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

This study has been completed.
Sponsor:
Collaborator:
Kirin Pharmaceutical (Asia) CO., LTD
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00563446
First received: November 21, 2007
Last updated: June 14, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Anemia
Kidney Failure, Chronic
Peritoneal Dialysis, Continuous Ambulatory
Drug: Darbepoetin alfa

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

Resource links provided by NLM:


Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:
  • Hemoglobin level [ Time Frame: Over 6 months ]

Estimated Enrollment: 16
Study Start Date: July 2005
Study Completion Date: May 2006
  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563446

Locations
China
Princess Margaret Hospital
Hong Kong, China
Sponsors and Collaborators
Hospital Authority, Hong Kong
Kirin Pharmaceutical (Asia) CO., LTD
Investigators
Principal Investigator: Samuel KS Fung, Dr Division of Nephrology, Medicine & Geriatrics, Princess Margaret Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00563446     History of Changes
Other Study ID Numbers: KWC/EX/05-041, HARECCTR0500029
Study First Received: November 21, 2007
Last Updated: June 14, 2011
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
Anemia
End-stage renal failure
Continuous ambulatory peritoneal dialysis

Additional relevant MeSH terms:
Anemia
Kidney Failure, Chronic
Renal Insufficiency
Hematologic Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014