Clinical trial NCT00737464: A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
Official title: A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous MIRCERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-08-19
Enrollment: 132
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 maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in dialysis patients with chronic renal anemia. Patients will receive intravenous Mircera (120, 200 or 360 micrograms) every four weeks depending on the previous dose of epoetin alfa administered in the week preceding first study drug administration. Patients will be treated for 12 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 10.5g/dL - 12.5g/dL;
* continuous intravenous maintenance therapy with epoetin alfa at the same dosing interval during the previous 2 months.

Exclusion Criteria:

* blood transfusion within the previous 2 months;
* poorly controlled hypertension;
* significant acute or chronic bleeding;
* active malignant disease;
* congestive heart failure (NYHA Class IV).

Primary outcomes:
measure: Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)
timeFrame: Weeks 8 to 12 (Last 4 weeks of treatment period)
Secondary outcomes:
measure: Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12)
timeFrame: SVP (Weeks -2 to -1) and TP (Weeks 8 to 12)
measure: Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL
timeFrame: Up to Week 12
measure: Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths
timeFrame: Up to Week 14
measure: Mean Change From Baseline in Heart Rate Over Time
timeFrame: From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12
measure: Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
timeFrame: From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12
measure: Number of Participants With Abnormal Electrocardiogram
timeFrame: At Week -2 and Week 12
measure: Mean Values of White Blood Cells and Platelets Over Time
timeFrame: At Weeks -2, 4, 8, and 12
measure: Mean Values of Hypochromic Red Blood Cells Over Time
timeFrame: At Weeks -2, 4, 8, and 12
measure: Mean Corpuscular Volume Levels Over Time
timeFrame: At Weeks -2, 4, 8, and 12
measure: Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time
timeFrame: At Weeks -2, 4, 8, and 12
measure: Mean Values of Serum Ferritin Over Time
timeFrame: At Weeks -2, 4, 8, and 12
measure: Mean Values of Transferrin Over Time
timeFrame: At Weeks -2, 4, 8, and 12
measure: Mean Values of Transferrin Saturation Over Time
timeFrame: At Weeks -2, 4, 8, and 12
measure: Mean Values of Serum Albumin and Serum Globulin Over Time
timeFrame: At Weeks -2, 4, 8, and 12
measure: Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time
timeFrame: At Weeks -2, 4, 8, and 12
measure: Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
timeFrame: At Weeks -2, 4, 8, and 12
measure: Mean Values of Serum Sodium and Serum Potassium Over Time
timeFrame: At Weeks -2, 4, 8, and 12
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Indraprastha Apollo Hospitals
state: Delhi
city: Bangalore
country: India
facility: Manipal Institute of Nephrology and Urology; Nephrology
city: Bangalore
country: India
facility: Columbia Asia Medical Centre - Hebbal; Nephrology
city: Chennai
country: India
facility: Tanker Foundation
city: Chennai
country: India
facility: MIOT Institute of Nephrology ; Nephrology
city: Chennai
country: India
facility: Madras Medical Mission Hospital
city: Guwahati
country: India
facility: International Hospital
city: Hyderabad
country: India
facility: Kamineni Hospitals; Nephrology
city: Hyderabad
country: India
facility: Nizam's Institute of Medical Sciences; Nephrology
city: Kanpur
country: India
facility: Regency Hospital Ltd.; Nephrology
city: Kolkata
country: India
facility: Wockhardt Hospital and Kidney Institute; Nephrology
city: Meerut
country: India
facility: Meerut Kidney Hospital
city: Mohali
country: India
facility: Silver Oaks Hospital; Nephrology
city: Mumbai
country: India
facility: Apex Kidney Care
city: Mumbai
country: India
facility: Lancelot Dialysis Center
city: New Delhi
country: India
facility: Fortis Flt. Lt. Rajan Dhall Hospital; Nephrology
city: Pune
country: India
facility: Ruby Hall Clinic
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: