Phase 2 Study of Darbepoetin Alfa Extended Dosing

Pre-Dialysis Clinical Trial

Official title:

A Study of Darbepoetin Alfa Administered Once Every Four Weeks in Chronic Renal Insufficiency (CRI) Subjects With Anemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00527215
• Other study ID #: 20010212
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2007
• Last updated: May 21, 2009
• Start date: March 2002
• Est. completion date: October 2003

Study information

• Verified date: May 2009
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Multicenter, open label single arm study in which 140 subjects with CRI who are currently receiving SC darbepoetin alfa once every other week will receive darbepoetin alfa once every 4 weeks for 24 weeks. Upon enrollment into this study, subjects will receive darbepoetin alfa once every 4 weeks for 24 weeks. The initial dose will be equivalent to the subject's total dose in the month preceding enrollment. Doses may be titrated to maintain the Hb concentration in the target range.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: October 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Greater than or equal to 18 years of age

• CRI with a creatinine clearance of greater than 15 but less than 40 mL/min

• Stable once every other week darbepoetin alfa SC for at least 6 weeks

• Hb values during screening / baseline of 10.0 - 12.0 g/dL

• Serum B12 and folate levels above the lower limit of normal and iron replete

Exclusion Criteria:

• Receiving renal replacement therapy

• Uncontrolled hypertension

• Hyperparathyroidism

• Major surgery, active inflammatory disease, receiving antibiotics, HIV-positive

• Current malignancy

• Pregnant or breast-feeding

Study Design

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

Related Conditions & MeSH terms

• Pre-Dialysis

Intervention

Drug:
• darbepoetin alfa
starting dose determined by calculating a subject's total dose in the month preceding enrollment. Administered QM for 25 weeks. Change made as necessary to maintain a hemoglobin concentration within the target range os 10.0 - 12.0 g.dL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (2)

Agarwal A, Silver MR, Walczyk M, Liu W, Audhya P. Once-monthly darbepoetin alfa for maintaining hemoglobin levels in older patients with chronic kidney disease. J Am Med Dir Assoc. 2007 Feb;8(2):83-90. Epub 2006 Sep 29. — View Citation

Ling B, Walczyk M, Agarwal A, Carroll W, Liu W, Brenner R. Darbepoetin alfa administered once monthly maintains hemoglobin concentrations in patients with chronic kidney disease. Clin Nephrol. 2005 May;63(5):327-34. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the proportion of CRI subjects maintaining a target hemoglobin (Hb) range of 10.0 to 12.0 g/dL when administered subcutaneous (SC) darbepoetin alfa once every 4 weeks		Study weeks 21 - 29	No
Secondary	To assess the safety, toleratbility, and pharmacokinetic (PK) profile of darbepoetin alfa when administered once every 4 weeks.		Entire study	Yes

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling