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A Study Of Mircera In Patients With Kidney Disease Who Are Not On Dialysis

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ClinicalTrials.gov Identifier: NCT02490514
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : August 18, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This open-label, non-randomized, retrospective-prospective, non-interventional study will evaluate the efficacy and safety of Mircera in patients with stage III-IV chronic kidney disease (CKD) not on dialysis. Patients will receive open-label treatment with Mircera for 12 months at a dose to be determined by the investigator.

Condition or disease Intervention/treatment
Renal Tubular Acidosis, Distal, With Hemolytic Anemia Other: No intervention

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Study Type : Observational
Actual Enrollment : 153 participants
Observational Model: Cohort
Official Title: Mircera In Patients With CKD Stages III-IV Not On Dialysis: Observational, Non-interventional Cohort Study
Study Start Date : December 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012


Group/Cohort Intervention/treatment
Mircera
Patients with stage III-IV CKD received open-label Mircera for 12 months at a dose to be determined by the investigator.
Other: No intervention
No intervention was administered in this study.




Primary Outcome Measures :
  1. Percent Of Participants Who Reached And Maintained Target Hemoglobin Values During Treatment [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Hb Levels At Start And End Of Treatment [ Time Frame: 12 months ]
  2. Mircera Dose At Start And End Of Treatment [ Time Frame: 12 months ]
  3. Time To Achieve Response To Mircera [ Time Frame: 12 months ]
  4. Percent Of Participants Treated With Iron Supplements [ Time Frame: 12 months ]
  5. Percent of Participants Who Required Transfusion At Start And End Of Treatment [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients 18 to 75 years old with stage III-IV chronic kidney disease not on dialysis
Criteria

Inclusion Criteria:

  • Patients with stage II-IV CKD not on dialysis, including renal transplant patients, who are receiving erythropoiesis-stimulating agent (ESA) treatment or are ESA-naive
  • Patients who will not require dialysis within 12 months after the start of Mircera therapy
  • Patients whose life expectancy is greater than 12 months after Mircera initiation
  • Patients >/= 18 years and </= 75 years of age
  • Patients who are female and of childbearing potential must be using effective contraception methods
  • Patients with no contra-indications to ESA treatment (for example, hypersensitivity, non-controlled hypertension and others according to the local SmPC)
  • Patients who have given written informed consent where local regulations allow or require it

Exclusion Criteria:

  • Patients with stage I-II or stage V CKD
  • Poorly controlled hypertension
  • Active malignant disease

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): NCT02490514


Locations
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Serbia
Belgrade, Serbia, 11000
Cuprija, Serbia, 35230
Kragujevac, Serbia, 34000
NIS, Serbia, 18000
Pirot, Serbia, 18300
Pozarevac, Serbia, 12000
Sabac, Serbia, 15000
Sremska Mitrovica, Serbia, 22000
Uzice, Serbia, 31000
Zrenjanin, Serbia, 23000
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: NCT02490514     History of Changes
Other Study ID Numbers: ML25065
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Acidosis, Renal Tubular
Anemia, Hemolytic
Acidosis
Acid-Base Imbalance
Metabolic Diseases
Anemia
Hematologic Diseases
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn