STAAR-2 Clinical Study

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Darbepoetin alfa

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