NCT00550680

Brief Summary

This single-arm study will assess the efficacy and safety of intravenous (IV) Mircera when administered for the maintenance of hemoglobin (Hb) levels in participants with chronic renal anemia. Individuals currently receiving maintenance treatment with epoetin alfa or darbepoetin alfa will receive monthly injections of Mircera, with the starting dose (120, 200, or 360 micrograms \[mcg\] IV injection) derived from the dose of epoetin alfa or darbepoetin alfa they were receiving in the week preceding study start.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

24 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

October 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
6.6 years until next milestone

Results Posted

Study results publicly available

March 30, 2016

Completed
Last Updated

March 30, 2016

Status Verified

February 1, 2016

Enrollment Period

1.7 years

First QC Date

October 29, 2007

Results QC Date

February 29, 2016

Last Update Submit

February 29, 2016

Conditions

Chronic Renal Anemia

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)

    Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the target range of 10.5 to 12.5 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.

    Weeks -4, -3, -2, -1,and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24

Secondary Outcomes (5)

  • Mean Change in Time-Adjusted Hb From Baseline to EEP

    At Weeks -4, -3, -2, -1, and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24

  • Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP

    Pre-dose (0 hours) during Weeks 18, 20, 22, and 24

  • Mean Time Spent in the Target Range for Hb During the EEP

    Pre-dose (0 hours) during Weeks 18, 20, 22, and 24

  • Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the Dose Titration Period (DTP) and EEP

    Weeks 0, 4, 8, 12, 16, 20, and 24

  • Number of Participants Prematurely Withdrawn From the Study to Receive Blood Transfusion

    Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24

Study Arms (1)

Mircera in Renal Anemia

EXPERIMENTAL

Participants with chronic renal anemia who have been previously treated with erythropoiesis-stimulating agent (ESA) therapy will receive IV Mircera every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment. Subsequent doses will be adjusted to maintain Hb concentrations within target of 10.5 and 12.5 grams per deciliter (g/dL).

Drug: Methoxy polyethylene glycol-epoetin beta

Interventions

Methoxy polyethylene glycol-epoetin betaDRUG

Participants will receive a starting dose of 120, 200, or 360 mcg via IV injection. Thereafter, the once-monthly dose will be titrated to achieve target Hb concentrations.

Also known as: Mircera/CERA
Mircera in Renal Anemia

Eligibility Criteria

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

You may qualify if:

  • Adults greater than or equal to (≥) 18 years of age
  • Chronic renal anemia
  • Stable epoetin alfa or darbepoetin alfa therapy for past 2 months
  • Hemodialysis therapy for ≥3 months

You may not qualify if:

  • Transfusion of red blood cells during previous 2 months
  • Poorly controlled hypertension requiring hospitalization or interruption of ESA treatment in previous 6 months
  • Acute or chronic bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Unknown Facility

Aigáleo, 12244, Greece

Location

Unknown Facility

Athens, 11362, Greece

Location

Unknown Facility

Athens, 11526, Greece

Location

Unknown Facility

Athens, 11527, Greece

Location

Unknown Facility

Athens, 11528, Greece

Location

Unknown Facility

Athens, 12462, Greece

Location

Unknown Facility

Athens, 18454, Greece

Location

Unknown Facility

Athens, 18536, Greece

Location

Unknown Facility

Corinthos, 20100, Greece

Location

Unknown Facility

Daphni-athens, 17237, Greece

Location

Unknown Facility

Ioannina, 455 00, Greece

Location

Unknown Facility

Kalamata, 24100, Greece

Location

Unknown Facility

Kyparissía, 24500, Greece

Location

Unknown Facility

Lamia, 35100, Greece

Location

Unknown Facility

Larissa, 41 110, Greece

Location

Unknown Facility

Larissa, 41221, Greece

Location

Unknown Facility

Livadeia, 32100, Greece

Location

Unknown Facility

Mytilene, 81100, Greece

Location

Unknown Facility

Pátrai, 26225, Greece

Location

Unknown Facility

Rhodes, 85100, Greece

Location

Unknown Facility

Thessaloniki, 546 42, Greece

Location

Unknown Facility

Thessaloniki, 54629, Greece

Location

Unknown Facility

Thessaloniki, 57001, Greece

Location

Unknown Facility

Thessaloniki, 57010, Greece

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

Interventions

continuous erythropoietin receptor activator

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2007

First Posted

October 30, 2007

Study Start

January 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

March 30, 2016

Results First Posted

March 30, 2016

Record last verified: 2016-02

Locations

GR(24)