A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia

NCT00882713 | Completed Phase 3 Results

• 1 other identifier: ML21797
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 12

Brief Summary

This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting dose of 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. Treatment duration is 56 weeks, and the target sample size is 200 individuals.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period

  The percentage of participants who maintained their mean Hb concentration within +/- 1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the Efficacy Evaluation Period (EEP) is reported. The EEP was from Week 17 to Week 24. The reference Hb was calculated from the mean of Hb concentrations based upon the Hb assessments at Weeks -4, -3, -2, -1, and 0.

  EEP (Week 17 to Week 24)

Secondary Outcomes (18)

• Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period

  SVP (Weeks -3, -2, -1) and EEP (Week 17 to Week 24)

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

  EEP (Week 17 to Week 24)

• Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP

  EEP (Week 17 to Week 24)

• Number of Participants With Any Adverse Events or Serious Adverse Events

  Up to Week 52

• Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP

  DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24)

Study Arms (1)

C.E.R.A.

EXPERIMENTAL

Eligible participants will be administered continuous erythropoietin receptor activator (C.E.R.A.\[Mircera\]) intravenously (IV) every 4 weeks for 44 weeks. The starting dose of 120, 200, or 360 micrograms (mcg) will be based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses will be adjusted to maintain the individual participant's hemoglobin (Hb) within a range of +/- 1.0 grams per deciliter (g/dL) of the reference hemoglobin (Hb) concentration and between 10.50 and 12.50 g/dL.

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera] DRUG

Subcutaneous injection every 4 weeks (starting dose of 120, 200 or 360 micrograms, based on previous ESA therapy)

Also known as: C.E.R.A.

C.E.R.A.

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;
• regular long-term hemodialysis or peritoneal dialysis, with same mode of dialysis for \>=3 months;
• continuous iv maintenance epoetin alfa therapy with same dosing interval during previous 2 months.

You may not qualify if:

• transfusion of red blood cells during previous 2 months;
• poorly controlled hypertension;
• significant acute or chronic bleeding;
• active malignant disease (except non-melanoma skin cancer).

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (12)

Unknown Facility

Agadir, 70000, Morocco

Location

Unknown Facility

Casablanca, 20000, Morocco

Location

Unknown Facility

Casablanca, 20100, Morocco

Location

Unknown Facility

Casablanca, 21000, Morocco

Location

Unknown Facility

FÉS, 30000, Morocco

Location

Unknown Facility

Khouribga, 23000, Morocco

Location

Unknown Facility

Marrakesh, 40000, Morocco

Location

Unknown Facility

Méknés, 50300, Morocco

Location

Unknown Facility

Rabat, 10150, Morocco

Location

Unknown Facility

Rabat, 62001, Morocco

Location

Unknown Facility

Salé, 15045, Morocco

Location

Unknown Facility

Tangier, 90000, Morocco

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: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 616878333

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: February 17, 2009
• First Posted: April 16, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 7, 2016
• Results First Posted: October 7, 2016

Record last verified: 2016-08

Locations

MO (12)