A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia

NCT00661505 | Completed Phase 3 Results

• 1 other identifier: ML21096
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 20

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 hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. 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 Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period

  The reference hemoglobin (Hb) value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0). The time adjusted average Hb concentration of all the values recorded during the efficacy evaluation period (EEP) was calculated for each participant and their reference Hb concentration was subtracted from this value. The percentage of participants maintaining their average Hb concentration during the EEP within +/- 1 gram/deciliter (g/dL) of their reference Hb concentration and between the Hb range 10.0 -12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24. Data missing at the end of the EEP was handled using the last value carried forward method, including any data missing due to withdrawal of participants following red blood cells (RBC) transfusion.

  EEP (Week 16 to Week 24)

Secondary Outcomes (22)

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

  SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)

• Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period

  EEP (Week 16 to Week 24)

• Median Time Spent in the Hemoglobin Range 10.0-12.0 Gram/Deciliter During the Efficacy Evaluation Period

  EEP (Week 16 to Week 24)

• Mean C.E.R.A. Dose Required to Maintain Hemoglobin Level Within the Range 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period

  EEP (Week 16 to Week 20)

• Percentage of Participants Requiring Any Dose Adjustments in C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period

  DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)

Study Arms (1)

C.E.R.A. 120, 200, or 360 mcg

EXPERIMENTAL

Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).

Drug: methoxy polyethylene glycol-epoetin beta

Interventions

methoxy polyethylene glycol-epoetin beta DRUG

120, 200 or 360 micrograms iv every 4 weeks (starting dose)

C.E.R.A. 120, 200, or 360 mcg

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;
• continuous stable iv or sc maintenance epoetin therapy during previous 4 weeks;
• 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 requiring hospitalization or interruption of epoetin treatment in previous 6 months;
• significant acute or chronic bleeding.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (20)

Cukurova University Medical Faculty; Internal Medicine

Adana, 01330, Turkey (Türkiye)

Location

Ankara Research and Training Hospital; The Clinic of Nephrology

Ankara, 06100, Turkey (Türkiye)

Location

Ankara University School of Medicine; Nephrology

Ankara, 06100, Turkey (Türkiye)

Location

Faith University School of Medicine; Nephrology

Ankara, 06100, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty; Department of Internal Medicine

Ankara, 06100, Turkey (Türkiye)

Location

Baskent University Hospital; Transplantation

Ankara, 06490, Turkey (Türkiye)

Location

Gazi University School of Medicine; Nephrology

Ankara, 06500, Turkey (Türkiye)

Location

Adnan Menderes Uni School of Medicine; Physical Therapy & Rehabilitation

Aydin, 09100, Turkey (Türkiye)

Location

Dicle Uni Medical Faculty; Internal Medicine

Diyarbakır, 10000, Turkey (Türkiye)

Location

Trakya University Medical Faculty; Internal Medicine; Nephrology

Edirne, 22030, Turkey (Türkiye)

Location

Firat Uni School Of Medicine; Nephrology

Elâzığ, 23110, Turkey (Türkiye)

Location

Ataturk University Medical Faculty; Department of Internal Medicine

Erzurum, 25240, Turkey (Türkiye)

Location

Sisli Etfal Research and Training Hospital; The Clinic of Nephrology

Istanbul, 34377, Turkey (Türkiye)

Location

Istanbul University Istanbul Medical Faculty; Department of Internal Medicine

Istanbul, 34390, Turkey (Türkiye)

Location

Marmara Uni School of Medicine; Nephrology

Istanbul, 34662, Turkey (Türkiye)

Location

Izmir Ataturk Research and Training Hospital; The Clinic of Nephrology

Izmir, 35290, Turkey (Türkiye)

Location

Dokuz Eylul University School of Medicine; Nephrology

Izmir, Turkey (Türkiye)

Location

Erciyes University School of Medicine; Nephrology

Kayseri, 38039, Turkey (Türkiye)

Location

Inonu Uni School of Medicine

Malatya, 44300, Turkey (Türkiye)

Location

Mersin University Medical Faculty

Mersin, 33169, Turkey (Türkiye)

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

Limitations and Caveats

Low number of participants completed the study as per the protocol. Administration of iron (oral/IV) was as per discretion of individual centers; therefore, C.E.R.A. responses have been limited by iron levels too low for efficient erythropoiesis.

Results Point of Contact

• 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: April 16, 2008
• First Posted: April 18, 2008
• Study Start: May 14, 2008
• Primary Completion: June 22, 2010
• Study Completion: June 22, 2010
• Last Updated: December 6, 2017
• Results First Posted: July 19, 2016

Record last verified: 2017-11

Locations

TU (20)