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

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ClinicalTrials.gov Identifier: NCT01417377
Recruitment Status : Completed
First Posted : August 16, 2011
Results First Posted : December 9, 2015
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment
Anemia Drug: Mircera

Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Study to Document the Efficacy in Routine Clinical Practice of Mircera in Pakistan (NORM)
Actual Study Start Date : May 31, 2010
Actual Primary Completion Date : March 31, 2012
Actual Study Completion Date : March 31, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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