NCT00773968

Brief Summary

This single arm study will assess the long term maintenance of hemoglobin (Hb) levels, safety and tolerability of once monthly subcutaneous methoxy polyethylene glycol-epoetin beta (CERA) in predialysis participants with chronic renal anemia. Participants currently receiving subcutaneous darbopoetin alfa maintenance treatment will receive subcutaneous methoxy polyethylene glycol-epoetin beta for a maximum of 32 weeks at a starting dose of 120, 200 or 360 micrograms every 4 weeks according to the dose of darbopoetin alfa administered in Week -1. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to 12 grams per deciliter (g/dL).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

34 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

Study Start

First participant enrolled

September 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

April 4, 2016

Completed
Last Updated

April 4, 2016

Status Verified

March 1, 2016

Enrollment Period

1.5 years

First QC Date

October 15, 2008

Results QC Date

March 4, 2016

Last Update Submit

March 4, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP)

    The reference Hb was defined as the average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0 (before the first dose administration).

    EEP: Weeks 17 to 28

Secondary Outcomes (5)

  • Change in Hb Concentrations Between EEP and Stability Verification Period (SVP)

    SVP: Week -4 to Week 0; EEP: Weeks 17 to 28

  • Percentage of Participants Maintaining Hb Concentrations Within the Range of 10.0 to 12.0 g/dL Throughout EEP

    EEP: Weeks 17 to 28

  • Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP

    EEP: Weeks 17 to 28

  • Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP

    DTP: Weeks 1 to 16; EEP: Weeks 17 to 28

  • Percentage of Participants Who Required Red Blood Cell Transfusions

    Weeks 1 to 28

Study Arms (1)

Methoxy Polyethylene Glycol-Epoetin Beta

EXPERIMENTAL

Participants will receive methoxy polyethylene glycol-epoetin beta once monthly by subcutaneous (SC) injection for 28 weeks.

Drug: Methoxy Polyethylene Glycol-Epoetin Beta

Interventions

Methoxy Polyethylene Glycol-Epoetin BetaDRUG

120, 200 or 360 micrograms every 4 weeks by subcutaneous injection.

Also known as: CERA
Methoxy Polyethylene Glycol-Epoetin Beta

Eligibility Criteria

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

You may qualify if:

  • Chronic renal anemia;
  • Continuous subcutaneous maintenance darbopoetin alfa treatment during previous month;
  • Hb concentration between 10 and 12 g/dL;
  • Adequate iron status.

You may not qualify if:

  • Transfusion of red blood cells during previous 2 months;
  • Significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
  • Poorly controlled hypertension requiring hospitalization or interruption of darbopoetin alfa treatment in the previous 6 months;
  • Active malignant disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

Unknown Facility

Barletta, Apulia, 70051, Italy

Location

Unknown Facility

Molfetta (Ba), Apulia, 70056, Italy

Location

Unknown Facility

Putignano, Apulia, 70017, Italy

Location

Unknown Facility

Caserta, Campania, 81100, Italy

Location

Unknown Facility

Eboli, Campania, 84025, Italy

Location

Unknown Facility

Napoli, Campania, 80131, Italy

Location

Unknown Facility

Nola, Campania, 80035, Italy

Location

Unknown Facility

Solofra, Campania, 83029, Italy

Location

Unknown Facility

Tivoli, Campania, 00019, Italy

Location

Unknown Facility

Bologna, Emilia-Romagna, 40138, Italy

Location

Unknown Facility

Pordenone, Friuli Venezia Giulia, 33170, Italy

Location

Unknown Facility

Albano Laziale, Lazio, 00041, Italy

Location

Unknown Facility

Civita Castellana, Lazio, 01033, Italy

Location

Unknown Facility

Viterbo, Lazio, 01100, Italy

Location

Unknown Facility

Savona, Liguria, 17100, Italy

Location

Unknown Facility

Cinisello Balsamo, Lombardy, 20092, Italy

Location

Unknown Facility

Cremona, Lombardy, 26100, Italy

Location

Unknown Facility

Mantova, Lombardy, 46100, Italy

Location

Unknown Facility

Monza, Lombardy, 20052, Italy

Location

Unknown Facility

Pavia, Lombardy, 27100, Italy

Location

Unknown Facility

S Fermo Della Battaglia, Lombardy, 22020, Italy

Location

Unknown Facility

Varese, Lombardy, 21100, Italy

Location

Unknown Facility

Campobasso, Molise, 86100, Italy

Location

Unknown Facility

Alessandria, Piedmont, 15100, Italy

Location

Unknown Facility

Chivasso, Piedmont, 10034, Italy

Location

Unknown Facility

Catania, Sicily, 95124, Italy

Location

Unknown Facility

Erice, Sicily, 91016, Italy

Location

Unknown Facility

Messina, Sicily, 98122, Italy

Location

Unknown Facility

Palermo, Sicily, 90127, Italy

Location

Unknown Facility

Ancona, The Marches, 60131, Italy

Location

Unknown Facility

Pesaro, The Marches, 61100, Italy

Location

Unknown Facility

Lido di Camaiore, Tuscany, 55043, Italy

Location

Unknown Facility

Pistoia, Tuscany, 51100, Italy

Location

Unknown Facility

Siena, Tuscany, 53100, Italy

Location

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title
Medical Communications
Organization
Hoffman-La Roche
genentech@druginfo.com
800-821-8590

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

October 15, 2008

First Posted

October 16, 2008

Study Start

September 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

April 4, 2016

Results First Posted

April 4, 2016

Record last verified: 2016-03

Locations

IT(34)