Overview

STAAR-1 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 of CRI subjects who are recombinant human erythropoetin (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 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