STAAR-2 Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00368901
Recruitment Status : Completed
First Posted : August 29, 2006
Last Update Posted : March 5, 2010
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Brief Summary:
To assess the effect of Aranesp on the hemoglobin (Hgb) of CRI subjects who are recombinant human erythropoietin (rHuEPO)-naïve or converting from rHuEPO therapy.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Chronic Renal Insufficiency Kidney Disease Pre-dialysis Pre-ESRD Drug: Darbepoetin alfa Phase 4

Detailed Description:
To assess the effect of Aranesp_ on the hemoglobin (Hgb) of CRI subjects who are recombinant human erythropoietin (rHuEPO)-naïve or converting from rHuEPO therapy. To assess the association between subject self-reported health-related quality of life (HRQoL) as it relates to Hgb concentration and glomerular filtration rate (GFR) in subjects who were rHuEPO-naïve prior to study enrollment. To characterize the health-related resource utilization of subjects with CRI. To characterize the subject satisfaction with Aranesp_ compared to previous rHuEPO therapy. To characterize iron treatment in subjects with CRI. To assess the safety profile of Aranesp_ therapy in subjects with CRI

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 618 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Study Using Once Every Other Week Subcutaneous Administration of Aranesp™ (Darbepoetin Alfa) and Iron Guided Algorithms to Treat Subjects With Anemia of Chronic Renal Insufficiency (CRI)
Study Start Date : January 2002
Actual Primary Completion Date : March 2004
Actual Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Single arm
Every other week dosing of Aranesp SC
Drug: Darbepoetin alfa
Aranesp administered every other week SC titrated to not exceed Hb 12 g/dL
Other Name: Aranesp

Primary Outcome Measures :
  1. Mean hemoglobin during the evaluation period [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Change in hemoglobin throughout the study [ Time Frame: 52 weeks ]
  2. HRQoL scores of rHuEPO-naïve subjects measured at baseline, week 12, week 24, and end of study [ Time Frame: 52 weeks ]
  3. Health-related resource utilization, measured every 4 weeks, throughout the study [ Time Frame: 52 weeks ]
  4. Patient satisfaction scores of subjects previously on rHuEPO therapy, measured at baseline and week 12 [ Time Frame: 12 weeks ]
  5. Iron requirement (dose, frequency, and route) of subjects during the study [ Time Frame: 52 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ≥ 18 years old
  • diagnosis of CRI and not receiving dialysis therapy (must be predialysis)
  • measured or estimated (using the Cockcroft-Gault formula) creatinine clearance (CrCl) of ≤ 70 mL/min, or GFR ≤ 60 mL/min (using the MDRD formula):
  • Cockcroft-Gault formula: CrCl = (140 minus age in years) x (body weight in kg) serum creatinine (mg/dL) x 72.0 For women, the value will be multiplied by 0.85
  • MDRD formula: GFR = 170 x [SCr]-0.999 x [Age]-0.167 x [0.762 if subject is female] x [1.180 if subject is black] x [sun] -0.170SAlb]-0.318
  • mean Hgb < 11 g/dL during the screening/baseline period (if subject is not already receiving rHuEPO therapy)
  • for subjects currently receiving rHuEPO therapy, the subject must have: a stable rHuEPO dose for the past month; and a rHuEPO frequency of once weekly.
  • white blood cell and platelet counts within normal limits
  • serum vitamin B12 and folate levels above the lower limit of normal range
  • transferrin saturation (TSAT) ≥ 20% during the screening period
  • availability for follow-up assessments
  • subject must be able to comprehend and be willing to, or have legally accepted representative, give written informed consent for participation in the study

Exclusion Criteria:

  • scheduled to initiate dialysis
  • uncontrolled hypertension (diastolic blood pressure > 105 mm Hg or systolic blood pressure of > 180 mm Hg during the screening/baseline period on two separate measurements)
  • clinically unstable in the judgment of the investigator (eg, subject is in the intensive care unit, immediately post-myocardial infarction, etc)
  • scheduled to receive a living donor kidney transplant
  • treatment of grand mal epilepsy within the past 6 months
  • moderate to severe congestive heart failure (NYHA class III or IV)
  • clinical evidence of severe secondary hyperparathyroidism (parathyroid hormone level > 1500 pg/mL)
  • severe active chronic inflammatory process (eg, ulcerative colitis, peptic ulcer disease, rheumatoid arthritis, etc)
  • currently receiving antibiotic therapy for systemic infection (enrollment may be postponed until the course of antibiotics has ended)
  • known aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 times the upper limit of the normal range on more than one occasion within three months prior to screening
  • known positive HIV antibody or hepatitis B surface antigen
  • clinical evidence of current malignancy and/or receiving chemotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia
  • active bleeding or RBC transfusion within eight weeks of enrollment
  • androgen therapy within four weeks before enrollment
  • known hematologic disease (eg, sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma; hemolytic anemia, etc)
  • any condition that is likely to affect subject compliance
  • currently or previously (within 30 days) enrolled in investigational device or drug trial(s) or receiving investigational agent(s)
  • the exception to this is if the subject was enrolled in another Aranesp™ or rHuEPO protocol
  • pregnant or breast feeding women (women of child-bearing potential must be using contraceptive precautions)
  • women planning to have a child during the study period
  • known hypersensitivity to the active substance or any of the excipients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00368901

Sponsors and Collaborators
Study Director: MD Amgen

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00368901     History of Changes
Other Study ID Numbers: 20010215
First Posted: August 29, 2006    Key Record Dates
Last Update Posted: March 5, 2010
Last Verified: March 2010

Keywords provided by Amgen:
Kidney Disease
darbepoetin alfa

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Darbepoetin alfa