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

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
Study Start Date ICMJE	March 2007
Actual Primary Completion Date	October 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 17, 2016)	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; (submitted: December 19, 2006)	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; (submitted: January 17, 2016)	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; (submitted: December 19, 2006)	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 *	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.; 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
Actual Enrollment ICMJE; (submitted: January 17, 2016)	424
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	October 2008
Actual 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, Older Adult)
Accepts Healthy Volunteers	No
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