Back to resultsA Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
methoxy polyethylene glycol-epoetin beta
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;
- continuous stable iv or sc maintenance epoetin therapy during previous 4 weeks;
- regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.
Exclusion Criteria:
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring hospitalization or interruption of epoetin treatment in previous 6 months;
- significant acute or chronic bleeding.
Sites / Locations
- Cukurova University Medical Faculty; Internal Medicine
- Ankara Research and Training Hospital; The Clinic of Nephrology
- Ankara University School of Medicine; Nephrology
- Faith University School of Medicine; Nephrology
- Hacettepe University Medical Faculty; Department of Internal Medicine
- Baskent University Hospital; Transplantation
- Gazi University School of Medicine; Nephrology
- Adnan Menderes Uni School of Medicine; Physical Therapy & Rehabilitation
- Dicle Uni Medical Faculty; Internal Medicine
- Trakya University Medical Faculty; Internal Medicine; Nephrology
- Firat Uni School Of Medicine; Nephrology
- Ataturk University Medical Faculty; Department of Internal Medicine
- Sisli Etfal Research and Training Hospital; The Clinic of Nephrology
- Istanbul University Istanbul Medical Faculty; Department of Internal Medicine
- Marmara Uni School of Medicine; Nephrology
- Izmir Ataturk Research and Training Hospital; The Clinic of Nephrology
- Dokuz Eylul University School of Medicine; Nephrology
- Erciyes University School of Medicine; Nephrology
- Inonu Uni School of Medicine
- Mersin University Medical Faculty
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
C.E.R.A. 120, 200, or 360 mcg
Arm Description
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
Outcomes
Primary Outcome Measures
Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period
The reference hemoglobin (Hb) value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0). The time adjusted average Hb concentration of all the values recorded during the efficacy evaluation period (EEP) was calculated for each participant and their reference Hb concentration was subtracted from this value. The percentage of participants maintaining their average Hb concentration during the EEP within +/- 1 gram/deciliter (g/dL) of their reference Hb concentration and between the Hb range 10.0 -12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24. Data missing at the end of the EEP was handled using the last value carried forward method, including any data missing due to withdrawal of participants following red blood cells (RBC) transfusion.
Secondary Outcome Measures
Mean Change in Hemoglobin Concentration Between the Stability Verification Period and the Efficacy Evaluation Period
The mean change in the time-adjusted average Hb concentration between the two study periods The Stability Verification Period (SVP) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.
Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period
The time adjusted average Hb concentration of all the values recorded during the EEP was calculated for each participant. The percentage of participants maintaining their average Hb concentration during the EEP within the Hb concentration range of 10.0-12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24.
Median Time Spent in the Hemoglobin Range 10.0-12.0 Gram/Deciliter During the Efficacy Evaluation Period
The Hb concentration was recorded for all the participants during the EEP. The median time spent (in days) by participants in the target range (10.0-12.0 g/dL) during the EEP is presented. The EEP was defined as Week 16 to Week 24.
Mean C.E.R.A. Dose Required to Maintain Hemoglobin Level Within the Range 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period
The mean dose of C.E.R.A. required to maintain Hb level between 10.0-12.0 g/dL during the EEP was calculated per participant and then summarized. The EEP was defined as Week 16 to Week 24. However, C.E.R.A. was not administered at the Week 24 visit. Therefore, the time period for calculation of mean C.E.R.A. dose during EEP is from Week 16 to Week 20.
Percentage of Participants Requiring Any Dose Adjustments in C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period
Dose adjustments were necessary when Hb increased or decreased by a clinically significant amount. The dose of C.E.R.A. was adjusted to maintain the individual participant's Hb within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.0 and 12.0 g/dL throughout the dose titration period (DTP) and the EEP (Week 1 to Week 24). The reference Hb value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0).
Mean Monthly Dose of C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period
The mean monthly dose of C.E.R.A. administered during the DTP and EEP was calculated per participant and then summarized.
Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume at Week 16 and Week 24
Mean change from Baseline in erythrocyte mean corpuscular volume (MCV) was calculated as the value at a specific week during the study minus the BL value. The Baseline was defined as Week -4 to Week 0.
