Back to resultsA Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients.
Primary Purpose
Anemia
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Epoetin alfa
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, >=18 years of age;
- chronic kidney disease stage V;
- on peritoneal dialysis for 3 months prior to screening;
- on epoetin alfa sc >=3 months prior to screening.
Exclusion Criteria:
- patients expecting to change dialysis modality over course of study;
- patients hospitalized during previous 3 months for any clinically significant condition;
- active malignancy;
- bleeding episode necessitating transfusion, or overt gastrointestinal bleeding within 3 months prior to screening;
- transfusion of red blood cells within 3 months prior to screening.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RO0503821
Epoetin Alfa
Arm Description
Eligible participants will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) will be based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses will be adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization will continue to do so.
Eligible participants will be administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and will be followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization will continue to do so.
Outcomes
Primary Outcome Measures
Mean Change From Baseline in Hb Concentration to Average Over the Evaluation Period
Mean change in Hb concentration from Baseline (Day [D] 0) to average during the evaluation period (Month 7 to 9) is reported.
Secondary Outcome Measures
Percentage of Participants With Safety-Related Hb Measures
Safety-related Hb measures included percentage of participants with Hb value > 13 g/dL, 13.5 g/dL, increase in Hb value from baseline by > 2 g/dL or decrease in Hb value from baseline by > 2 g/dL at any time during the study.
Number of Participants With Marked Laboratory Abnormalities
Participants with marked laboratory abnormalities in hematology and clinical chemistry parameters are reported. Hematology laboratory parameters included hematocrit fraction, hemoglobin, platelets, white blood cells (WBCs) and clinical chemistry parameters included aspartate aminotransferase ([AST], alanine aminotransferase ([ALT], creatine phosphokinase (CPK), alkaline phosphatase, albumin, potassium, fasting glucose and phosphate.
Mean Change From Baseline in Iron
Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in iron to D1 of Months 2, 3, 4, 5, 6, 7, 8 is reported.
Mean Change From Baseline in Ferritin
Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in ferritin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.
Mean Change From Baseline in Transferrin Saturation
Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.
Mean Change From Baseline in Serum Transferrin
Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in serum transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.
Mean Change From Baseline in Total Iron-binding Capacity
Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in total Iron-binding Capacity to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.
Mean Change From Baseline in Temperature
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
Mean Change From Baseline in Pulse Rate
Mean Change From Baseline in Weight
Number of Participants With Anti-erythropoietin Antibody in Human Serum
Erythropoietin is human protein which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with erythropoietin, anti-erythropoietin antibody (Anti-EPO) may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond to treatment. Number of participants with anti-EPO antibody that are quantifiable and those that were "below the limit of quantification (BLQ)" at Baseline (Day 0) and Visit 17 (Month 9 [M 9]) or final visit/early termination in human serum samples are reported.
Number of Participants With Anti-RO0503821 Antibody in Human Serum
RO0503821 is a chemically modified erythropoietin which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with RO0503821, anti-RO0503821 antibody may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond. Number of participants with anti- RO0503821 antibody that are quantifiable and those that were "BLQ" at Baseline (Day 0) and Visit 17 (M 9) or final visit/early termination in human serum samples are reported.
Number of Participants With Any AEs, Any Serious Adverse Events and Death
An AE is untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalisation, life-threatening experience, persistent or significant disability/incapacity; congenital anomaly.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00442416
Brief Title
A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients.
Official Title
A Two-arm, Randomized, Open-label, Multicenter Study of Safety and Efficacy of Monthly Injections of RO0503821 Versus Epoetin Alfa in Peritoneal Dialysis Patients Who Self Inject or Receive In-center Injections.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
Strategic decision unrelated to safety or efficacy
Study Start Date
February 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (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 of monthly Mircera and epoetin alfa in peritoneal dialysis patients who self-inject at home or receive in-centre injections. The safety of subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be assessed. Eligible patients will be randomized either to receive monthly sc injections of Mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360 micrograms, or to remain on standard of care sc epoetin alfa. Dose adjustments will be permitted to reach/maintain a hemoglobin level of 10-12g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 380 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
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RO0503821
Arm Type
Experimental
Arm Description
Eligible participants will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) will be based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses will be adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization will continue to do so.
Arm Title
Epoetin Alfa
Arm Type
Active Comparator
Arm Description
Eligible participants will be administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and will be followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization will continue to do so.
