Back to resultsA Study of Subcutaneous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
methoxy polyethylene glycol-epoetin beta [Mircera]
Epoetin alfa
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
Inclusion Criteria:
- adult patients, >=18 years of age;
- chronic renal anemia;
- regular hemodialysis with the same schedule of dialysis for >=12 weeks;
- maintenance therapy with subcutaneous epoetin alfa at the same administration interval for 4 weeks.
Exclusion Criteria:
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring interruption of epoetin alfa in previous 6 months;
- acute or chronic bleeding;
- active malignant disease (except non-melanoma skin cancer).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants Maintaining Their Mean Hemoglobin Concentration Within Plus or Minus 1 Gram/Deciliter of Their Reference Hemoglobin and Between the Target Range During Efficacy Evaluation Period
The target hemoglobin (Hb) range was defined as Hb concentration (gram/deciliter [g/dL]) between 10.5 and 12.5 g/dL during the efficacy evaluation period (EEP). EEP was from Week 29 to Week 36.
Secondary Outcome Measures
Mean Change From Baseline in Hemoglobin Concentration Between Baseline and at the Efficacy Evaluation Period
The Baseline (Safety Verification Period) was from Week - 4 to Week -1.
Percentage of Participants Maintaining Individual Hemoglobin Concentration Within the Range of 10.5 - 12.5 Gram/Decilitre Throughout the Efficacy Evaluation Period
Percentage of participants maintaining individual Hb concentration within the Hb range 10.5 - 12.5 g/dL were reported during EEP. The EEP was from Week 29 to Week 36 of the study period.
Mean Time Spent in Hemoglobin Range of 10.5 - 12.5 Gram/Decilitre During the Efficacy Evaluation Period
Mean time to maintain Hb in the range of 10.5-12.5 g/dL during EEP is presented.
Number of Participants Who Required Dose Adjustments During the Dose Titration Period
The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28.
Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period
The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Efficacy Evaluation Period (EEP). The EEP was from Week 29 to Week 36.
Number of Participants Received Red Blood Cells Transfusions
The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported. For this study, blood transfusion was reported during the titration period. No transfusion occurred in the EEP.
Mean Values of Hemoglobin Concentration at Baseline and Week 36
The mean Hb concentration for each participant throughout the study was estimated. Summary data of mean values of Hb concentration at Baseline and Week 36 are presented.
Mean Values of Hematocrit at Baseline and Week 36
Hematocrit is the volume percentage of red blood cells in blood. The mean hematocrit for each participant was estimated throughout the study. Summary data of mean values of Hb at Baseline and Week 36 are presented.
Mean Values of Mean Corpuscular Volume at Baseline and Week 36
Mean corpuscular volume (MCV) is the average volume of red cells. The mean MCV concentration for each participant throughout the study was estimated. Summary data of mean values of MCV concentration at Baseline and Week 36 are presented.
Mean Values of Leukocytes and Platelets Count at Baseline and Week 36
The mean values of laboratory parameters: leukocytes and platelets count for each participant was estimated throughout the study. Summary data of mean values of leukocytes and platelets count at Baseline and Week 36 are presented.
Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36
Mean values of laboratory parameters: creatinine, potassium, phosphate, parathyroid hormone (PTH), iron and total iron binding capacity (TIBC) for each participant were estimated throughout the study. Summary data of mean values of laboratory parameters are presented at Baseline and Week 36.
Mean Values of Albumin and Transferrin Concentration at Baseline and Week 36
The mean values of albumin and transferrin concentration for each participant throughout the study was estimated. Summary data of mean values of albumin and transferrin concentration at baseline and week 36 are presented.
Mean Values of Ferritin Concentration at Baseline and Week 36
Mean values of ferritin concentration for each participant throughout the study was estimated. Summary data of mean values of ferritin concentration at Baseline and Week 36 are presented.
Mean Values of Transferrin Saturation at Baseline and Week 36
The mean values of transferrin saturation (TS) for each participant were estimated throughout the study. Summary data of mean values of TS at Baseline and Week 36 are presented.
Mean Values of Aspartate Transaminase and Alkaline Phosphatase at Baseline and Week 36
The mean values of aspartate transaminase (AST) and alkaline phosphatase (ALP) levels in serum for each participant were estimated throughout the study. Summary data of mean values of Potassium and alkaline phosphatase level in serum at Baseline and Week 36 are presented.
