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

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

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Bangalore, India, 560017
    • Manipal Institute of Nephrology and Urology; Nephrology
  • Bangalore, India, 560024
    • Columbia Asia Medical Centre - Hebbal; Nephrology
  • Chennai, India, 600 037
    • Tanker Foundation
  • Chennai, India, 6000089
    • MIOT Institute of Nephrology ; Nephrology
  • Chennai, India, 600037
    • Madras Medical Mission Hospital
  • Guwahati, India, 781005
    • International Hospital
  • Hyderabad, India, 500068
    • Kamineni Hospitals; Nephrology
  • Hyderabad, India, 500082
    • Nizam's Institute of Medical Sciences; Nephrology
  • Kanpur, India, 208005
    • Regency Hospital Ltd.; Nephrology
  • Kolkata, India, 700029
    • Wockhardt Hospital and Kidney Institute; Nephrology
  • Meerut, India, 250001
    • Meerut Kidney Hospital
  • Mohali, India, 160 063
    • Silver Oaks Hospital; Nephrology
  • Mumbai, India, 400080
    • Apex Kidney Care
  • Mumbai, India, 400092
    • Lancelot Dialysis Center
  • New Delhi, India, 110070
    • Fortis Flt. Lt. Rajan Dhall Hospital; Nephrology
  • Pune, India, 411 001
    • Ruby Hall Clinic
  • Delhi
    • New Delhi, Delhi, India, 110076
      • Indraprastha Apollo Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mircera; Participant with chronic renal anemia will receive methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.	Drug: methoxy polyethylene glycol-epoetin beta [Mircera]; iv (120, 200 or 360 micrograms) every 4 weeks for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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
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
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
Number of Participants With Abnormal Electrocardiogram	Participants with abnormal electrocardiogram were reported.	At Week -2 and Week 12
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
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
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
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
Mean Values of Serum Ferritin Over Time	Mean values of serum ferritin were reported.	At Weeks -2, 4, 8, and 12
Mean Values of Transferrin Over Time	Mean values of transferrin were reported.	At Weeks -2, 4, 8, and 12
Mean Values of Transferrin Saturation Over Time	Mean values of Transferrin Saturation (TSAT) were reported.	At Weeks -2, 4, 8, and 12
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
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
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
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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2008
• Primary Completion (Actual): September 12, 2009
• Study Completion (Actual): September 12, 2009

Study Registration Dates

• First Submitted: August 18, 2008
• First Submitted That Met QC Criteria: August 18, 2008
• First Posted (Estimate): August 19, 2008

Study Record Updates

• Last Update Posted (Actual): December 7, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML21810

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No