A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Morocco

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:

adult patients >=18 years of age;
chronic renal anemia;
regular long-term hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months;
continuous iv maintenance epoetin alfa therapy with same dosing interval during previous 2 months.

Exclusion Criteria:

transfusion of red blood cells during previous 2 months;
poorly controlled hypertension;
significant acute or chronic bleeding;
active malignant disease (except non-melanoma skin cancer).

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

C.E.R.A.

Arm Description

Eligible participants will be administered continuous erythropoietin receptor activator (C.E.R.A.[Mircera]) intravenously (IV) every 4 weeks for 44 weeks. The starting dose of 120, 200, or 360 micrograms (mcg) will be based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses will be adjusted to maintain the individual participant's hemoglobin (Hb) within a range of +/- 1.0 grams per deciliter (g/dL) of the reference hemoglobin (Hb) concentration and between 10.50 and 12.50 g/dL.

Outcomes

Primary Outcome Measures

Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period

The percentage of participants who maintained their mean Hb concentration within +/- 1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the Efficacy Evaluation Period (EEP) is reported. The EEP was from Week 17 to Week 24. The reference Hb was calculated from the mean of Hb concentrations based upon the Hb assessments at Weeks -4, -3, -2, -1, and 0.

Secondary Outcome Measures

Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period

Mean change in Hb concentration between reference SVP and the EEP is reported. The SVP was at Weeks -3, -2, -1, and EEP was from Week 17 to Week 24. Participants received epoetin alfa or beta during SVP.

Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP

Percentage of participants maintaining Hb concentration within the range of 10.5-12.5 g/dL throughout the EEP is reported. The EEP was from Week 17 to Week 24.

Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP

Mean time spent by participants in Hb range of 10.5-12.5 g/dL during the EEP is reported. The EEP was from Week 17 to Week 24.

Number of Participants With Any Adverse Events or Serious Adverse Events

An adverse event (AE) is untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAEs) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, and congenital anomaly.

Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP

Percentage of participants requiring any dose adjustment during DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24) is reported. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either > or = 13 g/dL or < or = 9 g/dL; if the difference of 2 consecutive Hb concentrations was > or =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 10.5 to 11.5 g/dL, the difference between the reference value (mean of Hb concentrations based on the Hb assessments at Weeks -4, -3, -2, -1, and 0) and the most recent value was >1 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 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.

Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase

Red Blood Cells (RBCs) transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP, EEP, and during the long term safety period (LTSP) were reported.

Mean Hemoglobin Levels Over Time

The Hb levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.

Mean Hematocrit Levels Over Time

The hematocrit (HCT) levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.

Mean Albumin Levels Over Time

The albumin levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.

Mean White Blood Cells and Thrombocytes Over Time

The white blood cells (WBCs) and thrombocyte levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.

Mean Phosphate and Potassium Levels Over Time

The phosphate and potassium levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.

Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time

The mean creatinine, iron, and total iron binding capacity (TIBC) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.

Mean C-Reactive Protein Levels Over Time

The mean C-Reactive Protein (CRP) Levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.

Mean Ferritin Levels Over Time

The mean ferritin levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.

Mean Transferrin Saturation Levels Over Time

The mean transferrin saturation (TSAT) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.

Mean Change From Baseline in Pulse Rate Over Time

Mean change in pulse rate was defined as the difference between mean pulse rate at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).

Mean Change From Baseline in Blood Pressure Over Time

Mean change in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) before and after dialysis was defined as the difference between mean blood pressure at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).

Mean Change From Baseline in Weight Over Time

Mean change in weight was defined as the difference between mean weight at Baseline and following visits (Week 16 and Week 48).

Full Information

NCT ID

NCT00882713

First Posted

February 17, 2009

Last Updated

August 12, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00882713

Brief Title

A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia

Official Title

A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once- Monthly Administration of Subcutaneous CERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anemia

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (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 assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting dose of 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. Treatment duration is 56 weeks, and the target sample size is 200 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

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

202 (Actual)

8. Arms, Groups, and Interventions

Arm Title

C.E.R.A.

Arm Type

Experimental

Arm Description

Eligible participants will be administered continuous erythropoietin receptor activator (C.E.R.A.[Mircera]) intravenously (IV) every 4 weeks for 44 weeks. The starting dose of 120, 200, or 360 micrograms (mcg) will be based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses will be adjusted to maintain the individual participant's hemoglobin (Hb) within a range of +/- 1.0 grams per deciliter (g/dL) of the reference hemoglobin (Hb) concentration and between 10.50 and 12.50 g/dL.

Intervention Type

Drug

Intervention Name(s)

methoxy polyethylene glycol-epoetin beta [Mircera]

Other Intervention Name(s)

C.E.R.A.

Intervention Description

Subcutaneous injection every 4 weeks (starting dose of 120, 200 or 360 micrograms, based on previous ESA therapy)

Primary Outcome Measure Information:

Title

Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period

Description

The percentage of participants who maintained their mean Hb concentration within +/- 1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the Efficacy Evaluation Period (EEP) is reported. The EEP was from Week 17 to Week 24. The reference Hb was calculated from the mean of Hb concentrations based upon the Hb assessments at Weeks -4, -3, -2, -1, and 0.

Time Frame

EEP (Week 17 to Week 24)

Secondary Outcome Measure Information:

Title

Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period

Description

Mean change in Hb concentration between reference SVP and the EEP is reported. The SVP was at Weeks -3, -2, -1, and EEP was from Week 17 to Week 24. Participants received epoetin alfa or beta during SVP.

Time Frame

SVP (Weeks -3, -2, -1) and EEP (Week 17 to Week 24)

Title

Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP

Description

Percentage of participants maintaining Hb concentration within the range of 10.5-12.5 g/dL throughout the EEP is reported. The EEP was from Week 17 to Week 24.

Time Frame

EEP (Week 17 to Week 24)

Title

Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP

Description

Mean time spent by participants in Hb range of 10.5-12.5 g/dL during the EEP is reported. The EEP was from Week 17 to Week 24.

Time Frame

EEP (Week 17 to Week 24)

Title

Number of Participants With Any Adverse Events or Serious Adverse Events

Description

An adverse event (AE) is untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAEs) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, and congenital anomaly.

Time Frame

Up to Week 52

Title

Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP

Description

Percentage of participants requiring any dose adjustment during DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24) is reported. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either > or = 13 g/dL or < or = 9 g/dL; if the difference of 2 consecutive Hb concentrations was > or =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 10.5 to 11.5 g/dL, the difference between the reference value (mean of Hb concentrations based on the Hb assessments at Weeks -4, -3, -2, -1, and 0) and the most recent value was >1 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 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.

Time Frame

DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24)

Title

Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase

Description

Red Blood Cells (RBCs) transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP, EEP, and during the long term safety period (LTSP) were reported.

Time Frame

Up to Week 52

Title

Mean Hemoglobin Levels Over Time

Description

The Hb levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.

Time Frame