Fixed Dose NESP Study in Subjects With CRI

Pre-Dialysis Clinical Trial

Official title:

A Pilot Study Evaluating Once Every Other Week Administration of Fixed Doses of Novel Erythropoiesis Stimulating Protein (NESP) to Subjects With Chronic Renal Insufficiency (CRI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00526929
• Other study ID #: 990151
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2007
• Last updated: May 21, 2009
• Start date: May 2000
• Est. completion date: February 2002

Study information

• Verified date: May 2009
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 2002
• Est. primary completion date: February 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pre-Dialysis

Intervention

Drug:
• darbepoetin alfa
10 mcg NESP administered SC every other week 15 mcg NESP administered SC every other week 20 mcg NESP administered SC every other week 30 mcg NESP administered SC every other week 40 mcg NESP administered SC every other week 50 mcg NESP administered SC every other week 60 mcg NESP administered SC every other week 80 mcg NESP administered SC every other week 100 mcg NESP administered SC every other week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

Suranyi MG, Lindberg JS, Navarro J, Elias C, Brenner RM, Walker R. Treatment of anemia with darbepoetin alfa administered de novo once every other week in chronic kidney disease. Am J Nephrol. 2003 Mar-Apr;23(2):106-11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the effectiveness of fixed dose(s) of NESP, administered once every other week, in the treatment of anemia in subjects with CRI		entire study - 24 weeks	No
Secondary	To assess the safety and tolerability of chronic NESP therapy		entire study - 24 weeks	Yes

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling