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CompletedNCT00527215Updated May 22, 2009

Phase 2 Study of Darbepoetin Alfa Extended Dosing

A Phase 2 interventional study of darbepoetin alfa in Pre-Dialysis, sponsored by Amgen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-05-22.

Sponsored by Amgen · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
98
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Pre-Dialysis
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In context

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Receiving renal replacement therapy
  • Uncontrolled hypertension
  • Hyperparathyroidism
  • Major surgery, active inflammatory disease, receiving antibiotics, HIV-positive
  • Current malignancy
  • Pregnant or breast-feeding
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
98 participants (actual)

Study arms

  • Experimental
    darbepoetin alfa

    Drug: darbepoetin alfa

Interventions

  • Drugdarbepoetin 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

06

What researchers measure

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

    Time frame: 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.

    Time frame: Entire study

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 15909591 ↗
  • 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. PubMed 17289537 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00527215
Lead sponsor
Amgen
First posted
Sep 10, 2007
Start date
Mar 2002
Primary completion
Oct 2003
Completion
Oct 2003
Last update
May 22, 2009

Study contacts

MD
study director · Amgen
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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