NCT00442793

Brief Summary

This 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta, in patients with chronic renal anemia who are on dialysis. Eligible patients will be randomized to receive either Mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta (3 times weekly, according to approved labelling). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
265

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2007

Typical duration for phase_3

Geographic Reach
2 countries

14 active sites

Status
completed

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

March 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

3 years

First QC Date

March 1, 2007

Last Update Submit

November 1, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (2)

  • Hb response rate

    Weeks 0-24

  • Change in Hb concentration between baseline and evaluation period

    Months 4-6

Secondary Outcomes (5)

  • Hb over time

    Throughout study

  • Time to Hb response

    Throughout study

  • RBC transfusions

    Weeks 0-24

  • AEs, laboratory parameters, vital signs

    Throughout study

  • Serum concentration of Mircera

    Throughout study

Study Arms (2)

1

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

2

ACTIVE COMPARATOR
Drug: Epoetin beta

Interventions

Epoetin betaDRUG

As prescribed, 3 times weekly

2
methoxy polyethylene glycol-epoetin beta [Mircera]DRUG

0.4 micrograms/kg iv every 2 weeks

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 requiring dialysis;
  • maintenance hemodialysis or peritoneal dialysis for \>=2 weeks before and during screening;
  • adequate iron status.

You may not qualify if:

  • previous epoetin treatment within 8 weeks prior to screening;
  • failing renal graft in place;
  • bleeding episode necessitating transfusion within 8 weeks prior to screening;
  • poorly controlled hypertension;
  • previous treatment with Mircera.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Beijing, 100050, China

Location

Unknown Facility

Beijing, 10029, China

Location

Unknown Facility

Beijing, 100853, China

Location

Unknown Facility

Chengdu, 610072, China

Location

Unknown Facility

Guangzhou, 510515, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Hangzhou, 310003, China

Location

Unknown Facility

Nanjing, 210009, China

Location

Unknown Facility

Shanghai, 200001, China

Location

Unknown Facility

Shanghai, 200003, China

Location

Unknown Facility

Shanghai, 200025, China

Location

Unknown Facility

Shanghai, 200032, China

Location

Unknown Facility

Shanghai, 200040, China

Location

Unknown Facility

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Anemia

Interventions

epoetin betacontinuous 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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2007

First Posted

March 2, 2007

Study Start

May 1, 2007

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

CN(13)HK(1)