STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients

NCT00642850 | Completed Phase 3 Results

• 1 other identifier: ML21040
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 24

Brief Summary

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis participants with chronic renal anemia. Participants will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the dose of epoetin administered in the week preceding first study drug administration. 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 Per Deciliter (g/dL) of Reference and Within the Target Range

  Percentage of participants maintaining their mean hemoglobin concentration in g/dL within plus or minus (+/-) 1 g/dL of their reference hemoglobin value, and between the target range of 10.0 and 12.0 g/dL during the efficacy evaluation period (EEP). The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the Stability Verification Period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 up to Week 24) was estimated as a time adjusted average.

  Week 17 up to Week 24

Secondary Outcomes (6)

• Change in Hemoglobin Concentration Between Reference (SVP) and EEP

  Week -4 up to Week -1 and Week 17 up to Week 24

• Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP

  Week 17 up to Week 24

• Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP

  Week 17 up to Week 24

• Percentage of Participants Requiring Any Dose Adjustment

  Week 1 to Week 16 and Week 17 to Week 24

• Number of Participants With Red Blood Cell Transfusion During the Study

  Week -4 up to Week 28

Study Arms (1)

1

EXPERIMENTAL

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera] DRUG

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

1

Eligibility Criteria

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

You may qualify if:

• Chronic renal anemia;
• Continuous stable intravenous maintenance epoetin therapy during previous month;
• Regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.

You may not qualify if:

• Transfusion of red blood cells during previous 2 months;
• Poorly controlled hypertension, that is, sitting blood pressure exceeding 170/100 millimeter of mercury (mmHg) despite medication;
• Significant acute or chronic bleeding.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (24)

Unknown Facility

Brno, 656 91, Czechia

Location

Unknown Facility

Český Krumlov, 38127, Czechia

Location

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Děčín, 405 99, Czechia

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Havířov, 736 24, Czechia

Location

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Hradec Králové, 500 05, Czechia

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Jihlava, 586 33, Czechia

Location

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Karlovy Vary, 360 73, Czechia

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Unknown Facility

Kolin III, 280 20, Czechia

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Liberec, 460 63, Czechia

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Nový Jičín, 741 11, Czechia

Location

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Olomouc, 775 20, Czechia

Location

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Ostrava, 708 52, Czechia

Location

Unknown Facility

Písek, 397 23, Czechia

Location

Unknown Facility

Prague, 128 08, Czechia

Location

Unknown Facility

Prague, 14000, Czechia

Location

Unknown Facility

Prague, 150 30, Czechia

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Unknown Facility

Prague, 169 00, Czechia

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Unknown Facility

Strakonice, 38629, Czechia

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Šumperk, 787 01, Czechia

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Tábor, 390 03, Czechia

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Unknown Facility

Teplice, 415 01, Czechia

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Unknown Facility

Třebíč, 674 01, Czechia

Location

Unknown Facility

Ústí nad Labem, 401 13, Czechia

Location

Unknown Facility

Znojmo, 76275, Czechia

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: 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: March 19, 2008
• First Posted: March 25, 2008
• Study Start: November 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: June 23, 2016
• Results First Posted: June 23, 2016

Record last verified: 2016-05

Locations

CZ (24)