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

Conversion From Once Weekly Recombinant Human Erythropoietin to Once Monthly Darbepoetin Alfa for the Treatment of Renal Anemia in Continuous Ambulatory Peritoneal Dialysis Patients

Sponsors

Lead Sponsor: Hospital Authority, Hong Kong

Collaborator: Kirin Pharmaceutical (Asia) CO., LTD

Source Hospital Authority, Hong Kong
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.

Overall Status Completed
Start Date July 2005
Completion Date May 2006
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Hemoglobin level Over 6 months
Enrollment 16
Condition
Intervention

Intervention Type: Drug

Intervention Name: Darbepoetin alfa

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

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Overall Official
Last Name Role Affiliation
Samuel KS Fung, Dr Principal Investigator Division of Nephrology, Medicine & Geriatrics, Princess Margaret Hospital
Location
Facility: Princess Margaret Hospital
Location Countries

China

Verification Date

June 2011

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Non-Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov