Back to resultsA Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia
Primary Purpose
Anemia
Status
Completed
Phase
Phase 4
Locations
Egypt
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:
- Adult patients, age >/=18 years
- Diagnosis of chronic renal anemia
- Not on dialysis
- Hemoglobin concentration <10 g/dl
- No erythropoiesis stimulating agent (ESA) therapy during the 3 months before study start
- Estimated glomerular filtration rate (EGFR) <60 ml/min and >/=20 ml/min
- Adequate iron status
Exclusion Criteria:
- Transfusion of red blood cells during the previous 2 months
- Poorly controlled hypertension
- Significant acute or chronic bleeding, e.g. gastrointestinal bleeding
- Active malignant disease (except non-melanoma skin cancer)
- Hemolysis
- Hemoglobinopathies, e.g. sickle-cell disease, thalassemia
Sites / Locations
- Alexandria University; Endocrinology Department
- El Qahira Al Fatemeya Hospital
- Kasr El Ainy University Hospital; Endocrinology Department
- Nasser Institute
- Mansoura Kidney Center; Nephrology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Mean Hb Concentration at Week 20
Per Protocol (PP) Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin less than or equal to [≤] 100 nanogram per milliliter [ng/mL] or mean transferrin saturation [TSAT] ≤20% or mean hypochromic red blood cells [RBCs] greater than or equal to [≥] 10% during efficacy evaluation period [Weeks 20 to 28]).
Change From Baseline in Mean Hb Concentration at Week 24
PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).
Change From Baseline in Mean Hb Concentration at Week 28
PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01342640
Brief Title
A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia
Official Title
A Single Arm, Open Label, Multicenter Phase IIIb/IV Clinical Trial to Assess the Efficacy, Safety and Tolerability of Monthly Administration of C.E.R.A. for the Treatment of Not on Dialysis Chronic Renal Anemia Not Currently Treated With ESA
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 18, 2011 (Actual)
Primary Completion Date
November 30, 2012 (Actual)
Study Completion Date
November 30, 2012 (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, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on dialysis. Patients will receive as a recommended starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is dependent on the patient's weight. Dose adjustment may be required due to inadequate or excessive treatment response. The anticipated time on study treatment is 28 weeks.
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
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention Description
Recommended starting dose 1.2 micrograms/kg subcutaneously every 4 weeks (depending on patient's weight). Dose adjustment may be required in the event of inadequate or excessive treatment response.
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Hb Concentration at Week 20
Description
Per Protocol (PP) Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin less than or equal to [≤] 100 nanogram per milliliter [ng/mL] or mean transferrin saturation [TSAT] ≤20% or mean hypochromic red blood cells [RBCs] greater than or equal to [≥] 10% during efficacy evaluation period [Weeks 20 to 28]).
Time Frame
Baseline (Week 0), Week 20
Title
Change From Baseline in Mean Hb Concentration at Week 24
Description
PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).
Time Frame
Baseline (Week 0), Week 24
Title
Change From Baseline in Mean Hb Concentration at Week 28
Description
PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).
Time Frame
Baseline (Week 0), Week 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, age >/=18 years
Diagnosis of chronic renal anemia
Not on dialysis
Hemoglobin concentration <10 g/dl
No erythropoiesis stimulating agent (ESA) therapy during the 3 months before study start
Estimated glomerular filtration rate (EGFR) <60 ml/min and >/=20 ml/min
Adequate iron status
Exclusion Criteria:
Transfusion of red blood cells during the previous 2 months
Poorly controlled hypertension
Significant acute or chronic bleeding, e.g. gastrointestinal bleeding
Active malignant disease (except non-melanoma skin cancer)
Hemolysis
Hemoglobinopathies, e.g. sickle-cell disease, thalassemia
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
Alexandria University; Endocrinology Department
City
Alexandria
Country
Egypt
Facility Name
El Qahira Al Fatemeya Hospital
City
Cairo
Country
Egypt
Facility Name
Kasr El Ainy University Hospital; Endocrinology Department
City
Cairo
Country
Egypt
Facility Name
Nasser Institute
City
Cairo
Country
Egypt
Facility Name
Mansoura Kidney Center; Nephrology
City
Mansoura
ZIP/Postal Code
0
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia
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