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

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

India

Study Type

Interventional

Intervention

methoxy polyethylene glycol-epoetin beta [Mircera]

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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).

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mircera

Arm Description

Outcomes

Primary Outcome Measures

Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period

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

Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter

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

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

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

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

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

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

Participants were assessed for the presence of Anti-Epoetin antibodies for MIRCERA.

Mean White Blood Cell Count Over Time

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

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

Mean values of hypochromic RBCs are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

Mean Platelet Count Over Time

Mean values of platelet count are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

Mean Serum Iron Over Time

Mean values of serum iron are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

Mean Serum Ferritin Over Time

Mean values of serum ferritin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

Mean Transferrin Over Time

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

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

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 Albumin Over Time

Mean values of serum albumin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

Mean Serum Globulin Over Time

Mean values of serum globulin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

Mean Serum Creatinine Over Time

Mean values of serum creatinine are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

Mean Blood Urea Nitrogen Over Time

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

Mean values of serum potassium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

Mean Serum Sodium Over Time

Mean values of serum sodium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

Mean Serum Phosphate Over Time

Mean values of serum phosphate are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

Mean Serum Bilirubin Over Time

Mean values of serum bilirubin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

Mean Aspartate Transaminase Over Time

Mean values of aspartate transaminase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

Mean Alanine Aminotransferase Over Time

Mean values of alanine aminotransferase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

Mean Serum Alkaline Phosphatase Over Time

Mean values of serum alkaline phosphatase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

Full Information

NCT ID

NCT00737711

First Posted

August 18, 2008

Last Updated

April 26, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00737711

Brief Title

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

Official Title

A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Two Weekly Administration of Intravenous Methoxy Polyethylene Glycol-epoetin Beta (MIRCERA) for the Treatment of Chronic Renal Anemia in Dialysis Patients Not Currently Treated With Erythropoietin-stimulating Agent (ESA).

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (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 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.

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

189 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mircera

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

methoxy polyethylene glycol-epoetin beta [Mircera]

Intervention Description

iv 0.6 micrograms/kg every 2 weeks

Primary Outcome Measure Information:

Title

Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period

Description

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.

Time Frame

Baseline (Week 0) and Week 16

Secondary Outcome Measure Information:

Title

Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter

Description

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.

Time Frame

Up to Week 16

Title

Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16

Description

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.

Time Frame

Week 12 to Week 16

Title

Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16

Description

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.

Time Frame

Week 12 to Week 16

Title

Number of Participants With Adverse Events, Serious Adverse Events and Deaths

Description

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

Time Frame

Up to Week 18

Title

Number of Participants With Abnormal Electrocardiogram

Description

Twelve-lead electrocardiogram (ECG) was recorded for the participants. The number of participants with abnormal ECG is presented.

Time Frame

Up to Week 16

Title

Number of Participants With Reports of Blood Transfusions

Description

Indications for blood transfusions were acute blood loss (bleeding), lack of treatment response or treatment failure, or other reasons.

Time Frame

Up to Week 16

Title

Number of Participants With Reports of Anti-Epoetin Antibodies

Description

Participants were assessed for the presence of Anti-Epoetin antibodies for MIRCERA.

Time Frame

Up to Week 16

Title

Mean White Blood Cell Count Over Time

Description

The mean values of white blood cells are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

Time Frame