NCT00096915

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2004

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2004

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

May 22, 2009

Status Verified

May 1, 2009

Enrollment Period

1.1 years

First QC Date

November 17, 2004

Last Update Submit

May 21, 2009

Conditions

Kidney DiseaseChronic Kidney Disease

Keywords

chronic kidney disease, CKDrenal failureanemiahemodialysisperitoneal dialysisAranesp®, Darbepoetin Alfa

Outcome Measures

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

    entire study

Secondary Outcomes (3)

  • Hb values over the duration of the study

    entire study

  • Darbepoetin alfa doses over the duration of the study

    entire study

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

    entire study

Study Arms (1)

darbepoetin alfa

EXPERIMENTAL
Drug: Darbepoetin Alfa

Interventions

Darbepoetin AlfaDRUG

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

darbepoetin alfa

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Kidney DiseasesRenal Insufficiency, ChronicRenal InsufficiencyAnemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 17, 2004

First Posted

November 18, 2004

Study Start

October 1, 2004

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

May 22, 2009

Record last verified: 2009-05