Clinical trial NCT00680563: A Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently Treated With ESA.
Official title: An Open Label Study of the Safety, Tolerability and Effect on Hemoglobin Levels of Once-monthly Subcutaneous Mircera in Predialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-05-20
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic renal anemia;
* no ESA therapy during previous 3 months;
* adequate iron status;
* rapid chronic kidney disease progression.

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months;
* poorly controlled hypertension requiring hospitalization in previous 6 months;
* significant acute or chronic bleeding.

Primary outcomes:
measure: Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP).
timeFrame: Week 32
Secondary outcomes:
measure: Time to achievement of response
timeFrame: Throughout study
measure: Percentage of patients whose Hb concentration remains within range 10.0-12.0g/dL
timeFrame: Throughout study
measure: Percentage of patients whose average Hb concentration is within range 10.0 - 12.0g/dL
timeFrame: Throughout study
measure: Mean time spent in Hb range of 10.0 - 12.0g/dL
timeFrame: Throughout study
measure: Percentage of patients requiring dose adjustments; incidence of RBC transfusions; time to initiation of renal replacement therapy.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: La Plata
country: Argentina
city: Tucuman
country: Argentina
city: Blumenau
country: Brazil
city: Botucatu
country: Brazil
city: Curitiba
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Santiago de Chile
country: Chile
city: Santiago
country: Chile
city: Barranquilla
country: Colombia
city: Cali
country: Colombia
city: Envigado
country: Colombia
city: Medellin
country: Colombia
city: San Jose
country: Costa Rica
city: Quito
country: Ecuador
city: Guatemala City
country: Guatemala
city: Panama City
country: Panama
city: Lima
country: Peru
city: San Isidro
country: Peru
city: Caracas
country: Venezuela
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: