NCT00605293

Brief Summary

This 2 arm study will compare the efficacy and safety of monthly administration of intravenous (IV) Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Participants currently receiving maintenance treatment with epoetin alfa will be randomized either to receive monthly injections of 120, 200 or 360 micrograms Mircera, with the starting dose derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. The anticipated duration of study is 32 weeks, and the target sample size is 146 participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

19 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

January 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2008

Completed
1.9 years 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
6.4 years until next milestone

Results Posted

Study results publicly available

May 13, 2016

Completed
Last Updated

May 13, 2016

Status Verified

October 1, 2013

Enrollment Period

2 years

First QC Date

January 18, 2008

Results QC Date

April 8, 2016

Last Update Submit

April 8, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP

    Participants who maintained average Hb concentration within +/-1 g/dL of their reference Hb and between 10 to 12 g/dL during EEP are reported. The reference Hb value was defined on the basis of all assessments at Weeks -4, -3, -2, -1 and 0.

    EEP (Week 16 to 23)

Secondary Outcomes (5)

  • Change in Hb Concentrations Between Baseline SVP and the EEP

    SVP (Week -4 to -1), EEP (Week 16 to 23)

  • Percentage of Participants Who Maintained Hb Concentration Between 10 and 12 g/dL Throughout the EEP

    EEP (Week 16 to 23)

  • Mean Time Spent in Hb Range 10-12 g/dL

    SVP (Week -4 to -1), DTP (Week 0 to 15), and EEP (Week 16 to 23)

  • Percentage of Participants Who Required Dose Adjustments During the DTP and EEP

    DTP (Week 0 to 15) and EEP (Week 16 to 23)

  • Percentage of Participants Who Received Red Blood Cell (RBC) Transfusions During DTP and EEP

    DTP (Week 0 to 15) up to EEP (Week 16 to 23)

Study Arms (2)

C.E.R.A

EXPERIMENTAL

Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.

Drug: methoxy polyethylene glycol-epoetin beta

Epoetin Alfa

ACTIVE COMPARATOR

Participants received IV injection of 6000 International Units (IU) of epoetin alfa every 3 weeks (q3wk) during the Stability Verification Period (SVP; Week -4 to -1), and 7443 IU of epoetin alfa q3wk during Dose Titration Period (DTP; Week 0 to 15), 7363 IU of epoetin alfa q3wk during Efficacy Evaluation Period (EEP; Week 16 to 23) up to 23 weeks.

Drug: Epoetin alfa

Interventions

methoxy polyethylene glycol-epoetin betaDRUG

120, 200 or 360 micrograms iv/month (starting dose)

Also known as: Mircera; C.E.R.A
C.E.R.A
Epoetin alfaDRUG

As prescribed

Epoetin Alfa

Eligibility Criteria

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

You may qualify if:

  • chronic renal anemia;
  • continuous iv maintenance epoetin alfa therapy, with the same dosing interval during the previous month to and during SVP;
  • regular hemodialysis for greater than or equal to (\>=) 3 months

You may not qualify if:

  • transfusion of red blood cells during previous 2 months
  • poorly controlled hypertension requiring interruption of epoetin alfa treatment in previous 6 months;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Unknown Facility

Badajoz, Badajoz, 06300, Spain

Location

Unknown Facility

Barcelona, Barcelona, 08035, Spain

Location

Unknown Facility

Cáceres, Caceres, 10310, Spain

Location

Unknown Facility

Cádizv, Cadiz, 11008, Spain

Location

Unknown Facility

Castellon, Castellon, 12004, Spain

Location

Unknown Facility

Ciudad Real, Ciudad Real, 13005, Spain

Location

Unknown Facility

Huelva, Huelva, 21005, Spain

Location

Unknown Facility

Madrid, Madrid, 28034, Spain

Location

Unknown Facility

Madrid, Madrid, 28041, Spain

Location

Unknown Facility

Madrid, Madrid, 28905, Spain

Location

Unknown Facility

Marbella, Malaga, 29603, Spain

Location

Unknown Facility

Tudela, Navarre, 46010, Spain

Location

Unknown Facility

Pontevedra, Pontevedra, 36071, Spain

Location

Unknown Facility

Salamanca, Salamanca, 37008, Spain

Location

Unknown Facility

Teruel, Teruel, 44003, Spain

Location

Unknown Facility

Valencia, Valencia, 46009, Spain

Location

Unknown Facility

Valencia, Valencia, 46010, Spain

Location

Unknown Facility

Zamora, Zamora, 49022, Spain

Location

Unknown Facility

Zaragoza, Zaragoza, 50009, Spain

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 activatorEpoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-LaRoche
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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2008

First Posted

January 31, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

May 13, 2016

Results First Posted

May 13, 2016

Record last verified: 2013-10

Locations

ES(19)