NCT00093977

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 11, 2004

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

May 24, 2013

Status Verified

May 1, 2013

Enrollment Period

2.3 years

First QC Date

October 7, 2004

Last Update Submit

May 22, 2013

Conditions

Kidney DiseaseChronic Kidney Disease

Keywords

Chronic Kidney DiseaseDialysisAnemiaNephrology

Outcome Measures

Primary Outcomes (1)

  • 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

    Entire Study

Secondary Outcomes (1)

  • To characterize laboratory parameters in subjects with CKD

    Entire Study

Study Arms (1)

darbepoetin alfa SF

EXPERIMENTAL
Drug: darbepoetin alfa SF

Interventions

darbepoetin alfa SFDRUG

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

darbepoetin alfa SF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease. J Manag Care Pharm. 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741.

    PMID: 19954265RESULT

Related Links

MeSH Terms

Conditions

Kidney DiseasesRenal Insufficiency, ChronicAnemia

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal InsufficiencyChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2004

First Posted

October 11, 2004

Study Start

October 1, 2004

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

May 24, 2013

Record last verified: 2013-05