre-dialysis, Amgen, Aranesp®, Darbepoetin alfa, QW dosing, Q2W dosing, Q4W dosing, Patient preference, Subject preference

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Aranesp®

Primary Outcome Measure Information:

Title

Subject preference

Secondary Outcome Measure Information:

Title

Subject productivity and subject selection of Aranesp® or Procrit® therapy in the parallel arm portion and at study conclusion.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: - Subjects must have signed written informed consent - Be on Procrit® QW or Q2W for a minimum of 12 weeks - Must currently be on a stable dose of Procrit® (defined as less than 25% change in Procrit® dose over the 4 week period immediately prior to enrollment, with no missed doses) - Have Hgb 10-12 g/dL for at least 4 weeks prior to study start - Have 15 less than GFR less than 89 mL/min/1.73 m2 - Have serum vitamin B12 and folate levels above the lower limits of normal - Transferrin saturation greater than 20% Exclusion Criteria: - Currently receiving investigational erythropoietic agents - Expected to initiate renal replacement therapy (dialysis or transplantation) within 1 year of study start - Have less than 1 year life expectancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MD

Organizational Affiliation

Amgen

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

URL

http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf

Description

Notice regarding posted summaries of trial results

URL

http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_33_NESP_20020147.pdf

Description

To access clinical trial results information click on this link

URL

http://www.aranesp.com/

Description

FDA-approved Drug Labeling

Kidney Disease

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial