NCT00680563

Brief Summary

This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_3

Geographic Reach
9 countries

18 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2008

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

November 5, 2013

Status Verified

November 1, 2013

Enrollment Period

9 months

First QC Date

May 16, 2008

Last Update Submit

November 4, 2013

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP).

    Week 32

Secondary Outcomes (5)

  • Time to achievement of response

    Throughout study

  • Percentage of patients whose Hb concentration remains within range 10.0-12.0g/dL

    Throughout study

  • Percentage of patients whose average Hb concentration is within range 10.0 - 12.0g/dL

    Throughout study

  • Mean time spent in Hb range of 10.0 - 12.0g/dL

    Throughout study

  • Percentage of patients requiring dose adjustments; incidence of RBC transfusions; time to initiation of renal replacement therapy.

    Throughout study

Study Arms (1)

1

EXPERIMENTAL
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera]DRUG

sc every month (starting dose 1.2 micrograms/kg)

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients, \>=18 years of age;
  • chronic renal anemia;
  • no ESA therapy during previous 3 months;
  • adequate iron status;
  • rapid chronic kidney disease progression.

You may not qualify if:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension requiring hospitalization in previous 6 months;
  • significant acute or chronic bleeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Unknown Facility

Buenos Aires, CP2700, Argentina

Location

Unknown Facility

La Plata, 1900, Argentina

Location

Unknown Facility

San Miguel de Tucumán, 4000, Argentina

Location

Unknown Facility

Blumenau, 89010-500, Brazil

Location

Unknown Facility

Botucatu, 18618-000, Brazil

Location

Unknown Facility

Curitiba, 80250-070, Brazil

Location

Unknown Facility

Rio de Janeiro, 20551-030, Brazil

Location

Unknown Facility

São Paulo, 01246-903, Brazil

Location

Unknown Facility

São Paulo, 04039-901, Brazil

Location

Unknown Facility

Santiago, 056, Chile

Location

Unknown Facility

Santiago, 8900000, Chile

Location

Unknown Facility

Barranquilla, 575, Colombia

Location

Unknown Facility

Cali, 572, Colombia

Location

Unknown Facility

Envigado, 571, Colombia

Location

Unknown Facility

Medellín, 0, Colombia

Location

Unknown Facility

San José, Costa Rica

Location

Unknown Facility

Quito, 2569, Ecuador

Location

Unknown Facility

Guatemala City, Guatemala

Location

Unknown Facility

Panama City, Panama

Location

Unknown Facility

Lima, L13, Peru

Location

Unknown Facility

San Isidro, Lima 27, Peru

Location

Unknown Facility

Caracas, 1020, Venezuela

Location

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2008

First Posted

May 20, 2008

Study Start

April 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

November 5, 2013

Record last verified: 2013-11

Locations

CO(1)PA(1)CL(2)GU(1)PE(2)AR(3)VE(1)EC(1)BR(6)