Number of Participants With Adverse Events and Serious Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.
Number of Participants With Abnormal Changes in ECG From Baseline to Week 40
Twelve-lead ECG was performed.
Number of Participants With Abnormal Changes in Vital Signs From Baseline to Week 40
Vital signs included blood pressure, pulse rate and body weight.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00560404
Brief Title
A Study of Subcutaneous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
Official Title
A Randomized, Open Label Study to Compare the Effect of Once Monthly Administration of Subcutaneous Mircera Versus Epoetin Alfa on Maintenance of Hemoglobin Levels, Safety and Tolerability in Dialysis Patients With Chronic Renal Anemia.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This 2 arm study will compare the efficacy and safety of monthly administration of subcutaneous Mircera versus epoetin alfa for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will be randomized to receive either monthly injections of Mircera with a starting dose (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. 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 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
233 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention Description
120, 200 or 360 micrograms sc monthly (starting dose)
Intervention Type
Drug
Intervention Name(s)
Epoetin alfa
Intervention Description
As prescribed
Primary Outcome Measure Information:
Title
Percentage of Participants Maintaining Their Mean Hemoglobin Concentration Within Plus or Minus 1 Gram/Deciliter of Their Reference Hemoglobin and Between the Target Range During Efficacy Evaluation Period
Description
The target hemoglobin (Hb) range was defined as Hb concentration (gram/deciliter [g/dL]) between 10.5 and 12.5 g/dL during the efficacy evaluation period (EEP). EEP was from Week 29 to Week 36.
Time Frame
EEP (Week 29 to Week 36)
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Hemoglobin Concentration Between Baseline and at the Efficacy Evaluation Period
Description
The Baseline (Safety Verification Period) was from Week - 4 to Week -1.
Time Frame
Baseline (Weeks -4 to 0) and at EEP (Weeks 29 to 36)
Title
Percentage of Participants Maintaining Individual Hemoglobin Concentration Within the Range of 10.5 - 12.5 Gram/Decilitre Throughout the Efficacy Evaluation Period
Description
Percentage of participants maintaining individual Hb concentration within the Hb range 10.5 - 12.5 g/dL were reported during EEP. The EEP was from Week 29 to Week 36 of the study period.
Time Frame
EEP (Weeks 29 to 36)
Title
Mean Time Spent in Hemoglobin Range of 10.5 - 12.5 Gram/Decilitre During the Efficacy Evaluation Period
Description
Mean time to maintain Hb in the range of 10.5-12.5 g/dL during EEP is presented.
Time Frame
EEP (Week 29 to Week 36)
Title
Number of Participants Who Required Dose Adjustments During the Dose Titration Period
Description
The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28.
Time Frame
DTP (Weeks 0 to 28)
Title
Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period
Description
The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Efficacy Evaluation Period (EEP). The EEP was from Week 29 to Week 36.
Time Frame
EEP (Weeks 29 to 36)
Title
Number of Participants Received Red Blood Cells Transfusions
Description
The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported. For this study, blood transfusion was reported during the titration period. No transfusion occurred in the EEP.
Time Frame
Up to Week 28
Title
Mean Values of Hemoglobin Concentration at Baseline and Week 36
Description
The mean Hb concentration for each participant throughout the study was estimated. Summary data of mean values of Hb concentration at Baseline and Week 36 are presented.
Time Frame
Baseline and Week 36
Title
Mean Values of Hematocrit at Baseline and Week 36
Description
Hematocrit is the volume percentage of red blood cells in blood. The mean hematocrit for each participant was estimated throughout the study. Summary data of mean values of Hb at Baseline and Week 36 are presented.
Time Frame
Baseline and Week 36
Title
Mean Values of Mean Corpuscular Volume at Baseline and Week 36
Description
Mean corpuscular volume (MCV) is the average volume of red cells. The mean MCV concentration for each participant throughout the study was estimated. Summary data of mean values of MCV concentration at Baseline and Week 36 are presented.
Time Frame
Baseline and Week 36
Title
Mean Values of Leukocytes and Platelets Count at Baseline and Week 36
Description
The mean values of laboratory parameters: leukocytes and platelets count for each participant was estimated throughout the study. Summary data of mean values of leukocytes and platelets count at Baseline and Week 36 are presented.
