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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01417377
First Posted: August 16, 2011
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention
Anemia Drug: Mircera

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Study to Document the Efficacy in Routine Clinical Practice of Mircera in Pakistan (NORM)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Time to Achieve Hb Level to 11-12 g/dL [ Time Frame: Up to 6 months ]
  • Number of Dose Adjustments Required to Maintain Hb Levels [ Time Frame: 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 ]

Enrollment: 22
Actual Study Start Date: May 31, 2010
Study Completion Date: March 31, 2012
Primary Completion Date: March 31, 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronic kidney disease
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417377


Locations
Pakistan
Sheikh Zayed Hospital; Department of Nephrology
Lahore, Pakistan, 20021
Fatima Memorial Hospital; Nephrology
Lahore, Pakistan, 54590
Doctor's Hospital and Medical Centre
Lahore, Pakistan
Khair-un-Nisa Hospital
Lahore, Pakistan
Surgimed Hospital
Lahore, Pakistan
Northwest General Hospital; Department of Nephrology
Peshawar, Pakistan
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01417377     History of Changes
Other Study ID Numbers: ML25368
First Submitted: August 5, 2011
First Posted: August 16, 2011
Results First Submitted: September 24, 2015
Results First Posted: December 9, 2015
Last Update Posted: July 13, 2017
Last Verified: May 2017