A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737464
• Other study ID #: ML21810
• Status: Completed
• Phase: Phase 4
• First received: August 18, 2008
• Last updated: November 2, 2017
• Start date: August 26, 2008
• Est. completion date: September 12, 2009

Study information

• Verified date: November 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: September 12, 2009
• Est. primary completion date: September 12, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• methoxy polyethylene glycol-epoetin beta [Mircera]
iv (120, 200 or 360 micrograms) every 4 weeks for 12 weeks.

Locations

Country	Name	City	State
India	Columbia Asia Medical Centre - Hebbal; Nephrology	Bangalore
India	Manipal Institute of Nephrology and Urology; Nephrology	Bangalore
India	Madras Medical Mission Hospital	Chennai
India	MIOT Institute of Nephrology ; Nephrology	Chennai
India	Tanker Foundation	Chennai
India	International Hospital	Guwahati
India	Kamineni Hospitals; Nephrology	Hyderabad
India	Nizam's Institute of Medical Sciences; Nephrology	Hyderabad
India	Regency Hospital Ltd.; Nephrology	Kanpur
India	Wockhardt Hospital and Kidney Institute; Nephrology	Kolkata
India	Meerut Kidney Hospital	Meerut
India	Silver Oaks Hospital; Nephrology	Mohali
India	Apex Kidney Care	Mumbai
India	Lancelot Dialysis Center	Mumbai
India	Fortis Flt. Lt. Rajan Dhall Hospital; Nephrology	New Delhi
India	Indraprastha Apollo Hospitals	New Delhi	Delhi
India	Ruby Hall Clinic	Pune

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)	Participants maintaining mean hemoglobin (Hb) concentration within the target range i.e. 10.0 - 12.0 gram per deciliter (g/dL) during last 4 weeks (Weeks 8 to 12) of treatment period (TP) were reported. Total duration for treatment period was 12 weeks. Stability verification period of 2-weeks was conducted before treatment period. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value Hb +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.	Weeks 8 to 12 (Last 4 weeks of treatment period)
Secondary	Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12)	The mean change in Hb concentration between reference stability verification period (SVP) and in last 4 weeks (Weeks 8 to 12) of treatment period (TP) was reported. Duration for SVP was 2 weeks followed by treatment period of 12 weeks. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.	SVP (Weeks -2 to -1) and TP (Weeks 8 to 12)
Secondary	Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL	Mean time participants spent having hemoglobin range of 10.0 to 12.0 g/dL was reported. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 gram per deciliter but not >12.0 g/dL and not <10.0 g/dL.	Up to Week 12
Secondary	Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths	Participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and deaths in the overall study were reported. An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	Up to Week 14
Secondary	Mean Change From Baseline in Heart Rate Over Time	Mean change from Baseline (Week -1) to end of the treatment (Week 12) in heart rate was reported. Baseline measure was considered as (Week -1) evaluation for this parameter.	From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12
Secondary	Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time	Mean change from Baseline (Week -2) to end of the treatment (Week 12) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) before and after dialysis was reported. Baseline measure was considered as (Week -2) evaluation for this parameter.	From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12
Secondary	Number of Participants With Abnormal Electrocardiogram	Participants with abnormal electrocardiogram were reported.	At Week -2 and Week 12
Secondary	Mean Values of White Blood Cells and Platelets Over Time	Mean values of white blood cells (WBCs), and platelets at Weeks -2, 4, 8, and 12 were reported.	At Weeks -2, 4, 8, and 12
Secondary	Mean Values of Hypochromic Red Blood Cells Over Time	Mean values of hypochromic red blood cells (RBCs) at Weeks -2, 4, 8, and 12 were reported.	At Weeks -2, 4, 8, and 12
Secondary	Mean Corpuscular Volume Levels Over Time	Mean corpuscular volume (MCV) is a measure of the average red blood cell volume. MCV levels at Weeks -2, 4, 8, and 12 were reported.	At Weeks -2, 4, 8, and 12
Secondary	Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time	Mean values of serum iron and total iron binding capacity (TIBC) were reported.	At Weeks -2, 4, 8, and 12
Secondary	Mean Values of Serum Ferritin Over Time	Mean values of serum ferritin were reported.	At Weeks -2, 4, 8, and 12
Secondary	Mean Values of Transferrin Over Time	Mean values of transferrin were reported.	At Weeks -2, 4, 8, and 12
Secondary	Mean Values of Transferrin Saturation Over Time	Mean values of Transferrin Saturation (TSAT) were reported.	At Weeks -2, 4, 8, and 12
Secondary	Mean Values of Serum Albumin and Serum Globulin Over Time	Mean values of serum albumin and serum globulin were reported.	At Weeks -2, 4, 8, and 12
Secondary	Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time	Mean values of aspartate aminotransferase (AST), alanine transaminase (ALT) and serum alkaline phosphatase were reported.	At Weeks -2, 4, 8, and 12
Secondary	Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time	Mean values of serum creatinine, blood urea nitrogen (BUN), serum phosphate and serum bilirubin were reported.	At Weeks -2, 4, 8, and 12
Secondary	Mean Values of Serum Sodium and Serum Potassium Over Time	Mean values of serum sodium and serum potassium were reported.	At Weeks -2, 4, 8, and 12