STAAR-2 Clinical Study

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00368901
First received: August 24, 2006
Last updated: March 4, 2010
Last verified: March 2010
  Purpose

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 Intervention Phase
Chronic Kidney Disease
Chronic Renal Insufficiency
Kidney Disease
Pre-dialysis
Pre-ESRD
Drug: Darbepoetin alfa
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Mean hemoglobin during the evaluation period [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in hemoglobin throughout the study [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • HRQoL scores of rHuEPO-naïve subjects measured at baseline, week 12, week 24, and end of study [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Health-related resource utilization, measured every 4 weeks, throughout the study [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Patient satisfaction scores of subjects previously on rHuEPO therapy, measured at baseline and week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Iron requirement (dose, frequency, and route) of subjects during the study [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 618
Study Start Date: January 2002
Study Completion Date: May 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00368901

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00368901     History of Changes
Other Study ID Numbers: 20010215
Study First Received: August 24, 2006
Last Updated: March 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Aranesp
Anemia
Kidney Disease
Hemoglobin
darbepoetin alfa
QoL

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014