A Cohort Study of Conversion From Aranesp® to NESP® for the Treatment of Anemia in Dialysis Patients

Anemia Clinical Trial

Official title:

A Cohort Study of Conversion From Aranesp® to NESP® for the Treatment of Anemia in Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02439697
• Other study ID #: Version 1.2 18thApril, 2015
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: November 2017

Study information

• Verified date: May 2018
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

1. To investigate the effectiveness of NESP® in the achieving a stable anemia control in chronic dialysis patients with the same dose conversion from Aranesp®

2. 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

3. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult Chinese patients (age greater than or equal to 18)

• on long-term dialysis for at least 3 months

• on Aranesp® treatment for at least 3 months

• stable hemoglobin level within the range of 9 to12 g/dL, on the same stable dose of Aranesp® within the past 2 months.

• Minimum weekly kT/V of 1.7 for peritoneal dialysis patients and 1.2 per haemodialysis session for haemodialysis patients

• Able to give informed consent

Exclusion Criteria:

Presence of

• thalassaemia

• haematological diseases

• severe hyperparathyroidism (PTH >90 pmol/L)

• iron, vitamin B12 or folate deficiency

• uncontrolled malignancy

• active blood loss or hemolysis

Related Conditions & MeSH terms

• Anemia
• End Stage Renal Failure on Dialysis
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Other:
• Darbepoetin alfa
Conversion from Aranesp® to NESP®

Locations

Country	Name	City	State
Hong Kong	Division of Nephrology, Department of Medicine, Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Vanrenterghem Y, Bárány 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemoglobin		6 months
Secondary	Variability in haemoglobin level		6 months
Secondary	average weekly dose of erythropoietin		6 months
Secondary	safety profile of NESP	Blood pressure, Questionnaire on the occurrence of side-effects such as seizure, pure red cell aplasia, etc.	6 months
Secondary	Subjective assessment of fatigue	Visual Analogue Fatigue Scale	6 months
Secondary	Subjective assessment of pain	Numeric Pain Numeric Pain Rating Scale	6 months