NCT00517413

Brief Summary

This single arm study will assess the efficacy and safety of Mircera when administered once monthly, subcutaneously or intravenously, for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will receive monthly injections of Mircera with a starting dose (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
163

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2007

Typical duration for phase_3

Geographic Reach
9 countries

28 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

August 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
2.6 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
6 years until next milestone

Results Posted

Study results publicly available

April 29, 2016

Completed
Last Updated

April 29, 2016

Status Verified

March 1, 2016

Enrollment Period

2.6 years

First QC Date

August 16, 2007

Results QC Date

February 24, 2016

Last Update Submit

March 29, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Maintaining Their Mean Hb Concentration Within ±1.0 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter

    The haemoglobin (Hb) levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The reference Hb value was defined on the basis of individual participant's all assessments at Weeks -4, -3, -2, -1 and 0. The Hb value on the first day of first dose (Week 0) was included in the calculation, as this assessment was performed before the first dose was given. The percentage of participants maintaining their mean Hb concentration within +/-1.0 gram/deciliter (g/dL) of their reference Hb and between 10.5 and 12.5 g/dL are reported for efficacy evaluation period (EEP). Efficacy evaluation period was from Week 16 to Week 24 after completion of 16-week dose titration period (DTP).

    EEP (Week 16 to 24)

Secondary Outcomes (17)

  • Mean Change in the Hb Concentration Between the Stability Verification Period and the EEP

    SVP (Week -4 to -1), EEP (Week 16 to 24)

  • Percentage of Participants Maintaining Hb Concentration Within The Target Range 10.5 and 12.5 g/dL Throughout the EEP

    EEP (Week 16 to 24)

  • Mean Time Spent by the Participants in the Hb Target Range 10.5-12.5 g/dL During EEP

    EEP (Week 16 to 24)

  • Mean C.E.R.A Dose To Maintain Hb Level Within the Range 10.5-12.5 g/dL Throughout the EEP

    EEP (Week 16 to 24)

  • Percentage of Participants Requiring Dose Adjustments of C.E.R.A During the DTP and EEP

    Baseline (Week 0) to Week 24

  • +12 more secondary outcomes

Study Arms (1)

C.E.R.A

EXPERIMENTAL

Participants with chronic renal anaemia who were on dialysis and previously treated with intravenous (IV) or subcutaneous (SC) epoetin alfa, epoetin beta or darbepoetin alfa received monthly treatment with Continuous Erythropoietin Receptor Activator (C.E.R.A.) (methoxy polyethylene glycol-epoetin beta \[Mircera\]). The initial dose of C.E.R.A. was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA); 120, 200, or 360 micrograms (mcg) C.E.R.A., IV or SC, every 4 weeks for 48 weeks.

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera]DRUG

120, 200 or 360 micrograms sc or iv monthly, starting dose

C.E.R.A

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;
  • hemodialysis or peritoneal dialysis, with same mode of dialysis for \>=3 months before and throughout screening period;
  • stable maintenance epoetin alfa therapy for past 2 months.

You may not qualify if:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension requiring interruption of epoetin alfa in past 6 months;
  • acute or chronic bleeding during previous 2 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Unknown Facility

Buenos Aires, 1155, Argentina

Location

Unknown Facility

Buenos Aires, 1437, Argentina

Location

Unknown Facility

Buenos Aires, 1663, Argentina

Location

Unknown Facility

Buenos Aires, 1824, Argentina

Location

Unknown Facility

Córdoba, 5000, Argentina

Location

Unknown Facility

Santa Fe, 3000, Argentina

Location

Unknown Facility

Aracajú, 49055-210, Brazil

Location

Unknown Facility

Curitiba, 80050-350, Brazil

Location

Unknown Facility

Fortaleza, 60430-370, Brazil

Location

Unknown Facility

São Paulo, 05624-000, Brazil

Location

Unknown Facility

Santiago, 056, Chile

Location

Unknown Facility

Bogotá, 0, Colombia

Location

Unknown Facility

Bogotá, Colombia

Location

Unknown Facility

Quito, 2569, Ecuador

Location

Unknown Facility

Cuernavaca, 62448, Mexico

Location

Unknown Facility

Mexico City, 03900, Mexico

Location

Unknown Facility

Mexico City, 11520, Mexico

Location

Unknown Facility

Mexico City, 14000, Mexico

Location

Unknown Facility

Mexico City, 14050, Mexico

Location

Unknown Facility

Monterrey, 64710, Mexico

Location

Unknown Facility

Callao, C 01, Peru

Location

Unknown Facility

Callao, C01, Peru

Location

Unknown Facility

Lima, L13, Peru

Location

Unknown Facility

Montevideo, 11600, Uruguay

Location

Unknown Facility

Montevideo, 11800, Uruguay

Location

Unknown Facility

Caracas, 1060, Venezuela

Location

Unknown Facility

Caracas, 1062, Venezuela

Location

Unknown Facility

Maracaibo, 4002, Venezuela

Location

Related Publications (1)

  • Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.

    PMID: 26965694DERIVED

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title
Roche Trial Information Hotline
Organization
F. Hoffmann-La Roche AG
global.trial_information@roche.com
+41 616878333

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

August 16, 2007

First Posted

August 17, 2007

Study Start

October 1, 2007

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

April 29, 2016

Results First Posted

April 29, 2016

Record last verified: 2016-03

Locations

VE(3)PE(3)UR(2)BR(4)CO(2)AR(6)EC(1)CL(1)ME(6)