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NCT00093977 Clinical Trial

Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00093977
Other study ID # 20040180
Secondary ID
Status Completed
Phase Phase 3
First received October 7, 2004
Last updated May 22, 2013
Start date October 2004
Est. completion date January 2007

Study information
Verified date May 2013
Source Amgen
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1100
Est. completion date January 2007
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Currently diagnosed with Chronic Kidney Disease, either receiving or not receiving dialysis

- Anemic

- Currently on erythropoietic therapy

- Controlled hypertension

- Clinically stable

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Amgen

References & 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 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary To characterize laboratory parameters in subjects with CKD Entire Study Yes
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