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AnemiaNCT02439697

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

A study testing Darbepoetin alfa in people with Anemia and End Stage Renal Failure on Dialysis, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia, End Stage Renal Failure on Dialysis
What is being tested?
Darbepoetin alfa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteHong Kong
Study dates
Nov 2015to Nov 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Division of Nephrology, Department of Medicine, Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

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.

Read the 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
Being tested
Darbepoetin alfa
Medical subject headings
Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Darbepoetin alfaOther

    Also called NESP

    Conversion from Aranesp® to NESP®

Study groups in NCT02439697
Study groupRoleWhat they receive
Darbepoetin alfa (NESP®) same doseExperimentalPatients 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®)
Receives: Other: Darbepoetin alfa
Extended dosing Darbepoetin alfa (NESP®)ExperimentalPatients 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.
Receives: Other: Darbepoetin alfa
Darbepoetin alfa (NESP®) 120mcgExperimentalPatients 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
Receives: Other: Darbepoetin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Haemoglobin

    Measured: 6 months

Secondary outcomes (5)

  1. Variability in haemoglobin level

    Measured: 6 months

  2. average weekly dose of erythropoietin

    Measured: 6 months

  3. safety profile of NESP

    Blood pressure, Questionnaire on the occurrence of side-effects such as seizure, pure red cell aplasia, etc.

    Measured: 6 months

  4. Subjective assessment of fatigue

    Visual Analogue Fatigue Scale

    Measured: 6 months

  5. Subjective assessment of pain

    Numeric Pain Numeric Pain Rating Scale

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionNov 2017
  4. Study completionNov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02439697
Sponsor's protocol ID
Version 1.2 18thApril, 2015
Status last verified
May 2018
First submitted
4 May 2015
Last updated
4 Jun 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 12427142

  • 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.

    PubMed 22140136

  • 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.

    PubMed 18257808

  • 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.

    PubMed 22073831

Questions about this trial

What is this clinical trial studying?

A study testing Darbepoetin alfa in people with Anemia and End Stage Renal Failure on Dialysis, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Haemoglobin (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02439697, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.

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