Intervention Type
Drug
Intervention Name(s)
Epoetin alfa
Intervention Description
As prescribed, SC
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention Description
120-360 micrograms SC monthly, starting dose
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Hb Concentration to Average Over the Evaluation Period
Description
Mean change in Hb concentration from Baseline (Day [D] 0) to average during the evaluation period (Month 7 to 9) is reported.
Time Frame
From Baseline (D 0) to 9 months
Secondary Outcome Measure Information:
Title
Percentage of Participants With Safety-Related Hb Measures
Description
Safety-related Hb measures included percentage of participants with Hb value > 13 g/dL, 13.5 g/dL, increase in Hb value from baseline by > 2 g/dL or decrease in Hb value from baseline by > 2 g/dL at any time during the study.
Time Frame
Up to Month 9
Title
Number of Participants With Marked Laboratory Abnormalities
Description
Participants with marked laboratory abnormalities in hematology and clinical chemistry parameters are reported. Hematology laboratory parameters included hematocrit fraction, hemoglobin, platelets, white blood cells (WBCs) and clinical chemistry parameters included aspartate aminotransferase ([AST], alanine aminotransferase ([ALT], creatine phosphokinase (CPK), alkaline phosphatase, albumin, potassium, fasting glucose and phosphate.
Time Frame
Up to Month 9
Title
Mean Change From Baseline in Iron
Description
Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in iron to D1 of Months 2, 3, 4, 5, 6, 7, 8 is reported.
Time Frame
From Baseline (D 0) to Month (M) 2, M3, M4, M5, M6, M7, M8
Title
Mean Change From Baseline in Ferritin
Description
Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in ferritin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.
Time Frame
From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8
Title
Mean Change From Baseline in Transferrin Saturation
Description
Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.
Time Frame
From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8
Title
Mean Change From Baseline in Serum Transferrin
Description
Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in serum transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.
Time Frame
From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8
Title
Mean Change From Baseline in Total Iron-binding Capacity
Description
Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in total Iron-binding Capacity to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.
Time Frame
From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8
Title
Mean Change From Baseline in Temperature
Time Frame
From Baseline (D 0) to D1 and D15 of M7, M8
Title
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
Time Frame
From Baseline (D 0) to D1 and D15 of M7, M8
Title
Mean Change From Baseline in Pulse Rate
Time Frame
From Baseline (D 0) to D1 and D15 of M7, M8
Title
Mean Change From Baseline in Weight
Time Frame
From Baseline (D 0) to D1 and D15 of M7, M8
Title
Number of Participants With Anti-erythropoietin Antibody in Human Serum
Description
Erythropoietin is human protein which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with erythropoietin, anti-erythropoietin antibody (Anti-EPO) may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond to treatment. Number of participants with anti-EPO antibody that are quantifiable and those that were "below the limit of quantification (BLQ)" at Baseline (Day 0) and Visit 17 (Month 9 [M 9]) or final visit/early termination in human serum samples are reported.
Time Frame
Up to Month 9
Title
Number of Participants With Anti-RO0503821 Antibody in Human Serum
Description
RO0503821 is a chemically modified erythropoietin which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with RO0503821, anti-RO0503821 antibody may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond. Number of participants with anti- RO0503821 antibody that are quantifiable and those that were "BLQ" at Baseline (Day 0) and Visit 17 (M 9) or final visit/early termination in human serum samples are reported.
Time Frame
Up to Month 9
Title
Number of Participants With Any AEs, Any Serious Adverse Events and Death
Description
An AE is untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalisation, life-threatening experience, persistent or significant disability/incapacity; congenital anomaly.
Time Frame
Up to 9 months
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 kidney disease stage V;
on peritoneal dialysis for 3 months prior to screening;
on epoetin alfa sc >=3 months prior to screening.
Exclusion Criteria:
patients expecting to change dialysis modality over course of study;
patients hospitalized during previous 3 months for any clinically significant condition;
active malignancy;
bleeding episode necessitating transfusion, or overt gastrointestinal bleeding within 3 months prior to screening;
transfusion of red blood cells within 3 months prior to screening.
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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
City
Mountain View
State/Province
California
ZIP/Postal Code
94041
Country
United States
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80214
Country
United States
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13212
Country
United States
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74120
Country
United States
City
Lewistown
State/Province
Pennsylvania
ZIP/Postal Code
17044
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
City
Dyersburg
State/Province
Tennessee
ZIP/Postal Code
38024
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients.
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