Mean Change From Baseline in Hematocrit at Week 16 and Week 24
The hematocrit, also called packed cell volume or erythrocyte volume fraction, is the volume percentage of red blood cells in the blood. Mean change from Baseline (BL) in hematocrit was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Mean Change From Baseline in Hemoglobin at Week 16 and Week 24
Mean change from BL in hemoglobin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Mean Change From Baseline in Leucocytes and Platelet at Week 16 and Week 24
Mean change from BL in for each parameter (leucocytes and platelet) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Mean Change From Baseline in Ferritin at Week 16 and Week 24
Mean change from BL in ferritin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Mean Change From Baseline in Iron, Total Iron Binding Capacity, and Creatinine at Week 16 and Week 24
Mean change from BL in each parameter [iron, total iron binding capacity (TIBC), and creatinine] was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Mean Change From Baseline in Transferrin and Albumin at Week 16 and Week 24
Mean change from BL in each parameter (transferrin and albumin) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Mean Change From Baseline in Transferrin Saturation at Week 16 and Week 24
Mean change from BL in transferrin saturation (TSAT) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Mean Change From Baseline in C-Reactive Protein at Week 16 and Week 24
Mean change from BL in C-reactive protein was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Mean Change From Baseline in Phosphate and Potassium at Week 16 and Week 24
Mean change from BL in each parameter (phosphate and potassium) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Mean Change From Baseline in Weight at Week 16 and Week 24
Mean change from BL in weight was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured before blood sampling and C.E.R.A. administration. Blood pressure was assessed both before and after the dialysis session for participants undergoing hemodialysis. Change from BL in blood pressure was calculated as the value at a specific week (W) during the study minus the BL value. The baseline was defined as Week -4 to Week 0.
Number of Participants Taking Concomitant Medications
The number of participants taking different classes of concomitant medications at any time following enrollment into the study is presented.
Number of Participants With Any Adverse Events and Serious Adverse Events
An adverse event (AE) is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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 Reports of Anti-erythropoietin Antibodies
The number of participants with Anti-epoetin antibodies is presented.
Number of Participants Who Received Red Blood Cell Transfusions During the Dose Titration Period and Efficacy Evaluation Period
Red blood cell transfusions were permitted during the DTP and EEP (Week 1 to Week 24) in case of medical need. All participants requiring a blood transfusion were withdrawn from the study. The number of participants who were administered RBC transfusions during the DTP and EEP is presented.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00661505
Brief Title
A Study of Intravenous Mircera in Hemodialysis 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 C.E.R.A. for the Maintenance of Haemoglobin Levels in Haemodialysis Patients With Chronic Renal Anaemia.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 14, 2008 (Actual)
Primary Completion Date
June 22, 2010 (Actual)
Study Completion Date
June 22, 2010 (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 assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. 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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
C.E.R.A. 120, 200, or 360 mcg
Arm Type
Experimental
Arm Description
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta
Intervention Description
120, 200 or 360 micrograms iv every 4 weeks (starting dose)
Primary Outcome Measure Information:
Title
Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period
Description
The reference hemoglobin (Hb) value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0). The time adjusted average Hb concentration of all the values recorded during the efficacy evaluation period (EEP) was calculated for each participant and their reference Hb concentration was subtracted from this value. The percentage of participants maintaining their average Hb concentration during the EEP within +/- 1 gram/deciliter (g/dL) of their reference Hb concentration and between the Hb range 10.0 -12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24. Data missing at the end of the EEP was handled using the last value carried forward method, including any data missing due to withdrawal of participants following red blood cells (RBC) transfusion.
Time Frame
EEP (Week 16 to Week 24)
Secondary Outcome Measure Information:
Title
Mean Change in Hemoglobin Concentration Between the Stability Verification Period and the Efficacy Evaluation Period
Description
The mean change in the time-adjusted average Hb concentration between the two study periods The Stability Verification Period (SVP) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.
