NCT00112008

Brief Summary

The proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in CKD patients not on dialysis. Anemic patients who are not currently receiving ESA therapy will be dosed with darbepoetin alfa Q2W for 18 weeks.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2004

Shorter than P25 for phase_3

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

May 1, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2005

Completed
Last Updated

July 10, 2009

Status Verified

July 1, 2009

Enrollment Period

10 months

First QC Date

May 27, 2005

Last Update Submit

July 9, 2009

Conditions

Chronic Kidney DiseaseKidney Disease

Keywords

Anemia

Outcome Measures

Primary Outcomes (1)

  • The proportion of subjects achieving a Hb ≥ 11.0 g/dL

    Entire Study

Secondary Outcomes (3)

  • Hb values over the duration of the study

    Entire Study

  • Darbepoetin alfa doses over the duration of the study

    Entire Study

  • Frequency, severity, and relationship to treatment for adverse events and changes in laboratory parameters and blood pressure

    Entire Study

Study Arms (1)

darbepoetin alfa

EXPERIMENTAL
Drug: De Novo Administration of Darbepoetin Alfa

Interventions

De Novo Administration of Darbepoetin AlfaDRUG

Administration Q2W for 18 weeks. starting dose is 0.75 mcg/kg rounded to the nearest dose: 20, 30, 40, 50, 60, 80, 100, 150, 200 0r 300 mcg. Titrate to maintain Hb within 11.0 - 13.0 g/dL

darbepoetin alfa

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Silver MR, Geronemus R, Krause M, Chen CY, Kewalramani R, Stehman-Breen C. Anemia treatment with Q2W darbepoetin alfa in patients with chronic kidney disease naive to erythropoiesis-stimulating agents. Curr Med Res Opin. 2009 Jan;25(1):123-31. doi: 10.1185/03007990802594818.

    PMID: 19210145RESULT

Related Links

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney DiseasesAnemia

Condition Hierarchy (Ancestors)

Renal InsufficiencyUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic 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

Study Record Dates

First Submitted

May 27, 2005

First Posted

May 30, 2005

Study Start

May 1, 2004

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

July 10, 2009

Record last verified: 2009-07