Fixed Dose NESP Study in Subjects With CRI

Amgen

Status and phase: Completed; Phase 2

Conditions: Pre-Dialysis

Treatments: Drug: darbepoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00526929

990151

Details and patient eligibility

About

Multicenter, open-label, single-arm, fixed dose study of darbepoetin alfa in subjects with Chronic Renal Insufficiency (CRI). Subjects will be screened for 2 weeks during which time blood will be drawn and vital signs will be taken. Upon enrollment, subjects will receive SC darbepoetin alfa administered once every other week for 24 weeks. Darbepoetin alfa will be titrated in fixed-dose steps to maintain a hemoglobin of 11.0 - 13.0. During the study, laboratory assessments will be completed and vital signs will be taken. Subjects will enter a 1-week post-treatment observation and evaluation period after the last dose of study drug.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Greater than or equal to 18 years of age
• CRI with a creatinine clearance of less than 40 mL/min
• Hemoglobin less than 11.0 g/dL
• Serum vitamin B12 and folate levels above the lower limit of normal and iron replete

Exclusion criteria

• Received rHuEPO therapy in the last 12 weeks
• Expected to initiate renal replacement therapy within 24 weeks or a recipient of a renal transplant
• Uncontrolled hypertension
• Seizure activity, CHF, hyperparathyroidism, major surgery, HIV-positive Pregnant or breast-feeding

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

darbepoetin alfa

Experimental group

Description:

darbepoetin alfa (NESP)

Treatment:

Drug: darbepoetin alfa