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This is a prospective single-arm open-labeled cohort study on dialysis patients of the conversion from Aranesp® to NESP® for the treatment of anemia. The primary outcome of the study is the haemoglobin level after conversion to NESP® after 6 months. Secondary outcomes include the variability in haemoglobin level, average weekly dose of erythropoietin, safety profile of NESP®, patients' subjective assessment of fatigue and injection pain after the conversion.
Currently in Hong Kong, Aranesp®, manufactured by Amgen® is the only available Darbepoetin alpha licensed. NESP®, a Darbepoetin alpha agent manufactured by Kirin®, will be replacing Aranesp®.It is important to evaluate the therapeutic equivalence of the two agents, and its efficacy, tolerability and safety profile in the treatment of anemia in dialysis patients. Moreover, a new maximum preparation of NESP 120® microgram will be available to replace the Aranesp® 100 microgram prefilled syringe at the same cost. This larger Darbepoetin alpha preparation may allow extension of dosing intervals. This may subsequently allow cost saving and better convenience to medical staff and patients.
The objectives of this project are:
To investigate the effectiveness of NESP® in the achieving a stable anemia control in chronic dialysis patients with the same dose conversion from Aranesp®
To investigate the effectiveness of increasing the dosing interval of NESP® (but maintaining the same total dose) in sustaining a stable anemia control in chronic dialysis patients
To explore the possibility of cost saving in administering a larger dose NESP® but at an extended interval
Patients will be divided into 3 groups.
Group A. Same dose conversion group
• Patients on stable low dose Aranesp® (on 20mcg preparations or on 40mcg every 2 weeks or less) will be converted to the same dose of NESP®
Group B. Attempt extension of dosing interval with higher dose of NESP® preparations
• Patients on stable dose of Aranesp® will be converted to higher dose preparation of NESP® (40 or 120 mcg preparations) with extended dosing intervals.
Group C. Attempt dosage saving with 120 mcg preparation
• Patients on Aranesp® 100mcg will be switched to the NESP® 120mcg preparation with slight increase in dosing interval
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Darbepoetin alfa (NESP®) same dose | Experimental | Patients on stable low dose Aranesp® (darbepoetin alfa manufactured by Amgen®) (on 20mcg preparations or on 40mcg every 2 weeks or less) will be converted to the same dose of NESP® (darbepoetin alfa manufactured by Kirin®) |
|
| Extended dosing Darbepoetin alfa (NESP®) | Experimental | Patients on stable dose of Aranesp® (darbepoetin alfa manufactured by Amgen®) will be converted to higher dose preparation of NESP® (darbepoetin alfa manufactured by Kirin®) 40 or 120 mcg preparations) with extended dosing intervals. The total dose of Darbepoetin alpha remains the same. |
|
| Darbepoetin alfa (NESP®) 120mcg | Experimental | Patients on Aranesp® 100 mcg preparation (darbepoetin alfa manufactured by Amgen®) will be switched to the NESP® (darbepoetin alfa manufactured by Kirin®)120mcg preparation with slight increase in dosing interval according to the conversion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darbepoetin alfa | Other | Conversion from Aranesp® to NESP® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Haemoglobin | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Variability in haemoglobin level | 6 months | |
| average weekly dose of erythropoietin | 6 months | |
| safety profile of NESP |
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Inclusion Criteria:
Exclusion Criteria:
Presence of
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| Name | Affiliation | Role |
|---|---|---|
| Maggie Ming Yee Mok, MBBS FHKAM | Queen Mary Hosptial, the University of Hong KOng | Principal Investigator |
| Tak Mao Chan, MBBS FRCP | Queen Mary Hospital, the University of Hong Kong | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Nephrology, Department of Medicine, Queen Mary Hospital | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12427142 | Background | Vanrenterghem Y, Barany P, Mann JF, Kerr PG, Wilson J, Baker NF, Gray SJ; European/Australian NESP 970200 Study Group. Randomized trial of darbepoetin alfa for treatment of renal anemia at a reduced dose frequency compared with rHuEPO in dialysis patients. Kidney Int. 2002 Dec;62(6):2167-75. doi: 10.1046/j.1523-1755.2002.00657.x. | |
| 22140136 |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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|
Blood pressure, Questionnaire on the occurrence of side-effects such as seizure, pure red cell aplasia, etc. |
| 6 months |
| Subjective assessment of fatigue | Visual Analogue Fatigue Scale | 6 months |
| Subjective assessment of pain | Numeric Pain Numeric Pain Rating Scale | 6 months |
| Galle JC, Claes K, Kiss I, Winearls CG, Herlitz H, Guerin A, Di Giulio S, Suranyi MG, Bridges I, Addison J, Farouk M. An observational cohort study of extended dosing (once every 2 weeks or once monthly) regimens with darbepoetin alfa in patients with chronic kidney disease not on dialysis: the EXTEND study. Nephrol Dial Transplant. 2012 Jun;27(6):2303-11. doi: 10.1093/ndt/gfr677. Epub 2011 Dec 2. |
| 18257808 | Background | Hiramatsu M, Kubota M, Iwasaki M, Akizawa T, Koshikawa S; KRN321 A09 Study Group. Darbepoetin alfa (KRN321) administered intravenously once monthly maintains hemoglobin levels in peritoneal dialysis patients. Ther Apher Dial. 2008 Feb;12(1):19-27. doi: 10.1111/j.1744-9987.2007.00525.x. |
| 22073831 | Background | Suzuki H, Inoue T, Watanabe Y, Kikuta T, Sato T, Tsuda M, Uchida K. Testing a single monthly dose of darbepoetin alpha to maintain hemoglobin levels in continuous ambulatory peritoneal dialysis patients. Adv Perit Dial. 2011;27:60-4. |
| D002241 |
| Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |