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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00563446
• Other study ID #: KWC/EX/05-041
• Secondary ID: HARECCTR0500029
• Status: Completed
• Phase: N/A
• First received: November 21, 2007
• Last updated: June 14, 2011
• Start date: July 2005
• Est. completion date: May 2006

Study information

• Verified date: June 2011
• Source: Hospital Authority, Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2006
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anemia
• Kidney Failure, Chronic
• Peritoneal Dialysis, Continuous Ambulatory
• Renal Insufficiency

Intervention

Drug:
• Darbepoetin alfa

Locations

Country	Name	City	State
China	Princess Margaret Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Authority, Hong Kong	Kirin Pharmaceutical (Asia) CO., LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin level		Over 6 months

External Links

•   HAREC Clinical Trial Registry