Clinical trial NCT00661388: A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA.
Official title: A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anaemia in Pre-dialysis Patients Not Currently Treated With ESA.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 75
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 methoxy polyethylene glycol-epoetin beta (Mircera) for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with erythropoietin stimulating agents (ESA). Eligible patients will receive monthly subcutaneous injections of Mircera 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;
* predialysis stage;
* no ESA therapy during previous 3 months.

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 the Efficacy Evaluation Period
timeFrame: From Baseline (Week 0) to EEP (Week 29 to Week 36)
Secondary outcomes:
measure: Mean Time to Achievement of Response During the EEP
timeFrame: From Week 29 to Week 36
measure: The Percentage of Participants Whose Hb Concentrations Remained Within the Target Range of 10.0- 12.0 g/dLThroughout the EEP
timeFrame: From Week 29 to Week 36
measure: Mean Time Spent by Participants in the Target Range of 10.0- 12.0 g/dL During the EEP
timeFrame: From Week 29 to Week 36
measure: Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP
timeFrame: Weeks 0 to Week 36
measure: Number of Participants Who Received Red Blood Cell Transfusions During the Study Period
timeFrame: Up to Week 52
measure: Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events
timeFrame: Up to Week 52
measure: Mean Change From Baseline in Hb Concentration Over Time
timeFrame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
measure: Mean Change From Baseline in Hematocrit Level Over Time
timeFrame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
measure: Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Over Time
timeFrame: Baseline (Week 0), Weeks 8, 16, 24, 32, and 48
measure: Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time
timeFrame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
measure: Mean Change From Baseline in Albumin Concentration Over Time
timeFrame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
measure: Mean Change From Baseline in C-Reactive Protein Concentration Over Time
timeFrame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
measure: Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time
timeFrame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
measure: Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time
timeFrame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
measure: Mean Change From Baseline in Creatinine Concentration Over Time
timeFrame: Baseline (Week 0), Weeks 8, 16, 32, 40
measure: Mean Change From Baseline in Ferritin Concentration Over Time
timeFrame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
measure: Mean Change From Baseline in Transferrin Saturation Over Time
timeFrame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
Other outcomes:
Locations:
city: Ankara
country: Turkey
city: Denizli
country: Turkey
city: Edirne
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Kahramanmaras
country: Turkey
city: Konya
country: Turkey
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: