Cost Comparison Study of Darbepoetin Versus Epoetin Therapy to Treat Anemia in Hemodialysis Patients

NCT02817555 | Completed Phase 4 Results

• 1 other identifier: HIC10.104
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if there is a cost difference between darbepoetin alfa and epoetin alfa when used intravenously to treat anemia in hemodialysis patients.

Conditions

Anemia; Chronic Kidney Disease

Keywords

Anemia; Hemodialysis; Erythropoiesis Stimulating Agent; Cost

Outcome Measures

Primary Outcomes (1)

• Cost of Erythropoiesis Stimulating Agent

  total cost over 12 months in Canadian dollars

  12 months

Secondary Outcomes (5)

• Hemoglobin

  12 months

• Ferritin

  12 months

• Transferrin Saturation (TSAT)

  12 months

• Iron Dose

  12 months

• Iron Cost

  12 months

Study Arms (2)

Epoetin alfa

ACTIVE COMPARATOR

Patients who are enrolled and randomized to the Epoetin arm will remain on their current dose and frequency. After the first hemoglobin (Hb) measurement the study algorithm will be used to guide anemia management. The subjects in this arm will remain on epoetin for the required run-in phase followed by the 12 month active phase.

Drug: Epoetin Alfa

Darbepoetin alfa

ACTIVE COMPARATOR

Patients who are enrolled and randomized to the Darbepoetin arm will have their epoetin discontinued at the end of the week preceding entry into the study and will switch to darbepoetin on the date that they would normally be receiving their next dose of epoetin. Switching patients to darbepoetin will be done using the conversion ratio of 200 units of epoetin to 1 μg of darbepoetin as used per week, rounded up or down to the nearest available pre-filled syringe dose available from the manufacturer. After the first Hb measurement the study algorithm will be used to guide anemia management. The subjects in this arm will remain on darbepoetin for the required run-in phase followed by the 12 month active phase.

Drug: Darbepoetin alfa

Interventions

Epoetin Alfa DRUG

The investigator will adjust epoetin doses as per the study algorithm during the run-in (every two weeks) and active phases (every four weeks). This will continue until the 12 month active phase is complete or the patient is withdrawn from the study. All epoetin will be administered intravenously through a hemodialysis machine port using a manufacturer-provided pre-filled syringe. It is not anticipated that a subject will require a dose of epoetin \> 30 000 units weekly. If this occurs the dose will not be escalated any higher. Such a patient would likely meet the criteria for study withdrawal. Intravenous iron will be given as per the study algorithm and only one formulation of iron is used, sodium ferric gluconate.

Also known as: Eprex

Epoetin alfa

Darbepoetin alfa DRUG

The investigator will adjust darbepoetin doses as per the study algorithm during the run-in (every two weeks) and active phases(every four weeks). This will continue until the 12 month active phase is complete or the patient is withdrawn from the study. All darbepoetin will be administered intravenously through a hemodialysis machine port using a manufacturer-provided pre-filled syringe. It is not anticipated that a subject will require a dose of darbepoetin \>150µg weekly. If this occurs the dose will not be escalated any higher. Such a patient would likely meet the criteria for study withdrawal. Intravenous iron will be given as per the study algorithm and only one formulation of iron is used, sodium ferric gluconate.

Also known as: Aranesp

Darbepoetin alfa

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥19 years
• receiving in-center hemodialysis two or more times weekly
• anemia requiring erythropoiesis stimulating (ESA) agent therapy OR a hemoglobin(Hb)\<100g/L in the absence of other causes of anemia
• if female, must be using an approved method of contraception or judged unable to become pregnant
• able to give informed consent

You may not qualify if:

• acute kidney injury likely to resolve
• plans to change to peritoneal dialysis or home hemodialysis, or planned transplant from a living donor
• expected lifespan of less than six months due to a medical condition other than chronic kidney disease
• current hematologic condition that may cause anemia
• use of medications known to cause anemia
• use of any investigational drug or androgen within 90 days of screening
• significant bleeding within 30 days of screening
• red blood cell transfusion(s) within 30 days of screening
• documented or suspected pure red cell aplasia (PRCA)
• current iron deficiency
• documented allergy or intolerance to intravenous sodium ferric gluconate
• known or probable ESA resistance
• uncontrolled hypertension
• an intention to relocate to a different dialysis center in the near future

Sponsors & Collaborators

• Andrea L Woodland: lead

Related Publications (2)

• Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

  PMID: 36791280 DERIVED

• Woodland AL, Murphy SW, Curtis BM, Barrett BJ. Costs Associated With Intravenous Darbepoetin Versus Epoetin Therapy in Hemodialysis Patients: A Randomized Controlled Trial. Can J Kidney Health Dis. 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. eCollection 2017.

  PMID: 28717516 DERIVED

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Interventions

Epoetin Alfa; Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

Did not recruit planned number, incomplete follow up in 8 subjects, cannot be generalized to centres without pre-defined dosing algorithms, non-dialysis CKD, or sc administration of ESAs. Trial looked at drug acquisition cost only.

Results Point of Contact

• Title: Andrea Woodland
• Organization: Eastern Health

andrea.woodland@easternhealth.ca

7097778146

Study Officials

• Andrea L Woodland, BScPharm,MSc

  Eastern Health, Canada

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Pharmacist

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: June 29, 2016
• Study Start: September 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 10, 2019
• Results First Posted: September 10, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share