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NCT Number: NCT01417377

An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Anemic Patients With Chronic Kidney Disease (NORM)

This observational, prospective, multi-centre, single-arm study will evaluate the efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease previously on treatment with short-acting epoetin alpha. Data will be collected for 6 months.

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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

Observational

Primary location

Doctor's Hospital and Medical Centre, Lahore, Pakistan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients, age 18 years or above
  • Chronic kidney disease (CKD) with anemia
  • Patients on dialysis receiving short-acting epoetin (EPO)
  • Serum ferritin level >/=100 ng/ml or transferrin saturation (TSAT) >/=20%

Exclusion criteria

  • Patients unwilling to give informed consent
  • Uncontrolled hypertension
  • Transfusion of red blood cells within 8 weeks of the start of Mircera treatment
  • Relevant acute or chronic bleeding history
  • Hemolysis
  • Hemoglobinopathies
  • Pure red cell aplasia

Treatment and study plan

Mircera

Drug

Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha will be observed for a period of 6 months.

Primary outcomes

  1. Percentage of Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study

    Time frame: Month 4 up to Month 6

Secondary outcomes

  1. Time to Achieve Hb Level to 11-12 g/dL

    Time frame: Up to 6 months

  2. Number of Dose Adjustments Required to Maintain Hb Levels

    Time frame: Up to 6 months

  3. Number of Doses of Mircera Taken as Per the Schedule in Summary of Product Characteristics (SmPC)

    Time frame: Up to 6 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Non-Interventional Study to Document the Efficacy in Routine Clinical Practice of Mircera in Pakistan (NORM)

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 16, 2011
Registry last updated
Jul 13, 2017

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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