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

NCT ID: NCT00563446

Last Updated: 2011-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2006-05-31

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Darbepoetin alfa

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kirin Pharmaceutical (Asia) CO., LTD

UNKNOWN

Sponsor Role: collaborator

Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Samuel KS Fung, Dr

Role: PRINCIPAL_INVESTIGATOR

Division of Nephrology, Medicine & Geriatrics, Princess Margaret Hospital

Locations

Princess Margaret Hospital

Hong Kong, , China

Countries

China

Other Identifiers

HARECCTR0500029

Identifier Type: -

Identifier Source: secondary_id

KWC/EX/05-041

Identifier Type: -

Identifier Source: org_study_id