A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00413894

First Posted: December 20, 2006

Last Update Posted: February 15, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Hoffmann-La Roche

Tracking Information

First Submitted Date ^ICMJE

December 19, 2006

First Posted Date ^ICMJE

December 20, 2006

Results First Submitted Date

January 17, 2016

Results First Posted Date

February 15, 2016

Last Update Posted Date

February 15, 2016

Start Date ^ICMJE

March 2007

Primary Completion Date

October 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase [ Time Frame: Visits 8 to 10 (Months 6 to 8) ]
Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase [ Time Frame: Visits 8 to 10 (Months 6 to 8) ]
Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase [ Time Frame: Visits 8 to 10 (Months 6 to 8) ]
Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.
Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase [ Time Frame: Visits 8 to 10 (Months 6 to 8) ]
Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.

Original Primary Outcome Measures ^ICMJE

Percentage of patients in a defined Hb range during evaluation period; percentage of patients with or without dose adjustments during evaluation period.

Change History

Complete list of historical versions of study NCT00413894 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase [ Time Frame: Visits 1 to 2 (Months -2 to -1) ]
Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase [ Time Frame: Visits 1 to 2 (Months -2 to -1) ]
Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase [ Time Frame: Visits 1 to 2 (Months -2 to -1) ]
Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.
Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase [ Time Frame: Visits 1 to 2 (Months -2 to -1) ]
Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.
Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels [ Time Frame: Visits 1 to 2 (Months -2 to -1) and Visits 8 to 10 (Months 6 to 8) ]
Shifts in Hb levels between Screening and Evaluation Phase were classified as follows: Category A: Participants with Hb levels in both Screening and Evaluation Phase within 10-13 g/dL; Category B: Participants who had Hb values within 10-13 g/dL during Screening but shifted outside the range during Evaluation; Category C: Participants who had Hb values outside range during Screening but shifted to stable values (at least within 10 - 13 g/dL) during Evaluation.; Category D: Participants with less than two values available during Evaluation Phase.

Participants could appear in only 1 category. Participants had to have 2 or 3 values within range (depending on the number of measurements available) to be counted.
Percentage of Participants With Hb Fluctuations Within Evaluation Phase [ Time Frame: Visits 8 to 10 (Months 6 to 8) ]
Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Evaluation Phase) and was categorized as less than or equal to (≤) ±1 g/dL, greater than (>) ±1.0 to ±1.5 g/dL, > ±1.5 to ±2.0 g/dL, and > ±2.0 g/dL. Percentage of participants within these deviation categories were reported for Evaluation Phase of the study.
Percentage of Participants With Hb Fluctuations Within Screening Phase [ Time Frame: Visits 1 to 2 (Months -2 to -1) ]
Hematology and clinical chemistry were performed partially by a central laboratory as well as by the local laboratories by means of their established methods. Normal ranges and methods as well as quality assurance certificates had to be available to the sponsor prior to the start of the study. Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Screening Phase) and was categorized as ≤ ±1 g/dL, >±1.0 to ±1.5 g/dL, >±1.5 to ±2.0 g/dL, and >±2.0 g/dL. Percentage of participants within these deviation categories are reported for Screening Phase of the study.
Percentage of Participants Requiring Erythrocyte Transfusions [ Time Frame: Visits 1 to 10 (Months -2 to 8) ]

Original Secondary Outcome Measures ^ICMJE

Efficacy: percentage of patients in a defined range, and with or without dose adjustments, during screening period; incidence of RBC transfusions. Safety: AEs, lab parameters, vital signs.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.

Official Title ^ICMJE

An Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Levels in Anemic Patients With Chronic Kidney Disease Who Are on Dialysis, and Who Have Previously Received Epoetin Alfa or Beta or Darbepoetin Alfa Treatment.

Brief Summary

This single arm study will assess the efficacy and safety of intravenous Mircera, administered with pre-filled syringes, for the treatment of anemia in patients with chronic kidney disease who are on dialysis, and who have previously received treatment with epoetin alfa or beta or darbepoetin alfa. Patients will receive monthly intravenous injections of Mircera, with the starting dose derived from the dose of epoetin alfa or beta or darbepoetin 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 500+ individuals.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Anemia

Intervention ^ICMJE

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

iv monthly, with starting dose based on previous dose of epoetin alfa or beta or darbepoetin alfa

Study Arms

Experimental: 1

Intervention: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Publications *

Fliser D, Kleophas W, Dellanna F, Winkler RE, Backs W, Kraatz U, Fassbinder W, Wizemann V, Strack G. Evaluation of maintenance of stable haemoglobin levels in haemodialysis patients converting from epoetin or darbepoetin to monthly intravenous C.E.R.A.: the MIRACEL study. Curr Med Res Opin. 2010 May;26(5):1083-9. doi: 10.1185/03007991003666652. Erratum in: Curr Med Res Opin. 2010 Aug;26(8):1826. Dellana, F [corrected to Dellanna, F].

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

424

Completion Date

October 2008

Primary Completion Date

October 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

adult patients, >=18 years of age;
chronic renal anemia;
longterm hemodialysis for >=12 weeks before screening;
baseline Hb between 10 and 13g/dL;
iv or sc maintenance epoetin alfa or beta or darbepoetin alfa therapy with same dosing interval for >=4 weeks before screening.

Exclusion Criteria:

acute or chronic bleeding within 8 weeks prior to screening;
transfusion of red blood cells within 8 weeks prior to screening;
poorly controlled hypertension necessitating interruption of erythropoetin treatment in previous 6 months;
previous treatment with Mircera.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Germany

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00413894

Other Study ID Numbers ^ICMJE

ML20572

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

PRS Account

Hoffmann-La Roche

Verification Date

January 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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