Back to resultsA Study for Monthly Methoxy Polyethylene Glycol-Epoetin Beta Treatment in Patients With Chronic Renal Anaemia
Primary Purpose
Anemia
Status
Terminated
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
methoxy polyethylene glycol-epoetin beta [Mircera]
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
Inclusion Criteria:
- Adults >/=18 years of age
- Chronic renal anaemia
- Haemoglobin concentration between 10 and 12 g/dL at screening
- Adequate iron status
- Continuous intravenous maintenance short-acting therapy with same dosing interval for 8 weeks prior to screening
- Regular long-term haemodialysis therapy for at least 12 weeks prior to screening
Exclusion Criteria:
- Change in haemoglobin concentration >/=2 g/dL during screening
- Transfusion of red blood cells less than 8 weeks prior to screening
- Poorly controlled hypertension
- Relevant acute or chronic bleeding requiring treatment less than 8 weeks prior to screening
- Active malignant disease
- Haemolysis
- Haemoglobinopathies
Sites / Locations
- Advent Hospital; Kidney and Hipertension
- Sanglah Hospital; Kidney and Hipertension
- Rumah Sakit Pgi Cikini; Renal & Hypertension
- Cipto Mangunkusumo Hospital; Renal and Hypertension division, Internal Medecine Department
- Pelni Hospital; Kidney and Hipertension
- Pondok Indah Hospital; Kidney and Hipertension
- Pantai Indah Kapuk Hospital; Kidney and Hipertension
- Klinik Spesialis Ginjal dan hipertensi Rasyida; Renal and Hypertension
- Pirngadi; Renal and Hypertension
- Telogorejo Hospital; Renal and Hypertension
- Dokter Soetomo Hospital
- PHC Hospital; Renal and Hypertension
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mircera
Arm Description
Outcomes
Primary Outcome Measures
Proportion of Participants Maintaining Average Haemoglobin During the Efficacy Evaluation Period Within the Target Range (10-12 g/dl)
The proportion of participants with their mean haemoglobin (Hb) concentration (g/dL) within the target range during the efficacy evaluation period was assessed. The target range is the reference Hb not >12 g/dL and not < 10 g/dL.
Secondary Outcome Measures
Number of Participants With Adverse Events and Serious Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. 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. The AEs were assessed from baseline to every visit throughout the treatment, post study drug discontinuation, and follow up period.
Mean Change in Haemoglobin Concentration From Screening Period and Efficacy Evaluation Period
The mean haemoglobin (Hb) concentration (g/dL) change from the baseline (Week 0) till efficacy evaluation period (EEP) was assessed and reported.
Proportion of Participants Maintaining Haemoglobin Concentration Within the Haemoglobin Range 10-12g/dL Throughout the Efficacy Evaluation Period
The proportion of participants maintaining haemoglobin concentration within the haemoglobin range 10-12g/dL throughout the efficacy evaluation period (EEP) was assessed and reported.
Mean Time Spent by Participants in the Haemoglobin Range of 10 - 12 g/dL During the Efficacy Evaluation Period
Mean time spent in the haemoglobin range 10 - 12 g/dL during the efficacy evaluation period (EEP) was assessed and reported.
Mean Number of Months Per Participant Requiring Dose Adjustment During the Dose Titration and Evaluation Periods
Mean number of months per participant requiring dose adjustment during the dose titration and evaluation periods was assessed and reported.
Mean Monthly Dose of Methoxy Polyethylene Glycol-epoetin Beta During the Dose Titration and Evaluation Periods
Mean monthly dose of methoxy polyethylene glycol-epoetin beta during the dose titration and evaluation periods was assessed and reported.
Number of Participants With Marked Laboratory Abnormalities
A marked laboratory abnormality is defined as above and/or below the normal range of a laboratory parameter which was considered to be potentially clinically relevant. The number of participants with marked laboratory abnormality are presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: Haemoglobin (Hb) (11.7-17.3 g/dL), Haematocrit (Hct) (35-47%), White blood cells (WBC) (3.6-11.0 10^3/µL), Red blood cells (RBC) (3.8- 5.9 10^6/µL), MCV (80-100 fL) Platelets (150-440 10^3/µL), Iron (37-158 µg/dL), Ferritin (10-365 ng/mL), Transferrin (170-340 mg/dL), TIBC (250-450 µg/dL), TSAT (15-50%), Albumin (3.4-4.8 g/dL), hs-CRP (<= 10.000 mg/dL), Potassium (3.5-5.1 mmol/L), and Phosphorus (2.7-4.5 mg/dL).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01066000
Brief Title
A Study for Monthly Methoxy Polyethylene Glycol-Epoetin Beta Treatment in Patients With Chronic Renal Anaemia
Official Title
A Single Arm Open Label Interventional Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous Methoxy-polyethylene Glycol-epoetin Beta 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
Terminated
Study Start Date
October 31, 2009 (Actual)
Primary Completion Date
September 30, 2011 (Actual)
Study Completion Date
September 30, 2011 (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 open-label single-arm study will evaluate the efficacy, safety and tolerability of methoxy polyethylene glycol epoetin beta on long-term maintenance of haemoglobin levels in patients with chronic renal anaemia. Patients will receive methoxy polyethylene glycol-epoetin beta intravenously once monthly at initial doses of either 120 micrograms or 200 micrograms or 360 micrograms in the titration phase of 16 weeks with a potential dose adjustment in the evaluation phase of 8 weeks. The anticipated time on study treatment is 24 weeks. The target sample size is 50-100 patients.
