Clinical trial NCT00559637: A Study of Subcutaneous Mircera in Participants With Chronic Kidney Disease Not Treated With ESA or on Dialysis
Official title: Single-arm, Open Study to Investigate the Efficacy, Safety and Tolerability of Monthly Subcutaneously Administered C.E.R.A. in Patients With Renal Anemia Not Yet Subject to Dialysis and Not Yet Permanently Treated With ESAs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-11-16
Enrollment: 184
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 subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not treated with erythropoiesis stimulating agent (ESA) and not on dialysis. Eligible participants will receive Mircera by monthly subcutaneous injections. The initial dose, based on body weight, will be 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment is 9-11 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* chronic renal anemia;
* hemoglobin value less than or equal to (\<=) 10.5 grams/deciliter (g/dL).

Exclusion Criteria:

* prior ESA therapy during previous 3 months;
* acute or chronic bleeding requiring therapy during previous 2 months;
* transfusion of red blood cells during previous 2 months;
* active malignant disease (except non-melanoma skin cancer).

Primary outcomes:
measure: Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-12 Grams Per Deciliter (g/dL)
timeFrame: Evaluation phase (Months 8 and 9)
measure: Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-13 g/dL
timeFrame: Evaluation phase (Months 8 and 9)
measure: Change From Baseline in Hemoglobin Value to the Evaluation Phase
timeFrame: Baseline, evaluation phase (Months 8 and 9)
Secondary outcomes:
measure: Duration of Hemoglobin Values in the Range of 11-12 g/dL
timeFrame: Baseline to Month 9
measure: Duration of Hemoglobin Values in the Range of 11-13 g/dL
timeFrame: Baseline to Month 9
measure: Time to Increase of Hemoglobin Value to Over 11 g/dL
timeFrame: Baseline to Month 9
measure: Total Number of Dose Adjustments
timeFrame: Baseline until Month 8
measure: Total Number of Red Blood Cell (RBC) Transfusions
timeFrame: Baseline to Month 9
Other outcomes:
Locations:
city: Ansbach
country: Germany
city: Arnsberg
country: Germany
city: Bad Aibling
country: Germany
city: Bad Malente
country: Germany
city: Berlin
country: Germany
city: Bischofswerda
country: Germany
city: Bonn
country: Germany
city: Dieburg
country: Germany
city: Dortmund
country: Germany
city: Düsseldorf
country: Germany
city: Emsdetten
country: Germany
city: Frankfurt
country: Germany
city: Friedberg
country: Germany
city: Grimma
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Heidelberg
country: Germany
city: Hilden
country: Germany
city: Homburg
country: Germany
city: Hoyerswerda
country: Germany
city: Jena
country: Germany
city: Kaiserslautern
country: Germany
city: Koeln
country: Germany
city: Köln
country: Germany
city: Ludwigslust
country: Germany
city: Lörrach
country: Germany
city: Lübeck
country: Germany
city: Lünen
country: Germany
city: Mainz
country: Germany
city: Mettmann
country: Germany
city: Mühlacker
country: Germany
city: München
country: Germany
city: Regensburg
country: Germany
city: Rheine
country: Germany
city: Saarlouis
country: Germany
city: Schwandorf
country: Germany
city: Schweinfurt
country: Germany
city: Sindelfingen
country: Germany
city: Sinsheim
country: Germany
city: Tangermünde
country: Germany
city: Trier
country: Germany
city: Tübingen
country: Germany
city: ULM
country: Germany
city: Velbert
country: Germany
city: Wetzlar
country: Germany
city: Wiesloch
country: Germany
city: Worms
country: Germany
city: Wuerzburg
country: Germany
city: Würzburg
country: Germany
city: Zwickau
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: