Clinical trial NCT00413894: A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-12-20
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase
timeFrame: Visits 8 to 10 (Months 6 to 8)
measure: Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase
timeFrame: Visits 8 to 10 (Months 6 to 8)
measure: Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase
timeFrame: Visits 8 to 10 (Months 6 to 8)
measure: Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase
timeFrame: Visits 8 to 10 (Months 6 to 8)
Secondary outcomes:
measure: Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase
timeFrame: Visits 1 to 2 (Months -2 to -1)
measure: Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase
timeFrame: Visits 1 to 2 (Months -2 to -1)
measure: Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase
timeFrame: Visits 1 to 2 (Months -2 to -1)
measure: Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase
timeFrame: Visits 1 to 2 (Months -2 to -1)
measure: Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels
timeFrame: Visits 1 to 2 (Months -2 to -1) and Visits 8 to 10 (Months 6 to 8)
measure: Percentage of Participants With Hb Fluctuations Within Evaluation Phase
timeFrame: Visits 8 to 10 (Months 6 to 8)
measure: Percentage of Participants With Hb Fluctuations Within Screening Phase
timeFrame: Visits 1 to 2 (Months -2 to -1)
measure: Percentage of Participants Requiring Erythrocyte Transfusions
timeFrame: Visits 1 to 10 (Months -2 to 8)
Other outcomes:
Locations:
city: Aachen
country: Germany
city: Aachen
country: Germany
city: Alzey
country: Germany
city: Ansbach
country: Germany
city: Augsburg
country: Germany
city: Bad König
country: Germany
city: Bad Neundorf
country: Germany
city: Bad Oeynhausen
country: Germany
city: Bad Orb
country: Germany
city: Bayreuth
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Bottrop
country: Germany
city: Bovenden
country: Germany
city: Braunschweig
country: Germany
city: Bremen
country: Germany
city: Coesfeld
country: Germany
city: Darmstadt
country: Germany
city: Darmstadt
country: Germany
city: Daun
country: Germany
city: Demmin
country: Germany
city: Dessau
country: Germany
city: Dortmund
country: Germany
city: Düsseldorf
country: Germany
city: Düsseldorf
country: Germany
city: Düsseldorf
country: Germany
city: Erfurt
country: Germany
city: Essen
country: Germany
city: Frankfurt Am Main
country: Germany
city: Freiburg
country: Germany
city: Freiburg
country: Germany
city: Freudenstadt
country: Germany
city: Fulda
country: Germany
city: Fürstenzell
country: Germany
city: Fürth
country: Germany
city: Gelsenkirchen
country: Germany
city: Gelsenkirchen
country: Germany
city: Gerolstein
country: Germany
city: Giessen
country: Germany
city: Greifswald
country: Germany
city: Göttingen
country: Germany
city: Gütersloh
country: Germany
city: Halle
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Hann. Münden
country: Germany
city: Harsewinkel
country: Germany
city: Heidelberg
country: Germany
city: Heide
country: Germany
city: Heilbronn
country: Germany
city: Hildesheim
country: Germany
city: Homburg/saar
country: Germany
city: Homburg
country: Germany
city: Idar-oberstein
country: Germany
city: Jena
country: Germany
city: Karlsruhe
country: Germany
city: Kiel
country: Germany
city: Krefeld
country: Germany
city: Köln
country: Germany
city: Lauterbach
country: Germany
city: Leipzig
country: Germany
city: Leipzig
country: Germany
city: Lennestadt
country: Germany
city: Ludwigsburg
country: Germany
city: Ludwigshafen
country: Germany
city: Lüdenscheid
country: Germany
city: Marburg
country: Germany
city: Marl
country: Germany
city: Meiningen
country: Germany
city: Memmingen
country: Germany
city: Minden
country: Germany
city: Mönchengladbach
country: Germany
city: München
country: Germany
city: Neuruppin
country: Germany
city: Oberschleissheim
country: Germany
city: Offenbach
country: Germany
city: Offenburg
country: Germany
city: Potsdam
country: Germany
city: Recklinghausen
country: Germany
city: Regensburg
country: Germany
city: Reutlingen
country: Germany
city: Ribnitz-damgarten
country: Germany
city: Rostock
country: Germany
city: Rostock
country: Germany
city: Saarbrücken
country: Germany
city: Schloss Holte-stutenbrock
country: Germany
city: Schwerin
country: Germany
city: Schwerin
country: Germany
city: Schwetzingen
country: Germany
city: Stralsund
country: Germany
city: Stuttgart
country: Germany
city: Stuttgart
country: Germany
city: Trier
country: Germany
city: Waiblingen
country: Germany
city: Weinheim
country: Germany
city: Weinheim
country: Germany
city: Wiesbaden
country: Germany
city: Wiesloch
country: Germany
city: Wuppertal
country: Germany
city: Wuppertal
country: Germany
city: Würzburg
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.