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

June 15, 2017 updated by: Hoffmann-La Roche

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Lahore, Pakistan, 20021
        • Sheikh Zayed Hospital; Department of Nephrology
      • Lahore, Pakistan, 54590
        • Fatima Memorial Hospital; Nephrology
      • Lahore, Pakistan
        • Doctor's Hospital and Medical Centre
      • Lahore, Pakistan
        • Khair-un-Nisa Hospital
      • Lahore, Pakistan
        • Surgimed Hospital
      • Peshawar, Pakistan
        • Northwest General Hospital; Department of Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with chronic kidney disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort
Mircera
Drug: Mircera
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Month 4 up to Month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Achieve Hb Level to 11-12 g/dL
Time Frame: Up to 6 months
Up to 6 months
Number of Dose Adjustments Required to Maintain Hb Levels
Time Frame: Up to 6 months
Up to 6 months
Number of Doses of Mircera Taken as Per the Schedule in Summary of Product Characteristics (SmPC)
Time Frame: Up to 6 months
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2010

Primary Completion (Actual)

March 31, 2012

Study Completion (Actual)

March 31, 2012

Study Registration Dates

First Submitted

August 5, 2011

First Submitted That Met QC Criteria

August 15, 2011

First Posted (Estimate)

August 16, 2011

Study Record Updates

Last Update Posted (Actual)

July 13, 2017

Last Update Submitted That Met QC Criteria

June 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • ML25368

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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