STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients

May 17, 2016 updated by: Hoffmann-La Roche

A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis participants with chronic renal anemia. Participants will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the dose of epoetin administered in the week preceding first study drug administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

188

Phase

  • Phase 3

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

  • Czech Republic
      • Brno, Czech Republic, 656 91
      • Cesky Krumlov, Czech Republic, 38127
      • Decin, Czech Republic, 405 99
      • Havirov, Czech Republic, 736 24
      • Hradec Kralove, Czech Republic, 500 05
      • Jihlava, Czech Republic, 586 33
      • Karlovy Vary, Czech Republic, 360 73
      • Kolin Iii, Czech Republic, 280 20
      • Liberec, Czech Republic, 460 63
      • Novy Jicin, Czech Republic, 741 11
      • Olomouc, Czech Republic, 775 20
      • Ostrava, Czech Republic, 708 52
      • Pisek, Czech Republic, 397 23
      • Praha, Czech Republic, 150 30
      • Praha, Czech Republic, 128 08
      • Praha, Czech Republic, 14000
      • Praha 6, Czech Republic, 169 00
      • Strakonice, Czech Republic, 38629
      • Sumperk, Czech Republic, 787 01
      • Tabor, Czech Republic, 390 03
      • Teplice, Czech Republic, 415 01
      • Trebic, Czech Republic, 674 01
      • Usti Nad Labem, Czech Republic, 401 13
      • Znojmo, Czech Republic, 76275

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic renal anemia;
  • Continuous stable intravenous maintenance epoetin therapy during previous month;
  • Regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.

Exclusion Criteria:

  • Transfusion of red blood cells during previous 2 months;
  • Poorly controlled hypertension, that is, sitting blood pressure exceeding 170/100 millimeter of mercury (mmHg) despite medication;
  • Significant acute or chronic bleeding.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms iv monthly (starting dose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range
Time Frame: Week 17 up to Week 24
Percentage of participants maintaining their mean hemoglobin concentration in g/dL within plus or minus (+/-) 1 g/dL of their reference hemoglobin value, and between the target range of 10.0 and 12.0 g/dL during the efficacy evaluation period (EEP). The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the Stability Verification Period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 up to Week 24) was estimated as a time adjusted average.
Week 17 up to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin Concentration Between Reference (SVP) and EEP
Time Frame: Week -4 up to Week -1 and Week 17 up to Week 24
The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week -1) and the value during EEP (Week 17 up to Week 24) was assessed.
Week -4 up to Week -1 and Week 17 up to Week 24
Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP
Time Frame: Week 17 up to Week 24
Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.
Week 17 up to Week 24
Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP
Time Frame: Week 17 up to Week 24
Mean time spent by participants with hemoglobin concentration in the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.
Week 17 up to Week 24
Percentage of Participants Requiring Any Dose Adjustment
Time Frame: Week 1 to Week 16 and Week 17 to Week 24
Percentage of participants requiring adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.
Week 1 to Week 16 and Week 17 to Week 24
Number of Participants With Red Blood Cell Transfusion During the Study
Time Frame: Week -4 up to Week 28
Number of participant who underwent red blood cell transfusion during the study was reported.
Week -4 up to Week 28
Number of Participants With Anti-epoetin Antibody
Time Frame: Week -4 and at early withdrawal or Week 28
Week -4 and at early withdrawal or Week 28

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 25, 2008

Study Record Updates

Last Update Posted (Estimate)

June 23, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML21040

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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