staar-1 clinical study

Conditions: Chronic Kidney Disease; Chronic Renal Insufficiency; Kidney Disease; Pre-dialysis; Pre-ESRD

Summary: to assess the effect of aranesp on the hemoglobin of cri subjects who are recombinant human erythropoetin (rhuepo)-naïve or converting from rhuepo therapy

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 assess the safety profile of aranesp™ therapy in subjects with cri.

Eligibility 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 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

Keywords: aranesp anemia kidney disease hemoglobin darbepoetin alfa qol