A Study Comparing Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Every 4 Weeks Mircera Versus Epoetin Beta in Dialysis Patients With Chronic Renal Anemia.

NCT00773331 | Completed Phase 3

• 1 other identifier: ML21904
• Study Type: interventional
• Target: 281
• Locations: 1 country
• Sites: 13

Brief Summary

This two arm study will compare the maintenance of hemoglobin levels, safety and tolerability of once every 4 weeks subcutaneous administration of Mircera versus epoetin beta in dialysis patients with chronic renal anemia. Patients will be randomized to receive either subcutaneous Mircera (starting dose 120, 200 or 360 micrograms) every 4 weeks or subcutaneous epoetin beta in accordance with the prescribed dosing information. In both groups, the starting dose will be the same as the previous dose of epoetin beta administered in the week preceding first study drug administration. Patients will be treated for 28 weeks with follow up 4 weeks after the last treatment visit. 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)

• Change in hemoglobin concentration between baseline and the EEP

  Week 20-28

Secondary Outcomes (3)

• Proportion of patients maintaining average Hb concentration within the target range during the EEP; proportion of patients maintaining Hb concentration between 10-12g/dL throughout the EEP.

  Weeks 1-28

• Mean time spent in the Hb range 10 - 12g/dL; incidence of red blood cell transfusions during the DTP and EEP.

  Weeks 1-28

• Incidence of adverse events and serious adverse events; vital signs, laboratory parameters, ECG.

  Throughout study

Study Arms (2)

1

EXPERIMENTAL

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

2

ACTIVE COMPARATOR

Drug: epoetin beta

Interventions

epoetin beta DRUG

As prescribed

2

methoxy polyethylene glycol-epoetin beta [Mircera] DRUG

120, 200 or 360 micrograms every 4 weeks

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female patients, \>=18 years of age;
• chronic renal anemia;
• Hb concentration 10.0 - 12.0 g/dL during the screening period;
• continuous subcutaneous maintenance therapy with epoetin at the same dose AND same dosing interval for at least 12 weeks before and throughout screening.

You may not qualify if:

• blood transfusion within the previous 8 weeks;
• poorly controlled hypertension;
• significant or acute or chronic bleeding;
• active malignant disease;
• congestive heart failure (NYHA Class IV).

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (13)

Unknown Facility

Beijing, 100034, China

Location

Unknown Facility

Beijing, 100044, China

Location

Unknown Facility

Beijing, 100050, China

Location

Unknown Facility

Beijing, 100083, China

Location

Unknown Facility

Beijing, 100853, China

Location

Unknown Facility

Chengdu, 610072, China

Location

Unknown Facility

Guangzhou, 510515, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Hangzhou, 310003, China

Location

Unknown Facility

Nanjing, 210009, China

Location

Unknown Facility

Nanjing, 210036, China

Location

Unknown Facility

Shanghai, 200001, China

Location

Unknown Facility

Shanghai, 200025, China

Location

MeSH Terms

Conditions

Anemia

Interventions

epoetin beta; continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

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: October 15, 2008
• First Posted: October 16, 2008
• Study Start: July 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

CN (13)