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

Completed

• Conditions: Renal Tubular Acidosis, Distal, With Hemolytic Anemia
• Interventions: Other: No intervention

• Registration Number: NCT02490514
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2015-07-02
• Study First Submitted QC: 2015-07-02
• Study First Posted: 2015-07-03
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mircera	No intervention	Patients with stage III-IV CKD received open-label Mircera for 12 months at a dose to be determined by the investigator.

Primary Outcome Measures

Name	Time	Method
Percent Of Participants Who Reached And Maintained Target Hemoglobin Values During Treatment	12 months

Secondary Outcome Measures

Name	Time	Method
Percent Of Participants Treated With Iron Supplements	12 months
Mircera Dose At Start And End Of Treatment	12 months
Hb Levels At Start And End Of Treatment	12 months
Time To Achieve Response To Mircera	12 months
Percent of Participants Who Required Transfusion At Start And End Of Treatment	12 months