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

Primary Purpose

Anemia

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
methoxy polyethylene glycol-epoetin beta [Mircera]
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Indraprastha Apollo Hospitals
  • Manipal Institute of Nephrology and Urology; Nephrology
  • Columbia Asia Medical Centre - Hebbal; Nephrology
  • Tanker Foundation
  • MIOT Institute of Nephrology ; Nephrology
  • Madras Medical Mission Hospital
  • International Hospital
  • Kamineni Hospitals; Nephrology
  • Nizam's Institute of Medical Sciences; Nephrology
  • Regency Hospital Ltd.; Nephrology
  • Wockhardt Hospital and Kidney Institute; Nephrology
  • Meerut Kidney Hospital
  • Silver Oaks Hospital; Nephrology
  • Apex Kidney Care
  • Lancelot Dialysis Center
  • Fortis Flt. Lt. Rajan Dhall Hospital; Nephrology
  • Ruby Hall Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mircera

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
Number of Participants With Abnormal Electrocardiogram
Participants with abnormal electrocardiogram were reported.
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.
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.
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.
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.
Mean Values of Serum Ferritin Over Time
Mean values of serum ferritin were reported.
Mean Values of Transferrin Over Time
Mean values of transferrin were reported.
Mean Values of Transferrin Saturation Over Time
Mean values of Transferrin Saturation (TSAT) were reported.
Mean Values of Serum Albumin and Serum Globulin Over Time
Mean values of serum albumin and serum globulin were reported.
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.
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.
Mean Values of Serum Sodium and Serum Potassium Over Time
Mean values of serum sodium and serum potassium were reported.

Full Information

First Posted
August 18, 2008
Last Updated
November 2, 2017
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00737464
Brief Title
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 26, 2008 (Actual)
Primary Completion Date
September 12, 2009 (Actual)
Study Completion Date
September 12, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mircera
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention Description
iv (120, 200 or 360 micrograms) every 4 weeks for 12 weeks.
Primary Outcome Measure Information:
Title
Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)
Description
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.
Time Frame
Weeks 8 to 12 (Last 4 weeks of treatment period)
Secondary Outcome Measure Information:
Title
Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12)
Description
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.
Time Frame
SVP (Weeks -2 to -1) and TP (Weeks 8 to 12)
Title
Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL
Description
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.
Time Frame
Up to Week 12
Title
Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths
Description
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.
Time Frame
Up to Week 14
Title
Mean Change From Baseline in Heart Rate Over Time
Description
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.
Time Frame
From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12
Title
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
Description
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.
Time Frame
From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12
Title
Number of Participants With Abnormal Electrocardiogram
Description
Participants with abnormal electrocardiogram were reported.
Time Frame
At Week -2 and Week 12
Title
Mean Values of White Blood Cells and Platelets Over Time
Description
Mean values of white blood cells (WBCs), and platelets at Weeks -2, 4, 8, and 12 were reported.
Time Frame
At Weeks -2, 4, 8, and 12
Title
Mean Values of Hypochromic Red Blood Cells Over Time
Description
Mean values of hypochromic red blood cells (RBCs) at Weeks -2, 4, 8, and 12 were reported.
Time Frame
At Weeks -2, 4, 8, and 12
Title
Mean Corpuscular Volume Levels Over Time
Description
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.
Time Frame
At Weeks -2, 4, 8, and 12
Title
Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time
Description
Mean values of serum iron and total iron binding capacity (TIBC) were reported.
Time Frame
At Weeks -2, 4, 8, and 12
Title
Mean Values of Serum Ferritin Over Time
Description
Mean values of serum ferritin were reported.
Time Frame
At Weeks -2, 4, 8, and 12
Title
Mean Values of Transferrin Over Time
Description
Mean values of transferrin were reported.
Time Frame
At Weeks -2, 4, 8, and 12
Title
Mean Values of Transferrin Saturation Over Time
Description
Mean values of Transferrin Saturation (TSAT) were reported.
Time Frame
At Weeks -2, 4, 8, and 12
Title
Mean Values of Serum Albumin and Serum Globulin Over Time
Description
Mean values of serum albumin and serum globulin were reported.
Time Frame
At Weeks -2, 4, 8, and 12
Title
Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time
Description
Mean values of aspartate aminotransferase (AST), alanine transaminase (ALT) and serum alkaline phosphatase were reported.
Time Frame
At Weeks -2, 4, 8, and 12
Title
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
Description
Mean values of serum creatinine, blood urea nitrogen (BUN), serum phosphate and serum bilirubin were reported.
Time Frame
At Weeks -2, 4, 8, and 12
Title
Mean Values of Serum Sodium and Serum Potassium Over Time
Description
Mean values of serum sodium and serum potassium were reported.
Time Frame
At Weeks -2, 4, 8, and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Indraprastha Apollo Hospitals
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110076
Country
India
Facility Name
Manipal Institute of Nephrology and Urology; Nephrology
City
Bangalore
ZIP/Postal Code
560017
Country
India
Facility Name
Columbia Asia Medical Centre - Hebbal; Nephrology
City
Bangalore
ZIP/Postal Code
560024
Country
India
Facility Name
Tanker Foundation
City
Chennai
ZIP/Postal Code
600 037
Country
India
Facility Name
MIOT Institute of Nephrology ; Nephrology
City
Chennai
ZIP/Postal Code
6000089
Country
India
Facility Name
Madras Medical Mission Hospital
City
Chennai
ZIP/Postal Code
600037
Country
India
Facility Name
International Hospital
City
Guwahati
ZIP/Postal Code
781005
Country
India
Facility Name
Kamineni Hospitals; Nephrology
City
Hyderabad
ZIP/Postal Code
500068
Country
India
Facility Name
Nizam's Institute of Medical Sciences; Nephrology
City
Hyderabad
ZIP/Postal Code
500082
Country
India
Facility Name
Regency Hospital Ltd.; Nephrology
City
Kanpur
ZIP/Postal Code
208005
Country
India
Facility Name
Wockhardt Hospital and Kidney Institute; Nephrology
City
Kolkata
ZIP/Postal Code
700029
Country
India
Facility Name
Meerut Kidney Hospital
City
Meerut
ZIP/Postal Code
250001
Country
India
Facility Name
Silver Oaks Hospital; Nephrology
City
Mohali
ZIP/Postal Code
160 063
Country
India
Facility Name
Apex Kidney Care
City
Mumbai
ZIP/Postal Code
400080
Country
India
Facility Name
Lancelot Dialysis Center
City
Mumbai
ZIP/Postal Code
400092
Country
India
Facility Name
Fortis Flt. Lt. Rajan Dhall Hospital; Nephrology
City
New Delhi
ZIP/Postal Code
110070
Country
India
Facility Name
Ruby Hall Clinic
City
Pune
ZIP/Postal Code
411 001
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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