Phase 2 Study of Darbepoetin Alfa Extended Dosing

NCT00527215 | Completed Phase 2

• 1 other identifier: 20010212
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pre-Dialysis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To assess the safety, toleratbility, and pharmacokinetic (PK) profile of darbepoetin alfa when administered once every 4 weeks.

  Entire study

Study Arms (1)

darbepoetin alfa

EXPERIMENTAL

Drug: darbepoetin alfa

Interventions

darbepoetin alfa DRUG

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

darbepoetin alfa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Receiving renal replacement therapy
• Uncontrolled hypertension
• Hyperparathyroidism
• Major surgery, active inflammatory disease, receiving antibiotics, HIV-positive
• Current malignancy
• Pregnant or breast-feeding

Sponsors & Collaborators

• Amgen: lead

Related Publications (2)

• 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. doi: 10.5414/cnp63327.

  PMID: 15909591 RESULT

• 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. doi: 10.1016/j.jamda.2006.07.007. Epub 2006 Sep 29.

  PMID: 17289537 RESULT

Related Links

• Notice regarding posted summaries of trial results
• To access clinical trial results information click on this link
• FDA-approved Drug Labeling
• AmgenTrials clinical trials website

MeSH Terms

Interventions

Darbepoetin alfa

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 6, 2007
• First Posted: September 10, 2007
• Study Start: March 1, 2002
• Primary Completion: October 1, 2003
• Study Completion: October 1, 2003
• Last Updated: May 22, 2009

Record last verified: 2009-05