Time Frame
SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)
Title
Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period
Description
The time adjusted average Hb concentration of all the values recorded during the EEP was calculated for each participant. The percentage of participants maintaining their average Hb concentration during the EEP within the Hb concentration range of 10.0-12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24.
Time Frame
EEP (Week 16 to Week 24)
Title
Median Time Spent in the Hemoglobin Range 10.0-12.0 Gram/Deciliter During the Efficacy Evaluation Period
Description
The Hb concentration was recorded for all the participants during the EEP. The median time spent (in days) by participants in the target range (10.0-12.0 g/dL) during the EEP is presented. The EEP was defined as Week 16 to Week 24.
Time Frame
EEP (Week 16 to Week 24)
Title
Mean C.E.R.A. Dose Required to Maintain Hemoglobin Level Within the Range 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period
Description
The mean dose of C.E.R.A. required to maintain Hb level between 10.0-12.0 g/dL during the EEP was calculated per participant and then summarized. The EEP was defined as Week 16 to Week 24. However, C.E.R.A. was not administered at the Week 24 visit. Therefore, the time period for calculation of mean C.E.R.A. dose during EEP is from Week 16 to Week 20.
Time Frame
EEP (Week 16 to Week 20)
Title
Percentage of Participants Requiring Any Dose Adjustments in C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period
Description
Dose adjustments were necessary when Hb increased or decreased by a clinically significant amount. The dose of C.E.R.A. was adjusted to maintain the individual participant's Hb within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.0 and 12.0 g/dL throughout the dose titration period (DTP) and the EEP (Week 1 to Week 24). The reference Hb value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0).
Time Frame
DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)
Title
Mean Monthly Dose of C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period
Description
The mean monthly dose of C.E.R.A. administered during the DTP and EEP was calculated per participant and then summarized.
Time Frame
DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)
Title
Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume at Week 16 and Week 24
Description
Mean change from Baseline in erythrocyte mean corpuscular volume (MCV) was calculated as the value at a specific week during the study minus the BL value. The Baseline was defined as Week -4 to Week 0.
Time Frame
BL (Week -4 to Week 0), Week 16, and Week 24
Title
Mean Change From Baseline in Hematocrit at Week 16 and Week 24
Description
The hematocrit, also called packed cell volume or erythrocyte volume fraction, is the volume percentage of red blood cells in the blood. Mean change from Baseline (BL) in hematocrit was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Time Frame
BL (Week -4 to Week 0), Week 16, and Week 24
Title
Mean Change From Baseline in Hemoglobin at Week 16 and Week 24
Description
Mean change from BL in hemoglobin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Time Frame
BL (Week -4 to Week 0), Week 16, and Week 24
Title
Mean Change From Baseline in Leucocytes and Platelet at Week 16 and Week 24
Description
Mean change from BL in for each parameter (leucocytes and platelet) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Time Frame
BL (Week -4 to Week 0), Week 16, and Week 24
Title
Mean Change From Baseline in Ferritin at Week 16 and Week 24
Description
Mean change from BL in ferritin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Time Frame
BL (Week -4 to Week 0), Week 16, and Week 24
Title
Mean Change From Baseline in Iron, Total Iron Binding Capacity, and Creatinine at Week 16 and Week 24
Description
Mean change from BL in each parameter [iron, total iron binding capacity (TIBC), and creatinine] was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Time Frame
BL (Week -4 to Week 0), Week 16, and Week 24
Title
Mean Change From Baseline in Transferrin and Albumin at Week 16 and Week 24
Description
Mean change from BL in each parameter (transferrin and albumin) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Time Frame
BL (Week -4 to Week 0), Week 16, and Week 24
Title
Mean Change From Baseline in Transferrin Saturation at Week 16 and Week 24
Description
Mean change from BL in transferrin saturation (TSAT) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Time Frame
BL (Week -4 to Week 0), Week 16, and Week 24
Title
Mean Change From Baseline in C-Reactive Protein at Week 16 and Week 24
Description
Mean change from BL in C-reactive protein was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Time Frame
BL (Week -4 to Week 0), Week 16, and Week 24
Title
Mean Change From Baseline in Phosphate and Potassium at Week 16 and Week 24
Description
Mean change from BL in each parameter (phosphate and potassium) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Time Frame
BL (Week -4 to Week 0), Week 16, and Week 24
Title
Mean Change From Baseline in Weight at Week 16 and Week 24
Description
Mean change from BL in weight was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Time Frame
BL (Week -4 to Week 0), Week 16, and Week 24
Title
Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24
Description
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured before blood sampling and C.E.R.A. administration. Blood pressure was assessed both before and after the dialysis session for participants undergoing hemodialysis. Change from BL in blood pressure was calculated as the value at a specific week (W) during the study minus the BL value. The baseline was defined as Week -4 to Week 0.
