A Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia

October 30, 2015 updated by: Hoffmann-La Roche

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

This open label, single arm study will assess the efficacy for long-term maintenance of haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin beta [Mircera] in dialysis patients with chronic renal anaemia. Patients on regular long-term haemodialysis or peritoneal dialysis will receive monthly subcutaneous or intravenous Mircera for 6 months. Target sample size is <200 patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 4

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

  • Taiwan
      • Kaohsiung, Taiwan, 807
      • New Taiepei City, Taiwan
      • Taichung, Taiwan, 404

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:

  • adult patients, >/=18 years of age
  • chronic renal anaemia
  • haemoglobin 10.0-12.0g/dl at screening
  • adequate iron status
  • continuous stable ESA (erythropoietic stimulating agent) therapy for >/= 2 months
  • regular haemodialysis or regular peritoneal dialysis for >/= 3 months

Exclusion Criteria:

  • uncontrolled hypertension
  • haemoglobinopathy
  • anaemia due to haemolysis
  • pure red cell aplasia (PRCA)

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: Single Arm
Procedure: Dialysis
regular haemodialysis or peritoneal dialysis
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
once monthly, subcutaneously or intravenously, for 32 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range
Time Frame: Weeks 1 to 32
Percentage of participants who maintained the Hb concentration within target range (between 10.0 and 12.0 grams per deciliter [g/dL]) throughout the treatment period were reported.
Weeks 1 to 32

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Monthly Hb Values
Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8
The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8
Change in Hb Concentration Between Reference and Treatment Period
Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8
The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8
Mean Time Participants Spent Having Hb Concentration Within Target Range
Time Frame: Weeks 1 to 32
Target Hb concentration was between 10.0 and 12.0 g/dL.
Weeks 1 to 32
Percentage of Participants Requiring Dose Adjustments
Time Frame: Baseline to Month 1; Month 1 to 2; Month 2 to 3; Month 3 to 4; Month 4 to 5; Month 5 to 6; Month 6 to 7; Month 7 to 8
Dose adjustment included: Dose Increase; No Change; and Dose Decreased. Participants who did not have this data available are reported as Not Done. Results are reported for overall treatment arm.
Baseline to Month 1; Month 1 to 2; Month 2 to 3; Month 3 to 4; Month 4 to 5; Month 5 to 6; Month 6 to 7; Month 7 to 8

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

October 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

July 1, 2010

First Submitted That Met QC Criteria

July 1, 2010

First Posted (Estimate)

July 2, 2010

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

October 30, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML22299

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.

Clinical Trials on Anemia

Clinical Trials on Dialysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe