A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA.

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

• Registration Number: NCT00661388
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This single arm study will assess the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with erythropoietin stimulating agents (ESA). Eligible patients will receive monthly subcutaneous injections of Mircera at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2008-04-16
• Study First Submitted QC: 2008-04-17
• Study First Posted: 2008-04-18
• Study Start: 2008-08
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2016-06-09
• Results First Submitted QC: 2016-06-09
• Status Verified: 2016-07
• Results First Posted: 2016-07-22
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• adult patients, >=18 years of age;
• chronic renal anemia;
• predialysis stage;
• no ESA therapy during previous 3 months.

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Exclusion Criteria

• transfusion of red blood cells during previous 2 months;
• poorly controlled hypertension requiring hospitalization in previous 6 months;
• significant acute or chronic bleeding.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Continuous erythropoietin receptor activator (C.E.R.A.)	methoxy polyethylene glycol-epoetin beta [Mircera]	Eligible participants will be administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. will be 1.2 micrograms/kilogram. Subsequent doses will be adjusted to maintain the individual participant's hemoglobin within the target range of 10.0 and 12.0 grams/deciliter.

Primary Outcome Measures

Name	Time	Method
Mean Change in Hb Concentration Between Baseline and the Efficacy Evaluation Period	From Baseline (Week 0) to EEP (Week 29 to Week 36)	Mean change in Hb concentration was calculated as the difference between the time adjusted average of Hb during the efficacy evaluation period (EEP \[Week 29 to Week 36\]), and the Hb at Baseline (Week 0). A positive change from baseline indicates improvement.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Received Red Blood Cell Transfusions During the Study Period	Up to Week 52	Red blood cell transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP (Week 0 to Week 28), EEP (Week 29 to Week 36), and during the long term safety period (LSTP \[Week 37 to Week 52\]) are presented.
Mean Time to Achievement of Response During the EEP	From Week 29 to Week 36	Participants with Hb concentrations within target range of 10-12 g/dl were considered to be responders. Mean time to achievement of response during the EEP (Week 29 to Week 36) is presented.
The Percentage of Participants Whose Hb Concentrations Remained Within the Target Range of 10.0- 12.0 g/dLThroughout the EEP	From Week 29 to Week 36	The percentage of participants whose Hb Concentrations remained within the target range of 10.0- 12.0 g/dL throughout the EEP (Week 29 to Week 36) is presented.
Mean Time Spent by Participants in the Target Range of 10.0- 12.0 g/dL During the EEP	From Week 29 to Week 36	Mean time spent by participants in the target range of 10.0- 12.0 g/dL during the EEP (Week 29 to Week 36) is presented.
Mean Change From Baseline in Hematocrit Level Over Time	Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48	Mean change from Baseline in hematocrit level was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Over Time	Baseline (Week 0), Weeks 8, 16, 24, 32, and 48	Mean change from Baseline in erythrocyte mean corpuscular volume was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP	Weeks 0 to Week 36	Percentage of participants requiring dose adjustments during dose titration period (DTP \[Week 0 to Week 28\]) and EEP (Week 29 to Week 36) is presented. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either ≥ 13 g/dL or \< 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10 to 12 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10.5 to 11.5 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.
Mean Change From Baseline in C-Reactive Protein Concentration Over Time	Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48	Mean change from Baseline in C-Reactive Protein concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events	Up to Week 52	An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant 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.
Mean Change From Baseline in Hb Concentration Over Time	Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48	Mean change from Baseline in Hb concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time	Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48	Mean change from Baseline in white blood cells (WBCs) and platelets concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
Mean Change From Baseline in Albumin Concentration Over Time	Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48	Mean change from Baseline in albumin concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time	Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48	Mean change from Baseline in phosphate and potassium concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time	Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48	Mean change from Baseline in total iron binding capacity (TIBC) and iron concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
Mean Change From Baseline in Creatinine Concentration Over Time	Baseline (Week 0), Weeks 8, 16, 32, 40	Mean change from Baseline in creatinine concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
Mean Change From Baseline in Ferritin Concentration Over Time	Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48	Mean change from Baseline in ferritin concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
Mean Change From Baseline in Transferrin Saturation Over Time	Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48	Mean change from Baseline in transferrin saturation (TSAT) was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.