A Study of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anemia.

NCT00576303 | Completed Phase 3 Results

• 1 other identifier: ML20977
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 18

Brief Summary

This single arm study will assess the efficacy, safety and tolerability of monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360 micrograms/month, depending on the dose of epoetin alfa or beta 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.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Maintaining Average Hemoglobin Concentration Within +\- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP

  All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The percentage of participants maintaining their mean Hemoglobin (Hb) concentration within +/- 1 gram/deciliter (g/dL) of their reference Hb and between 10.5 -12.5 g/dL is presented during the EEP. The EEP is defined as Week 16 to Week 24

  EEP (Week 16 to Week 24)

Secondary Outcomes (5)

• Mean Change in Hb Concentration From Baseline to the EEP

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

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

  EEP (Week 16 to Week 24)

• Mean Number of Days Spent Within Hb Range of 10.5-12.5 g/dL During the EEP

  EEP (Week 16 to Week 24)

• Number of Participants Requiring Any Dose Adjustment During the DTP, EEP, and LTSP

  DTP (Week 1 to Week 16), EEP (Week 16 to Week 24) and LTSP (Week 24 to Week 44)

• Number of Participants With Red Blood Cell Transfusion

  Up to 3 years

Study Arms (1)

RO0503821 (C.E.R.A.), 1x/4weeks

EXPERIMENTAL

Eligible participants started RO0503821 (Continuous Erythropoietin Receptor Activator \[C.E.R.A\]) intravenously, at a dose of 120, 200 or 360 microgram (µg) every four weeks. The dose of C.E.R.A was based on the epoetin alfa or beta dose of\<8000, 8000-16000, or \>16000 international units (IU)/week, administered during the stability verification period (SVP) of 4 weeks. The SVP period was followed by dose titration period (DTP) of 16 weeks, efficacy evaluation period (EEP) of 8 weeks and long term safety period (LTSP) of 28 weeks

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera] DRUG

120, 200 or 360 micrograms iv monthly (starting dose)

RO0503821 (C.E.R.A.), 1x/4weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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;
• continuous maintenance epoetin alfa or beta therapy with the same dosing interval during the previous 2 months.

You may not qualify if:

• transfusion of red blood cells during previous 2 months;
• poorly controlled hypertension requiring interruption of epoetin alfa or beta treatment in past 6 months;
• significant acute or chronic bleeding such as overt gastrointestinal bleeding;
• hemolysis;
• folic acid and vitamin B12 deficiency.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (18)

Unknown Facility

Kemerovo, 650066, Russia

Location

Unknown Facility

Krasnodar, 350086, Russia

Location

Unknown Facility

Moscow, 117049, Russia

Location

Unknown Facility

Moscow, 123182, Russia

Location

Unknown Facility

Moscow, 125101, Russia

Location

Unknown Facility

Moscow, 127006, Russia

Location

Unknown Facility

Moscow, 129110, Russia

Location

Unknown Facility

Moscow, 129317, Russia

Location

Unknown Facility

Novosibirsk, 630087, Russia

Location

Unknown Facility

Omsk, 644111, Russia

Location

Unknown Facility

Saint Petersburg, 191015, Russia

Location

Unknown Facility

Saint Petersburg, 195067, Russia

Location

Unknown Facility

Saint Petersburg, 196247, Russia

Location

Unknown Facility

Saint Petersburg, 197089, Russia

Location

Unknown Facility

Saint Petersburg, 197110, Russia

Location

Unknown Facility

Saint Petersburg, 198510, Russia

Location

Unknown Facility

Volzhsky, 404130, Russia

Location

Unknown Facility

Yekaterinburg, 620102, Russia

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: 26965694 DERIVED

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Name/Official Title:Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

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: December 18, 2007
• First Posted: December 19, 2007
• Study Start: April 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 26, 2016
• Results First Posted: May 26, 2016

Record last verified: 2016-04

Locations

RU (18)