Time Frame
Baseline (Week -4 to Week 0), Week 16, and Week 24
Title
Number of Participants Taking Concomitant Medications
Description
The number of participants taking different classes of concomitant medications at any time following enrollment into the study is presented.
Time Frame
Up to Week 28
Title
Number of Participants With Any Adverse Events and Serious Adverse Events
Description
An adverse event (AE) is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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.
Time Frame
Up to Week 28
Title
Number of Participants With Reports of Anti-erythropoietin Antibodies
Description
The number of participants with Anti-epoetin antibodies is presented.
Time Frame
Up to Week 24
Title
Number of Participants Who Received Red Blood Cell Transfusions During the Dose Titration Period and Efficacy Evaluation Period
Description
Red blood cell transfusions were permitted during the DTP and EEP (Week 1 to Week 24) in case of medical need. All participants requiring a blood transfusion were withdrawn from the study. The number of participants who were administered RBC transfusions during the DTP and EEP is presented.
Time Frame
Week 1 to Week 24
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;
continuous stable iv or sc maintenance epoetin therapy during previous 4 weeks;
regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.
Exclusion Criteria:
transfusion of red blood cells during previous 2 months;
poorly controlled hypertension requiring hospitalization or interruption of epoetin treatment in previous 6 months;
significant acute or chronic bleeding.
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
Cukurova University Medical Faculty; Internal Medicine
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Ankara Research and Training Hospital; The Clinic of Nephrology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Ankara University School of Medicine; Nephrology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Faith University School of Medicine; Nephrology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Hacettepe University Medical Faculty; Department of Internal Medicine
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Baskent University Hospital; Transplantation
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Facility Name
Gazi University School of Medicine; Nephrology
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Adnan Menderes Uni School of Medicine; Physical Therapy & Rehabilitation
City
Aydin
ZIP/Postal Code
09100
Country
Turkey
Facility Name
Dicle Uni Medical Faculty; Internal Medicine
City
Diyarbakir
ZIP/Postal Code
10000
Country
Turkey
Facility Name
Trakya University Medical Faculty; Internal Medicine; Nephrology
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Firat Uni School Of Medicine; Nephrology
City
Elazig
ZIP/Postal Code
23110
Country
Turkey
Facility Name
Ataturk University Medical Faculty; Department of Internal Medicine
City
Erzurum
ZIP/Postal Code
25240
Country
Turkey
Facility Name
Sisli Etfal Research and Training Hospital; The Clinic of Nephrology
City
Istanbul
ZIP/Postal Code
34377
Country
Turkey
Facility Name
Istanbul University Istanbul Medical Faculty; Department of Internal Medicine
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Marmara Uni School of Medicine; Nephrology
City
Istanbul
ZIP/Postal Code
34662
Country
Turkey
Facility Name
Izmir Ataturk Research and Training Hospital; The Clinic of Nephrology
City
Izmir
ZIP/Postal Code
35290
Country
Turkey
Facility Name
Dokuz Eylul University School of Medicine; Nephrology
City
Izmir
Country
Turkey
Facility Name
Erciyes University School of Medicine; Nephrology
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
Inonu Uni School of Medicine
City
Malatya
ZIP/Postal Code
44300
Country
Turkey
Facility Name
Mersin University Medical Faculty
City
Mersin
ZIP/Postal Code
33169
Country
Turkey
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 Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia
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