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
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mircera
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention Description
initial doses of either 120 micrograms or 200 micrograms or 360 micrograms, once monthly
Primary Outcome Measure Information:
Title
Proportion of Participants Maintaining Average Haemoglobin During the Efficacy Evaluation Period Within the Target Range (10-12 g/dl)
Description
The proportion of participants with their mean haemoglobin (Hb) concentration (g/dL) within the target range during the efficacy evaluation period was assessed. The target range is the reference Hb not >12 g/dL and not < 10 g/dL.
Time Frame
Up to Week 24
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events and Serious Adverse Events
Description
An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. 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. The AEs were assessed from baseline to every visit throughout the treatment, post study drug discontinuation, and follow up period.
Time Frame
Up to Week 28
Title
Mean Change in Haemoglobin Concentration From Screening Period and Efficacy Evaluation Period
Description
The mean haemoglobin (Hb) concentration (g/dL) change from the baseline (Week 0) till efficacy evaluation period (EEP) was assessed and reported.
Time Frame
Up to Week 24
Title
Proportion of Participants Maintaining Haemoglobin Concentration Within the Haemoglobin Range 10-12g/dL Throughout the Efficacy Evaluation Period
Description
The proportion of participants maintaining haemoglobin concentration within the haemoglobin range 10-12g/dL throughout the efficacy evaluation period (EEP) was assessed and reported.
Time Frame
Up to Week 24
Title
Mean Time Spent by Participants in the Haemoglobin Range of 10 - 12 g/dL During the Efficacy Evaluation Period
Description
Mean time spent in the haemoglobin range 10 - 12 g/dL during the efficacy evaluation period (EEP) was assessed and reported.
Time Frame
Up to Week 24
Title
Mean Number of Months Per Participant Requiring Dose Adjustment During the Dose Titration and Evaluation Periods
Description
Mean number of months per participant requiring dose adjustment during the dose titration and evaluation periods was assessed and reported.
Time Frame
Up to Week 24
Title
Mean Monthly Dose of Methoxy Polyethylene Glycol-epoetin Beta During the Dose Titration and Evaluation Periods
Description
Mean monthly dose of methoxy polyethylene glycol-epoetin beta during the dose titration and evaluation periods was assessed and reported.
Time Frame
Baseline, Week 4, Week 8, Week 12, Week 16, and Week 20
Title
Number of Participants With Marked Laboratory Abnormalities
Description
A marked laboratory abnormality is defined as above and/or below the normal range of a laboratory parameter which was considered to be potentially clinically relevant. The number of participants with marked laboratory abnormality are presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: Haemoglobin (Hb) (11.7-17.3 g/dL), Haematocrit (Hct) (35-47%), White blood cells (WBC) (3.6-11.0 10^3/µL), Red blood cells (RBC) (3.8- 5.9 10^6/µL), MCV (80-100 fL) Platelets (150-440 10^3/µL), Iron (37-158 µg/dL), Ferritin (10-365 ng/mL), Transferrin (170-340 mg/dL), TIBC (250-450 µg/dL), TSAT (15-50%), Albumin (3.4-4.8 g/dL), hs-CRP (<= 10.000 mg/dL), Potassium (3.5-5.1 mmol/L), and Phosphorus (2.7-4.5 mg/dL).
Time Frame
Up to Week 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults >/=18 years of age
Chronic renal anaemia
Haemoglobin concentration between 10 and 12 g/dL at screening
Adequate iron status
Continuous intravenous maintenance short-acting therapy with same dosing interval for 8 weeks prior to screening
Regular long-term haemodialysis therapy for at least 12 weeks prior to screening
Exclusion Criteria:
Change in haemoglobin concentration >/=2 g/dL during screening
Transfusion of red blood cells less than 8 weeks prior to screening
Poorly controlled hypertension
Relevant acute or chronic bleeding requiring treatment less than 8 weeks prior to screening
Active malignant disease
Haemolysis
Haemoglobinopathies
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
Advent Hospital; Kidney and Hipertension
City
Bandung
ZIP/Postal Code
40131
Country
Indonesia
Facility Name
Sanglah Hospital; Kidney and Hipertension
City
Denpasar
ZIP/Postal Code
80114
Country
Indonesia
Facility Name
Rumah Sakit Pgi Cikini; Renal & Hypertension
City
Jakarta
ZIP/Postal Code
10330
Country
Indonesia
Facility Name
Cipto Mangunkusumo Hospital; Renal and Hypertension division, Internal Medecine Department
City
Jakarta
ZIP/Postal Code
10440
Country
Indonesia
Facility Name
Pelni Hospital; Kidney and Hipertension
City
Jakarta
ZIP/Postal Code
11410
Country
Indonesia
Facility Name
Pondok Indah Hospital; Kidney and Hipertension
City
Jakarta
ZIP/Postal Code
12310
Country
Indonesia
Facility Name
Pantai Indah Kapuk Hospital; Kidney and Hipertension
City
Jakarta
ZIP/Postal Code
14460
Country
Indonesia
Facility Name
Klinik Spesialis Ginjal dan hipertensi Rasyida; Renal and Hypertension
City
Medan
ZIP/Postal Code
20119
Country
Indonesia
Facility Name
Pirngadi; Renal and Hypertension
City
Medan
ZIP/Postal Code
20234
Country
Indonesia
Facility Name
Telogorejo Hospital; Renal and Hypertension
City
Semarang
ZIP/Postal Code
50136
Country
Indonesia
Facility Name
Dokter Soetomo Hospital
City
Surabaya
ZIP/Postal Code
60286
Country
Indonesia
Facility Name
PHC Hospital; Renal and Hypertension
City
Surabaya
ZIP/Postal Code
60286
Country
Indonesia
12. IPD Sharing Statement
Learn more about this trial
A Study for Monthly Methoxy Polyethylene Glycol-Epoetin Beta Treatment in Patients With Chronic Renal Anaemia
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