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

August 17, 2015 updated by: Hoffmann-La Roche

Mircera In Patients With CKD Stages III-IV Not On Dialysis: Observational, Non-interventional Cohort Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients 18 to 75 years old with stage III-IV chronic kidney disease not on dialysis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Of Participants Who Reached And Maintained Target Hemoglobin Values During Treatment
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

July 2, 2015

First Submitted That Met QC Criteria

July 2, 2015

First Posted (Estimate)

July 3, 2015

Study Record Updates

Last Update Posted (Estimate)

August 18, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25065

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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