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

NCT00563446 | Completed

• 2 other identifiers: KWC/EX/05-041HARECCTR0500029
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

Anemia; End-stage renal failure; Continuous ambulatory peritoneal dialysis

Outcome Measures

Primary Outcomes (1)

• Hemoglobin level

  Over 6 months

Interventions

Darbepoetin alfa DRUG

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead
• Kirin Pharmaceutical (Asia) CO., LTD: collaborator

Study Sites (1)

Princess Margaret Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Anemia; Kidney Failure, Chronic

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Samuel KS Fung, Dr

  Division of Nephrology, Medicine & Geriatrics, Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 26, 2007
• Study Start: July 1, 2005
• Study Completion: May 1, 2006
• Last Updated: June 16, 2011

Record last verified: 2011-06

Locations

CN (1)