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

NCT02439697 | Completed DMC

• 1 other identifier: Version 1.2 18thApril, 2015
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anemia; End Stage Renal Failure on Dialysis

Outcome Measures

Primary Outcomes (1)

• Haemoglobin

  6 months

Secondary Outcomes (5)

• Variability in haemoglobin level

  6 months

• average weekly dose of erythropoietin

  6 months

• safety profile of NESP

  6 months

• Subjective assessment of fatigue

  6 months

• Subjective assessment of pain

  6 months

Study Arms (3)

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®)

Other: Darbepoetin alfa

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.

Other: Darbepoetin alfa

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

Other: Darbepoetin alfa

Interventions

Darbepoetin alfa OTHER

Conversion from Aranesp® to NESP®

Also known as: NESP

Darbepoetin alfa (NESP®) 120mcg; Darbepoetin alfa (NESP®) same dose; Extended dosing Darbepoetin alfa (NESP®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Presence of
• thalassaemia
• haematological diseases
• severe hyperparathyroidism (PTH \>90 pmol/L)
• iron, vitamin B12 or folate deficiency
• uncontrolled malignancy
• active blood loss or hemolysis

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Division of Nephrology, Department of Medicine, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (4)

• 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.

  PMID: 12427142 BACKGROUND

• 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.

  PMID: 22140136 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.

  PMID: 18257808 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.

  PMID: 22073831 BACKGROUND

MeSH Terms

Conditions

Anemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Specialist

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 12, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: June 4, 2018

Record last verified: 2018-05

Locations

HK (1)