A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.

Phase 4

Completed

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

• Registration Number: NCT00737711
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks with follow up 2 weeks after the last treatment visit. 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
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-08-18
• Study First Submitted QC: 2008-08-18
• Study First Posted: 2008-08-19
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Results First Submitted: 2016-03-08
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-26
• Last Update Submitted: 2016-04-26
• Results First Posted: 2016-06-02
• Last Update Posted: 2016-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

Inclusion Criteria

• male or female patients, >=18 years of age;
• chronic renal anemia (Hb concentration 8.0g/dL - 10.0g/dL);
• no prior erythropoietin stimulating agent (ESA) therapy.

Read More

Exclusion Criteria

• blood transfusion within the previous 4 weeks;
• poorly controlled hypertension;
• significant acute or chronic bleeding;
• active malignant disease;
• congestive heart failure (NYHA Class IV).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mircera	methoxy polyethylene glycol-epoetin beta [Mircera]	-

Primary Outcome Measures

Name	Time	Method
Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period	Baseline (Week 0) and Week 16	The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16.

Secondary Outcome Measures

Name	Time	Method
Mean Serum Albumin Over Time	Baseline (Week 0), Week 4, Week 10, and Week 16	Mean values of serum albumin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Mean Serum Globulin Over Time	Baseline (Week 0), Week 4, Week 10, and Week 16	Mean values of serum globulin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Mean Serum Creatinine Over Time	Baseline (Week 0), Week 4, Week 10, and Week 16	Mean values of serum creatinine are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Mean Blood Urea Nitrogen Over Time	Baseline (Week 0), Week 4, Week 10, and Week 16	Mean values of blood urea nitrogen (BUN) are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Mean Serum Potassium Over Time	Baseline (Week 0), Week 4, Week 10, and Week 16	Mean values of serum potassium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Mean Serum Sodium Over Time	Baseline (Week 0), Week 4, Week 10, and Week 16	Mean values of serum sodium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter	Up to Week 16	Achievement of blood Hb levels within target range of 10.0-12.0 g/dL was considered as achievement of response. The mean time required to achieve the Hb target range is presented in weeks.
Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16	Week 12 to Week 16	The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The mean time spent (in weeks) by the participants in the target range (10-12 g/dL) during the last 4 weeks of the TP is presented.
Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16	Week 12 to Week 16	The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The percentage of participants achieving Hb levels within target range of 10.0-12.0 g/dL during the last 4 weeks of the TP is presented.
Number of Participants With Adverse Events, Serious Adverse Events and Deaths	Up to Week 18	An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. An SAE is any AE that can result in death or is life-threatening or required participant hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above
Number of Participants With Abnormal Electrocardiogram	Up to Week 16	Twelve-lead electrocardiogram (ECG) was recorded for the participants. The number of participants with abnormal ECG is presented.
Number of Participants With Reports of Blood Transfusions	Up to Week 16	Indications for blood transfusions were acute blood loss (bleeding), lack of treatment response or treatment failure, or other reasons.
Number of Participants With Reports of Anti-Epoetin Antibodies	Up to Week 16	Participants were assessed for the presence of Anti-Epoetin antibodies for MIRCERA.
Mean White Blood Cell Count Over Time	Baseline (Week 0), Week 4, Week 10, and Week 16	The mean values of white blood cells are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Mean Value of Mean Corpuscular Volume Over Time	Baseline (Week 0), Week 4, Week 10, and Week 16	Mean corpuscular volume (MCV) is a measure of the average volume of red blood corpuscles (RBCs) and is calculated by dividing hematocrit value by the concentration of RBCs. Mean values of MCV are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. Reference range of mean corpuscular volume is 80-96 femtoliter (fL) per red blood cell.
Mean Hypochromic Red Blood Cells Over Time	Baseline (Week 0), Week 4, Week 10, and Week 16	Mean values of hypochromic RBCs are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Mean Platelet Count Over Time	Baseline (Week 0), Week 4, Week 10, and Week 16	Mean values of platelet count are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Mean Serum Iron Over Time	Baseline (Week 0), Week 4, Week 10, and Week 16	Mean values of serum iron are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Mean Serum Ferritin Over Time	Baseline (Week 0), Week 4, Week 10, and Week 16	Mean values of serum ferritin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Mean Transferrin Over Time	Baseline (Week 0), Week 4, Week 10, and Week 16	Mean values of serum transferrin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Mean Total Iron-binding Capacity Over Time	Baseline (Week 0), Week 4, Week 10, and Week 16	Mean values of total iron-binding capacity are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Mean Transferrin Saturation Over Time	Baseline (Week 0), Week 4, Week 10, and Week 16	Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is calculated as serum iron/ total iron-binding capacity x 100. Mean values of transferrin saturation at Baseline (Week 0), Week 4, Week 10, and Week 16 are presented.
Mean Serum Phosphate Over Time	Baseline (Week 0), Week 4, Week 10, and Week 16	Mean values of serum phosphate are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Mean Serum Bilirubin Over Time	Baseline (Week 0), Week 4, Week 10, and Week 16	Mean values of serum bilirubin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Mean Aspartate Transaminase Over Time	Baseline (Week 0), Week 4, Week 10, and Week 16	Mean values of aspartate transaminase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Mean Alanine Aminotransferase Over Time	Baseline (Week 0), Week 4, Week 10, and Week 16	Mean values of alanine aminotransferase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Mean Serum Alkaline Phosphatase Over Time	Baseline (Week 0), Week 4, Week 10, and Week 16	Mean values of serum alkaline phosphatase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.