Time Frame
Baseline and Week 36
Title
Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36
Description
Mean values of laboratory parameters: creatinine, potassium, phosphate, parathyroid hormone (PTH), iron and total iron binding capacity (TIBC) for each participant were estimated throughout the study. Summary data of mean values of laboratory parameters are presented at Baseline and Week 36.
Time Frame
Baseline and Week 36
Title
Mean Values of Albumin and Transferrin Concentration at Baseline and Week 36
Description
The mean values of albumin and transferrin concentration for each participant throughout the study was estimated. Summary data of mean values of albumin and transferrin concentration at baseline and week 36 are presented.
Time Frame
Baseline and Week 36
Title
Mean Values of Ferritin Concentration at Baseline and Week 36
Description
Mean values of ferritin concentration for each participant throughout the study was estimated. Summary data of mean values of ferritin concentration at Baseline and Week 36 are presented.
Time Frame
Baseline and Week 36
Title
Mean Values of Transferrin Saturation at Baseline and Week 36
Description
The mean values of transferrin saturation (TS) for each participant were estimated throughout the study. Summary data of mean values of TS at Baseline and Week 36 are presented.
Time Frame
Baseline and Week 36
Title
Mean Values of Aspartate Transaminase and Alkaline Phosphatase at Baseline and Week 36
Description
The mean values of aspartate transaminase (AST) and alkaline phosphatase (ALP) levels in serum for each participant were estimated throughout the study. Summary data of mean values of Potassium and alkaline phosphatase level in serum at Baseline and Week 36 are presented.
Time Frame
Baseline and Week 36
Title
Number of Participants With Adverse Events and Serious Adverse Events
Description
An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.
Time Frame
Up to Week 40
Title
Number of Participants With Abnormal Changes in ECG From Baseline to Week 40
Description
Twelve-lead ECG was performed.
Time Frame
From Baseline to Week 40
Title
Number of Participants With Abnormal Changes in Vital Signs From Baseline to Week 40
Description
Vital signs included blood pressure, pulse rate and body weight.
Time Frame
From Baseline to Week 40
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, >=18 years of age;
chronic renal anemia;
regular hemodialysis with the same schedule of dialysis for >=12 weeks;
maintenance therapy with subcutaneous epoetin alfa at the same administration interval for 4 weeks.
Exclusion Criteria:
transfusion of red blood cells during previous 2 months;
poorly controlled hypertension requiring interruption of epoetin alfa in previous 6 months;
acute or chronic bleeding;
active malignant disease (except non-melanoma skin cancer).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Belo Horizonte
ZIP/Postal Code
30150-320
Country
Brazil
City
Brasilia
ZIP/Postal Code
70390-108
Country
Brazil
City
Campinas
ZIP/Postal Code
13086-970
Country
Brazil
City
Campo Grande
ZIP/Postal Code
79002-073
Country
Brazil
City
Cariacica
ZIP/Postal Code
29152-230
Country
Brazil
City
Curitiba
ZIP/Postal Code
80050-350
Country
Brazil
City
Curitiba
ZIP/Postal Code
80440-020
Country
Brazil
City
Fortaleza
ZIP/Postal Code
60430160
Country
Brazil
City
Jaboatão Dos Guararapes
ZIP/Postal Code
54400-170
Country
Brazil
City
Joinville
ZIP/Postal Code
89227-680
Country
Brazil
City
Juiz de Fora
ZIP/Postal Code
36036900
Country
Brazil
City
Londrina
ZIP/Postal Code
86015-000
Country
Brazil
City
Natal
ZIP/Postal Code
59020-110
Country
Brazil
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
City
Porto Alegre
ZIP/Postal Code
90610000
Country
Brazil
City
Ribeirão Preto
ZIP/Postal Code
14025-170
Country
Brazil
City
Rio de Janeiro
Country
Brazil
City
Salvador
ZIP/Postal Code
40110-060
Country
Brazil
City
Sao Jose Do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
City
Sao Luis
ZIP/Postal Code
65020-305
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
01246-903
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
01323-900
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
01532-001
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
03065-000
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
O4023
Country
Brazil
City
Sorocaba
ZIP/Postal Code
18030-210
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
26965694
Citation
Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.
Results Reference
derived
Learn more about this trial
A Study of Subcutaneous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
We'll reach out to this number within 24 hrs