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An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Chronic Kidney Disease Not On Dialysis

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.
 
ClinicalTrials.gov Identifier: NCT01318512
Recruitment Status : Completed
First Posted : March 18, 2011
Results First Posted : December 3, 2015
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This observational, prospective, multicenter study will describe the mean dose of Mircera (methoxy polyethylene glycol-epoetin beta) and the hemoglobin levels in patients with chronic kidney disease. Patients are not on dialysis and are naive to, or have received erythropoiesis stimulating agent treatment. Data will be collected for 10 months.

Condition or disease
Kidney Disease, Chronic

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Study Type : Observational
Actual Enrollment : 340 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Dosage of MIRCERA in the Treatment of Renal Anaemia in Patients With Chronic Renal Disease Who do Not Undergo Haemodialysis in Clinical Practice
Actual Study Start Date : July 31, 2010
Actual Primary Completion Date : December 31, 2013
Actual Study Completion Date : December 31, 2013

Resource links provided by the National Library of Medicine


Group/Cohort
Chronic Kidney Disease
Participants with CKD, not undergoing haemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of haemoglobin.



Primary Outcome Measures :
  1. Average Dose of MIRCERA at Entry Level [ Time Frame: Baseline ]
    The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported.

  2. Average Dose of MIRCERA During Titration Period Month 1 [ Time Frame: Month 1 ]
    The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported.

  3. Average Dose of MIRCERA During Titration Period Month 2 [ Time Frame: Month 2 ]
    The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.

  4. Average Dose of MIRCERA During Titration Period Month 3 [ Time Frame: Month 3 ]
    The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.

  5. Average Dose of MIRCERA During Titration Period Month 4 [ Time Frame: Month 4 ]
    The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.

  6. Average Dose of MIRCERA During Maintenance Period Month 1 [ Time Frame: Month 5 (Maintenance Period Month 1) ]
    The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

  7. Average Dose of MIRCERA During Maintenance Period Month 2 [ Time Frame: Month 6 (Maintenance Period Month 2) ]
    The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

  8. Average Dose of MIRCERA During Maintenance Period Month 3 [ Time Frame: Month 7 (Maintenance Period Month 3) ]
    The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

  9. Average Dose of MIRCERA During Maintenance Period Month 4 [ Time Frame: Month 8 (Maintenance Period Month 4) ]
    The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

  10. Average Dose of MIRCERA During Maintenance Period Month 5 [ Time Frame: Month 9 (Maintenance Period Month 5) ]
    The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

  11. Average Dose of MIRCERA During Maintenance Period Month 6 [ Time Frame: Month 10 (Maintenance Period Month 6) ]
    The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.


Secondary Outcome Measures :
  1. The Mean Hemoglobin (Hb) Level During Titration Period [ Time Frame: Baseline, Month 1, 2, 3, 4 ]
    The hemoglobin level was measured in grams per liter (g/L) at entry level and after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA.

  2. The Mean Hemoglobin (Hb) Level During Maintenance Period [ Time Frame: Month 5, 6, 7, 8, 9, 10 ]
    The hemoglobin level was measured in grams per liter (g/L) after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA



Information from the National Library of Medicine

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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 receiving Mircera treatment
Criteria

Inclusion Criteria:

  • Adults patients, >/=18 years of age
  • Presence of chronic kidney disease (Stage 3-4)

Exclusion Criteria:

  • Participation in another clinical study

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): NCT01318512


Locations
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Czechia
Nemocnice Novy Jicin; Dialyzacni Stredisko
Novy Jicin, Czechia, 741 11
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01318512    
Other Study ID Numbers: ML25317
First Posted: March 18, 2011    Key Record Dates
Results First Posted: December 3, 2015
Last Update Posted: July 5, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency