Comparison Among Erythropoietin Stimulating Agents

NCT02049346 | Completed Phase 4 DMC

• 1 other identifier: 11021/11
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 1

Brief Summary

\* Background: Despite extensive use, to the best of our knowledge, no trial has simultaneously compared the three currently used erythropoietin stimulating agents (ESAs) in a prospective manner, in treatment of anemia of end stage renal disease (ESRD) patients. \* Patients and Methods: All haemodialysis patients in Qatar who were treated with short acting Epoetin alfa or beta were screened. Eligible patients were randomized, either to continue on the previous regimen of Epoetin, or to receive Darbepoetin alfa or continuous erythropoietin receptor activator (C.E.R.A) for a total period of 40 weeks. All groups were assessed at the end of the study for safety and efficacy parameters.

Conditions

Anemia of End Stage Renal Disease

Keywords

Anemia; Hemodialysis; Erythropoetin Stimulating Agents; Comparison

Outcome Measures

Primary Outcomes (1)

• Comparison of efficacy among erythropoetin stimulating agents.

  To evaluate efficacy of continuous erythropoietin receptor activator (C.E.R.A.) and Darbepoetin Alfa, to maintain Hemoglobin level - within the target recommended range - among ESRD patients, in direct comparison to currently available ESA (Epoetin alfa and beta). by measuring percentage of cases with mean Hemoglobin concentration between 11-12 gm/dl and measuring mean monthly hemoglobin concentrations.

  Every week up to 36 weeks

Secondary Outcomes (1)

• comparison between safety profile of different types of erythropoetin simulating agents.

  Up 36 weeks

Study Arms (3)

Epoetin alpha or beta (Epoetin group)

ACTIVE COMPARATOR

Patients in that arm were continued on the previous same dose and route of administration of Epoetin alpha/ beta (Epoetin group).

Drug: Epoetin alpha or beta (Epoetin group)

Darbepoetin alpha

ACTIVE COMPARATOR

subjects in that group received Darbepoetin alfa once every week or every 2 weeks as per protocol.

Drug: Darbepoetin alfa

Methoxy polyethylene glycol-epoetin beta

EXPERIMENTAL

Patients in that arm received Intravenous Methoxy polyethylene glycol-epoetin beta monthly.

Drug: Methoxy polyethylene glycol-epoetin beta

Interventions

Epoetin alpha or beta (Epoetin group) DRUG

Erythropoetin doses in that were adjusted according to the approved prescribing information, without additional restrictions. Doses of erythropoetin were decreased by 25% for Hb values \>12 and ≤13 g/dL and increased by 25% for Hb \<11 and ≥10 g/dL. erythropoetin doses were increased by 50% for Hb \<10 g/dL. Treatment was interrupted temporarily if Hb exceeds 13 g/dL. The doses for all patients were adjusted so that haemoglobin concentrations were maintained within a target range of 11-12 g/dL during the study.

Also known as: Recormon, Eprex

Epoetin alpha or beta (Epoetin group)

Darbepoetin alfa DRUG

Subjects in that group received Darbepoetin alfa once every week or every 2 weeks as per protocol. Doses of Darbepoetin alfa were decreased by 25% for Hb values \>12 and ≤13 g/dL and increased by 25% for Hb \<11 and ≥10 g/dL. Darbepoetin alfa doses and increased by 50% for Hb \<10 g/dL. Treatment was interrupted temporarily if Hb exceeds 13 g/dL. The doses were adjusted so that haemoglobin concentrations were remain within a target range of 11-12 g/dL during the study. If a dose of Epoetin alpha/ beta does not equate exactly to a unit dose of Darbepoetin alfa at switching, then the nearest available unit dose of Darbepoetin alfa was used.

Also known as: Aranesp

Darbepoetin alpha

Methoxy polyethylene glycol-epoetin beta DRUG

Patients in that arm received Intravenous MIRCERA monthly. The initial dose was 120 mcg, 200 mcg or 360 mcg, for patients had previously received a weekly dose of Epoetin alpha/ beta of less than 8000 IU, between 8000 to16 000 IU or more than16000IU respectively. MIRCERA doses were adjusted according to the approved prescribing information, without additional restrictions. Doses of MIRCERA were decreased by 25% for Hb values \>12 and ≤13 g/dL and increased by 25% for Hb \<11 and ≥10 g/dL. MIRCERA doses were increased by 50% for Hb \<10 g/dL. Treatment was interrupted temporarily if Hb exceeds 13 g/dL. The doses of MIRCERA were adjusted so that haemoglobin concentrations were maintained within a target range of 11-12 g/dL during the study.

Also known as: MIRCERA

Methoxy polyethylene glycol-epoetin beta

Eligibility Criteria

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

You may qualify if:

• Aged ≥18 years
• have stable chronic renal anemia (with hemoglobin range of 10-12 g/dL) and on regular haemodialysis 3 x week with urea reduction ratio greater or equal to 65% or KT/V ( K - dialyzer clearance of urea, t - dialysis time, V - volume of distribution of urea, approximately equal to patient's total body water) greater or equal to 1.2.
• Patients must have received haemodialysis three times weekly for ≥12 weeks before screening and during the 4-week screening/baseline period.
• Eligible patients must have stable hemoglobin concentrations (stable is defined as ≤25% change in weekly dose of ESA over 8 weeks).
• Recruited patients must have undergone continuous maintenance intravenous conventional Epoetin alpha or beta therapy for ≥8 weeks before screening and during the screening/baseline.
• Patients should have adequate iron status, defined as serum ferritin ≥100 μg/L and transferrin saturation ≥20%.

You may not qualify if:

• New York Heart Association (NYHA) class III or IV congestive heart failure
• Uncontrolled hypertension (defined as pre-dialysis diastolic blood pressure
• mmHg or systolic BP≥ 160 mmHg during the screening period)
• Evidence of uncontrolled hyperparathyroidism (defined as parathyroid hormone level \>1000 pg/ml with no response to conventional treatment of hyperparathyroidism according to Kidney Disease Outcomes Quality Initiative (KDOQI) guide line during the 12 months prior to baseline)
• Treatment for grand mal epilepsy
• Haematological, inflammatory or infectious conditions that might interfere with the erythropoietin response
• Received red blood cell transfusions within 12 weeks before screening or during the screening/baseline period.
• reactive protein \>30 mg/L
• The likelihood of early withdrawal; or life expectancy of \<12 months
• Poor compliance with dialysis treatment, evidenced by \>2 missed treatment monthly over the previous 3 months10. Refuse to be involved in the study.

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Fahd Bin Jassem Dialysis Centre

Doha, 30550, Qatar

Location

Related Publications (1)

• 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

MeSH Terms

Conditions

Anemia

Interventions

epoetin beta; Epoetin Alfa; Darbepoetin alfa; continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

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

Study Officials

• Fadwa S. AL-Ali, MD

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 30, 2014
• Study Start: March 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 13, 2017

Record last verified: 2014-01

Locations

QA (1)