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

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ClinicalTrials.gov Identifier: NCT00563446
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : June 16, 2011
Sponsor:
Collaborator:
Kirin Pharmaceutical (Asia) CO., LTD
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Anemia Kidney Failure, Chronic Peritoneal Dialysis, Continuous Ambulatory Drug: Darbepoetin alfa Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : July 2005
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine





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


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00563446     History of Changes
Other Study ID Numbers: KWC/EX/05-041
HARECCTR0500029
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: June 16, 2011
Last Verified: June 2011

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

Additional relevant MeSH terms:
Anemia
Renal Insufficiency
Kidney Failure, Chronic
Hematologic Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Darbepoetin alfa
Hematinics