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CompletedNCT00096915Updated May 22, 2009

Study Evaluating Darbepoetin Alfa in Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis

A Phase 3 interventional study of Darbepoetin Alfa in Kidney Disease and Chronic Kidney Disease, sponsored by Amgen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-05-22.

Sponsored by Amgen · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
110
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in CKD patients on dialysis. Anemic patients on hemo and peritoneal dialysis who have achieved and maintained target hemoglobin (Hb) on every other week (Q2W) dosing of darbepoetin alfa will have the dosing interval extended to once monthly (QM) dosing.

02

Conditions studied

  • Kidney Disease
  • Chronic Kidney Disease

Keywords

  • chronic kidney disease, CKD
  • renal failure
  • anemia
  • hemodialysis
  • peritoneal dialysis
  • Aranesp®, Darbepoetin Alfa
03

In context

Kidney Diseases

3,843 studies on the registry are indexed under Kidney Diseases; 492 are open to participants now.

This study's enrollment of 110 is above the median of 70 across 2,645 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Amgen is the lead sponsor of 1,044 studies on the registry; 51 are open to participants now.

Of its 246 completed or terminated interventional studies of FDA-regulated products, 164 (67%) have results posted.

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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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of chronic kidney disease (CKD) and receiving dialysis for > 3 months before enrollment
  • Clinically stable, in the judgment of the investigator
  • Mean Hb > 11.0 g/dL (110 g/L) to \< 13.0 g/dL (130 g/L)
  • Transferrin saturation (Tsat) > 19.5%
  • Serum vitamin B12 and folate levels above the lower limit of the normal range
  • Receiving stable Q2W IV or SC doses of Aranesp® (darbepoetin alfa). A stable dose is defined as less than or equal to 25% change in dose over the 6-week period immediately prior to enrollment and with no missed doses in this period

Exclusion criteria

Exclusion Criteria:

  • Scheduled to receive a kidney transplant
  • Diastolic blood pressure greater than 110 mm Hg or systolic BP greater than 180 mm Hg during screening
  • Acute myocardial ischemia
  • Hospitalization for congestive heart failure, myocardial infarction, deep vein thrombosis, stroke or transient ischemic attack within 12 weeks before enrollment
  • Parathyroid hormone (PTH) level greater than 1500 pg/mL (158.0 pmol/L)
  • Major surgery within 12 weeks before enrollment (excluding vascular access surgery)
  • Currently receiving antibiotic therapy for systemic infection
  • Known positive HIV antibody or positive hepatitis B surface antigen
  • Clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia
  • Red blood cell (RBC) transfusions within 8 weeks before enrollment
  • Androgen therapy within 8 weeks before enrollment - Systemic hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia)
  • Any disorder that may impact (in the judgment of the investigator) the ability to give informed consent for participation in this study
  • Pregnant or breast-feeding women
  • All subjects must practice adequate contraception (in the judgment of the investigator) throughout this trial
  • Treatment with an investigational agent or device within 30 days before enrollment or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    darbepoetin alfa

    Drug: Darbepoetin Alfa

Interventions

  • DrugDarbepoetin Alfa

    QM administration for 32 weeks, allowable doses: 15, 20, 30, 40, 50, 60, 80, 100, 150, 200, 300, 400, 500, 600 and 800 mcg

06

What researchers measure

Primary outcomes

  1. The proportion of subjects on QM darbepoetin alfa dosing maintained with a mean Hb greater than or equal to 11.0 g/dL and less than or equal to 13.0 g/dL during the evaluation phase

    Time frame: entire study

Secondary outcomes

  1. Hb values over the duration of the study

    Time frame: entire study

  2. Darbepoetin alfa doses over the duration of the study

    Time frame: entire study

  3. Frequency and relationship to treatment for adverse events and changes in laboratory parameters and blood pressure

    Time frame: entire study

07

Study locations

No study locations are listed for this record.

08

References and documents

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2004, a primary completion of Nov 2005 and a completion of Nov 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2004
First posted
Nov 18, 2004
Start
Oct 2004
Primary completionActual
Nov 2005
CompletionActual
Nov 2005
Last update
May 22, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
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 ↗
10

Registry details

Key details

Study ID
NCT00096915
Lead sponsor
Amgen
First posted
Nov 18, 2004
Start date
Oct 2004
Primary completion
Nov 2005
Completion
Nov 2005
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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