Clinical trial NCT00737711: A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.
Official title: A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Two Weekly Administration of Intravenous Methoxy Polyethylene Glycol-epoetin Beta (MIRCERA) for the Treatment of Chronic Renal Anemia in Dialysis Patients Not Currently Treated With Erythropoietin-stimulating Agent (ESA).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-08-19
Enrollment: 189
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 evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks with follow up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* male or female patients, \>=18 years of age;
* chronic renal anemia (Hb concentration 8.0g/dL - 10.0g/dL);
* no prior erythropoietin stimulating agent (ESA) therapy.

Exclusion Criteria:

* blood transfusion within the previous 4 weeks;
* poorly controlled hypertension;
* significant acute or chronic bleeding;
* active malignant disease;
* congestive heart failure (NYHA Class IV).

Primary outcomes:
measure: Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period
timeFrame: Baseline (Week 0) and Week 16
Secondary outcomes:
measure: Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter
timeFrame: Up to Week 16
measure: Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16
timeFrame: Week 12 to Week 16
measure: Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16
timeFrame: Week 12 to Week 16
measure: Number of Participants With Adverse Events, Serious Adverse Events and Deaths
timeFrame: Up to Week 18
measure: Number of Participants With Abnormal Electrocardiogram
timeFrame: Up to Week 16
measure: Number of Participants With Reports of Blood Transfusions
timeFrame: Up to Week 16
measure: Number of Participants With Reports of Anti-Epoetin Antibodies
timeFrame: Up to Week 16
measure: Mean White Blood Cell Count Over Time
timeFrame: Baseline (Week 0), Week 4, Week 10, and Week 16
measure: Mean Value of Mean Corpuscular Volume Over Time
timeFrame: Baseline (Week 0), Week 4, Week 10, and Week 16
measure: Mean Hypochromic Red Blood Cells Over Time
timeFrame: Baseline (Week 0), Week 4, Week 10, and Week 16
measure: Mean Platelet Count Over Time
timeFrame: Baseline (Week 0), Week 4, Week 10, and Week 16
measure: Mean Serum Iron Over Time
timeFrame: Baseline (Week 0), Week 4, Week 10, and Week 16
measure: Mean Serum Ferritin Over Time
timeFrame: Baseline (Week 0), Week 4, Week 10, and Week 16
measure: Mean Transferrin Over Time
timeFrame: Baseline (Week 0), Week 4, Week 10, and Week 16
measure: Mean Total Iron-binding Capacity Over Time
timeFrame: Baseline (Week 0), Week 4, Week 10, and Week 16
measure: Mean Transferrin Saturation Over Time
timeFrame: Baseline (Week 0), Week 4, Week 10, and Week 16
measure: Mean Serum Albumin Over Time
timeFrame: Baseline (Week 0), Week 4, Week 10, and Week 16
measure: Mean Serum Globulin Over Time
timeFrame: Baseline (Week 0), Week 4, Week 10, and Week 16
measure: Mean Serum Creatinine Over Time
timeFrame: Baseline (Week 0), Week 4, Week 10, and Week 16
measure: Mean Blood Urea Nitrogen Over Time
timeFrame: Baseline (Week 0), Week 4, Week 10, and Week 16
measure: Mean Serum Potassium Over Time
timeFrame: Baseline (Week 0), Week 4, Week 10, and Week 16
measure: Mean Serum Sodium Over Time
timeFrame: Baseline (Week 0), Week 4, Week 10, and Week 16
measure: Mean Serum Phosphate Over Time
timeFrame: Baseline (Week 0), Week 4, Week 10, and Week 16
measure: Mean Serum Bilirubin Over Time
timeFrame: Baseline (Week 0), Week 4, Week 10, and Week 16
measure: Mean Aspartate Transaminase Over Time
timeFrame: Baseline (Week 0), Week 4, Week 10, and Week 16
measure: Mean Alanine Aminotransferase Over Time
timeFrame: Baseline (Week 0), Week 4, Week 10, and Week 16
measure: Mean Serum Alkaline Phosphatase Over Time
timeFrame: Baseline (Week 0), Week 4, Week 10, and Week 16
Other outcomes:
Locations:
city: Ahmedabad
country: India
city: Bangalore
country: India
city: Chennai
country: India
city: Coimbatore
country: India
city: Gujarat
country: India
city: Hyderabad
country: India
city: Kerala
country: India
city: Kolkata
country: India
city: Ludhiana
country: India
city: Mumbai
country: India
city: Mumbai
country: India
city: New Delhi
country: India
city: New Delhi
country: India
city: New Delhi
country: India
city: Vellore
country: India
city: Vishakpatnam
country: India
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: