Clinical Trial Details

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Study ID ML25065
Investigator
Clinical Trials,   Hoffmann-La Roche
Title A Study Of Mircera In Patients With Kidney Disease Who Are Not On Dialysis
Conditions Renal Tubular Acidosis, Distal, With Hemolytic Anemia
Interventions Other: No intervention
Phase N/A
Purpose 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.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Both
Accepts Healthy Volunteers:  No
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
  • 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
  • Study Location N/A
    Contact N/A

    Information obtained from ClinicalTrials.gov, on 7/6/2015. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
    Please refer to this study by its ClinicalTrials.gov identifier: NCT02490514


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