A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

November 2, 2017 updated by: Hoffmann-La Roche

A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous MIRCERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

This single arm study will evaluate the maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in dialysis patients with chronic renal anemia. Patients will receive intravenous Mircera (120, 200 or 360 micrograms) every four weeks depending on the previous dose of epoetin alfa administered in the week preceding first study drug administration. Patients will be treated for 12 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.
132

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
      • Bangalore, India, 560017
        • Manipal Institute of Nephrology and Urology; Nephrology
      • Bangalore, India, 560024
        • Columbia Asia Medical Centre - Hebbal; Nephrology
      • Chennai, India, 600 037
        • Tanker Foundation
      • Chennai, India, 6000089
        • MIOT Institute of Nephrology ; Nephrology
      • Chennai, India, 600037
        • Madras Medical Mission Hospital
      • Guwahati, India, 781005
        • International Hospital
      • Hyderabad, India, 500068
        • Kamineni Hospitals; Nephrology
      • Hyderabad, India, 500082
        • Nizam's Institute of Medical Sciences; Nephrology
      • Kanpur, India, 208005
        • Regency Hospital Ltd.; Nephrology
      • Kolkata, India, 700029
        • Wockhardt Hospital and Kidney Institute; Nephrology
      • Meerut, India, 250001
        • Meerut Kidney Hospital
      • Mohali, India, 160 063
        • Silver Oaks Hospital; Nephrology
      • Mumbai, India, 400080
        • Apex Kidney Care
      • Mumbai, India, 400092
        • Lancelot Dialysis Center
      • New Delhi, India, 110070
        • Fortis Flt. Lt. Rajan Dhall Hospital; Nephrology
      • Pune, India, 411 001
        • Ruby Hall Clinic
    • Delhi
      • New Delhi, Delhi, India, 110076
        • Indraprastha Apollo Hospitals

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 10.5g/dL - 12.5g/dL;
  • continuous intravenous maintenance therapy with epoetin alfa at the same dosing interval during the previous 2 months.

Exclusion Criteria:

  • blood transfusion within the previous 2 months;
  • 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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
Participant with chronic renal anemia will receive methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
iv (120, 200 or 360 micrograms) every 4 weeks for 12 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
Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)
Time Frame: Weeks 8 to 12 (Last 4 weeks of treatment period)
Participants maintaining mean hemoglobin (Hb) concentration within the target range i.e. 10.0 - 12.0 gram per deciliter (g/dL) during last 4 weeks (Weeks 8 to 12) of treatment period (TP) were reported. Total duration for treatment period was 12 weeks. Stability verification period of 2-weeks was conducted before treatment period. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value Hb +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.
Weeks 8 to 12 (Last 4 weeks of treatment period)

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 Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12)
Time Frame: SVP (Weeks -2 to -1) and TP (Weeks 8 to 12)
The mean change in Hb concentration between reference stability verification period (SVP) and in last 4 weeks (Weeks 8 to 12) of treatment period (TP) was reported. Duration for SVP was 2 weeks followed by treatment period of 12 weeks. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.
SVP (Weeks -2 to -1) and TP (Weeks 8 to 12)
Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL
Time Frame: Up to Week 12
Mean time participants spent having hemoglobin range of 10.0 to 12.0 g/dL was reported. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 gram per deciliter but not >12.0 g/dL and not <10.0 g/dL.
Up to Week 12
Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths
Time Frame: Up to Week 14
Participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and deaths in the overall study were reported. 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.
Up to Week 14
Mean Change From Baseline in Heart Rate Over Time
Time Frame: From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12
Mean change from Baseline (Week -1) to end of the treatment (Week 12) in heart rate was reported. Baseline measure was considered as (Week -1) evaluation for this parameter.
From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
Time Frame: From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12
Mean change from Baseline (Week -2) to end of the treatment (Week 12) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) before and after dialysis was reported. Baseline measure was considered as (Week -2) evaluation for this parameter.
From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12
Number of Participants With Abnormal Electrocardiogram
Time Frame: At Week -2 and Week 12
Participants with abnormal electrocardiogram were reported.
At Week -2 and Week 12
Mean Values of White Blood Cells and Platelets Over Time
Time Frame: At Weeks -2, 4, 8, and 12
Mean values of white blood cells (WBCs), and platelets at Weeks -2, 4, 8, and 12 were reported.
At Weeks -2, 4, 8, and 12
Mean Values of Hypochromic Red Blood Cells Over Time
Time Frame: At Weeks -2, 4, 8, and 12
Mean values of hypochromic red blood cells (RBCs) at Weeks -2, 4, 8, and 12 were reported.
At Weeks -2, 4, 8, and 12
Mean Corpuscular Volume Levels Over Time
Time Frame: At Weeks -2, 4, 8, and 12
Mean corpuscular volume (MCV) is a measure of the average red blood cell volume. MCV levels at Weeks -2, 4, 8, and 12 were reported.
At Weeks -2, 4, 8, and 12
Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time
Time Frame: At Weeks -2, 4, 8, and 12
Mean values of serum iron and total iron binding capacity (TIBC) were reported.
At Weeks -2, 4, 8, and 12
Mean Values of Serum Ferritin Over Time
Time Frame: At Weeks -2, 4, 8, and 12
Mean values of serum ferritin were reported.
At Weeks -2, 4, 8, and 12
Mean Values of Transferrin Over Time
Time Frame: At Weeks -2, 4, 8, and 12
Mean values of transferrin were reported.
At Weeks -2, 4, 8, and 12
Mean Values of Transferrin Saturation Over Time
Time Frame: At Weeks -2, 4, 8, and 12
Mean values of Transferrin Saturation (TSAT) were reported.
At Weeks -2, 4, 8, and 12
Mean Values of Serum Albumin and Serum Globulin Over Time
Time Frame: At Weeks -2, 4, 8, and 12
Mean values of serum albumin and serum globulin were reported.
At Weeks -2, 4, 8, and 12
Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time
Time Frame: At Weeks -2, 4, 8, and 12
Mean values of aspartate aminotransferase (AST), alanine transaminase (ALT) and serum alkaline phosphatase were reported.
At Weeks -2, 4, 8, and 12
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
Time Frame: At Weeks -2, 4, 8, and 12
Mean values of serum creatinine, blood urea nitrogen (BUN), serum phosphate and serum bilirubin were reported.
At Weeks -2, 4, 8, and 12
Mean Values of Serum Sodium and Serum Potassium Over Time
Time Frame: At Weeks -2, 4, 8, and 12
Mean values of serum sodium and serum potassium were reported.
At Weeks -2, 4, 8, and 12

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 (Actual)

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.
August 26, 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.
September 12, 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.
September 12, 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 (Actual)

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.
December 7, 2017

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.
November 2, 2017

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.
November 1, 2017

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.
  • ML21810

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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