STAAR-3 Clinical Study

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00369733
First received: August 24, 2006
Last updated: February 18, 2010
Last verified: February 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: Disease/Case Management of Patients Receiving ARANESP™ (Darbepoetin Alfa) to Treat the 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: 443
Study Start Date: May 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
Aranesp adminsitered every other week for 52 weeks
Drug: Darbepoetin alfa
Darbepoetin alfa adminstered SC every other week to acheive a Hb not to exceed 12 g/dL
Other Name: Aranesp

Detailed Description:

To assess the effect of Aranesp on the hemoglobin of CRI subjectswho are recombinant human erythropoetin (rHuEPO)-naïve or converting from rHuEPO therapy and 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 evaluate the extent to which implementation of case management contributes to achieving the desired clinical objectives.

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:

  • 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]-0.170 x [SAlb]-0.318
  • (if subject is not already receiving rHuEPO therapy) mean Hgb < 11 g/dL during the screening/baseline period
  • 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 aminitransferase (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369733

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: NCT00369733     History of Changes
Other Study ID Numbers: 20010243
Study First Received: August 24, 2006
Last Updated: February 18, 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
Renal Insufficiency, Chronic
Urologic Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014