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NCT Number: NCT00090753

A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia

This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. Eligible patients were those who were receiving stable maintenance therapy with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in Phase II or III clinical studies. They continued to receive methoxy polyethylene glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of administration (sc or iv) as in the qualifying studies.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clayton, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent
  • Adult patients (≥ 18 years old) with chronic renal anemia
  • Maintenance erythropoietic therapy with methoxy polyethylene glycol-epoetin beta or a protocol-specified reference medication (epoetin alfa formulated with human albumin, epoetin beta or darbepoetin alfa) in one of the following studies: BA16528[NCT00048048], BA16285[NCT00048035], BA16286[NCT00364832], BA16736[NCT00077597], BA16738[NCT00081471], BA16739[NCT00077610], BA16740[NCT00077623], BA17283[NCT00077766] and BA17284[NCT00081484]
  • Hemoglobin (Hb) concentration between 10.5 and 13.0 g/dL
  • Adequate iron status defined as serum ferritin ≥ 100 ng/mL or Transferrin Saturation (TSAT)≥ 20% or percentage of hypochromic red blood cells (RBCs) < 10%

Exclusion criteria

  • Poorly controlled hypertension
  • History of epileptic seizure
  • Pure red cell aplasia
  • Chronic congestive heart failure [New York Heart Association (NYHA) IV]
  • High likelihood of early withdrawal or interruption of the study
  • Active malignant disease (except non-melanoma skin cancer)
  • Life expectancy less than 12 months
  • Pregnancy or breast-feeding

Treatment and study plan

methoxy polyethylene glycol-epoetin beta

Drug

Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in 2-mL glass vials containing 1 mL solution or in single-use sterile pre-filled syringes (PFSs) containing 0.3 mL or 0.6 mL injectable solution. The injectable solution was available in vials with the following strengths: 50, 100, 200, 400, and 1000 μg/mL. The injectable solution was available in PFSs with the following strengths: 30, 40, 50, 60, 75, 100, 120, 150, 200, and 250 μg/0.3 mL; and 360 and 400 μg/0.6 mL.

Other names: RO0503821, Mircera

Epoetin alfa

Drug

Epoetin alfa was provided with commercial packaging in English with country-specific labels (10,000 IU, 20,000 IU).

Epoetin beta

Drug

Epoetin beta was provided with commercial packaging in English with country-specific labels (50,000 IU, 100,000 IU).

darbepoetin alfa

Drug

Darbepoetin alfa was provided with commercial packaging in English with country-specific labels (vials and PFSs in various strengths).

Primary outcomes

  1. Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation

    Time frame: Baseline to the end of the study (Up to 49 Months)

    Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely.

Secondary outcomes

  1. Percentage of Patients Who Had at Least 1 Adverse Event

    Time frame: From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)

    See the adverse events section of the results for more information.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-label, Multi-center Study to Document the Efficacy, Safety, and Tolerability of Long-term Administration of RO0503821 in Patients With Chronic Renal Anemia

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 6, 2004
Registry last updated
Feb 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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