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

April 26, 2016 updated by: Hoffmann-La Roche

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).

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
189

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Ahmedabad, India, 380007
      • Bangalore, India, 560034
      • Chennai, India, 603103
      • Coimbatore, India, 641004
      • Gujarat, India, 387 001
      • Hyderabad, India, 500001
      • Kerala, India, 682017
      • Kolkata, India, 700099
      • Ludhiana, India
      • Mumbai, India
      • Mumbai, India, 400026
      • New Delhi, India, 110 060
      • New Delhi, India, 110017
      • New Delhi, India, 110026
      • Vellore, India, 632 004
      • Vishakpatnam, India, 530002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Mircera
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
iv 0.6 micrograms/kg every 2 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period
Time Frame: 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.
Baseline (Week 0) and Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter
Time Frame: 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.
Up to Week 16
Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16
Time Frame: 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.
Week 12 to Week 16
Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16
Time Frame: 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.
Week 12 to Week 16
Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Time Frame: 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
Up to Week 18
Number of Participants With Abnormal Electrocardiogram
Time Frame: Up to Week 16
Twelve-lead electrocardiogram (ECG) was recorded for the participants. The number of participants with abnormal ECG is presented.
Up to Week 16
Number of Participants With Reports of Blood Transfusions
Time Frame: Up to Week 16
Indications for blood transfusions were acute blood loss (bleeding), lack of treatment response or treatment failure, or other reasons.
Up to Week 16
Number of Participants With Reports of Anti-Epoetin Antibodies
Time Frame: Up to Week 16
Participants were assessed for the presence of Anti-Epoetin antibodies for MIRCERA.
Up to Week 16
Mean White Blood Cell Count Over Time
Time Frame: 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.
Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Value of Mean Corpuscular Volume Over Time
Time Frame: 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.
Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Hypochromic Red Blood Cells Over Time
Time Frame: 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.
Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Platelet Count Over Time
Time Frame: 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.
Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Iron Over Time
Time Frame: 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.
Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Ferritin Over Time
Time Frame: 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.
Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Transferrin Over Time
Time Frame: 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.
Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Total Iron-binding Capacity Over Time
Time Frame: 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.
Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Transferrin Saturation Over Time
Time Frame: 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.
Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Albumin Over Time
Time Frame: 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.
Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Globulin Over Time
Time Frame: 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.
Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Creatinine Over Time
Time Frame: 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.
Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Blood Urea Nitrogen Over Time
Time Frame: 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.
Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Potassium Over Time
Time Frame: 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.
Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Sodium Over Time
Time Frame: 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.
Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Phosphate Over Time
Time Frame: 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.
Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Bilirubin Over Time
Time Frame: 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.
Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Aspartate Transaminase Over Time
Time Frame: 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.
Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Alanine Aminotransferase Over Time
Time Frame: 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.
Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Alkaline Phosphatase Over Time
Time Frame: 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.
Baseline (Week 0), Week 4, Week 10, and Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2009

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML21822

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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