Clinical trial NCT02439697: A Cohort Study of Conversion From Aranesp® to NESP® for the Treatment of Anemia in Dialysis Patients
Official title: A Cohort Study of Conversion From Aranesp® to NESP® for the Treatment of Anemia in Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
End Stage Renal Failure on Dialysis
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Haemoglobin
timeFrame: 6 months
Secondary outcomes:
measure: Variability in haemoglobin level
timeFrame: 6 months
measure: average weekly dose of erythropoietin
timeFrame: 6 months
measure: safety profile of NESP
timeFrame: 6 months
measure: Subjective assessment of fatigue
timeFrame: 6 months
measure: Subjective assessment of pain
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Division of Nephrology, Department of Medicine, Queen Mary Hospital
Study officials:
affiliation: Queen Mary Hosptial, the University of Hong KOng
name: Maggie Ming Yee Mok, MBBS FHKAM
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen Mary Hospital, the University of Hong Kong
name: Tak Mao Chan, MBBS FRCP
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
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.
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.