Status:
COMPLETED
STAAR-2 Clinical Study
Lead Sponsor:
Amgen
Conditions:
Chronic Kidney Disease
Chronic Renal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
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 s...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
618 Patients enrolled
Trial Details
Trial ID
NCT00368901
Start Date
January 1 2002
End Date
May 1 2004
Last Update
March 5 2010
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