Study of the Efficacy of Darbepoetin Alfa in the Treatment of Renal Anemia

Hospital Authority, Hong Kong

Status: Completed

Conditions: Anemia; Peritoneal Dialysis, Continuous Ambulatory; Kidney Failure, Chronic

Treatments: Drug: Darbepoetin alfa

Study type: Interventional

Funder types: Other

Identifiers

NCT00563446

HARECCTR0500029

KWC/EX/05-041

Details and patient eligibility

About

Anaemia is a common consequence of chronic renal failure. Darbepoetin alfa is a unique erythropoietic protein that stimulates erythropoiesis by the same mechanism as endogenous erythropietin and conventional recombinant human erythropoietin (rHuEPO). Darbepoetin alfa has been shown to have a serum half-life 3-fold longer than that of rHuEPO, which allows dosing at extended intervals and less frequent injection.

The objective is to evaluate the efficacy and safety of darbepoetin alfa therapy given at an extended once monthly dosing interval in the treatment of renal anaemia in continuous ambulatory peritoneal dialysis.

Enrollment: 16 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients on continuous ambulatory peritoneal dialysis
• Patients receiving subcutaneous recombinant human erythropoietin (rHuEPO)
• Patients with haemoglobin level ?10 g/dL and remain stable for the past 3 months while receiving rHuEPO

Exclusion criteria

• Uncontrolled hypertension
• Severe congestive heart failure (NYHA class III or IV)
• Grand mal epilepsy
• Any kind of blood loss causing Fe depletion
• Presence of infection, either acute or chronic, or inflammatory conditions within 3 months preceding the study
• Malignancy
• Aluminum toxicity
• Severe hyperparathyroidism with marrow fibrosis or osteitis fibrosa _ PTH > 20 times of normal
• Vitamin B12 or folate deficiency _ MCV > 100fL
• Haemolysis
• Marrow dysfunction e.g. aplastic anaemia, myelodysplastic syndrome, multiple myeloma, etc
• Thalassaemia major, intermediate or minor, or red cell enzyme defects
• Blood transfusion within 3 months preceding the study
• Pregnancy or lactating mothers

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)