A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia

June 15, 2017 updated by: Hoffmann-La Roche

A Single Arm, Open Label, Multicenter Phase IIIb/IV Clinical Trial to Assess the Efficacy, Safety and Tolerability of Monthly Administration of C.E.R.A. for the Treatment of Not on Dialysis Chronic Renal Anemia Not Currently Treated With ESA

This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on dialysis. Patients will receive as a recommended starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is dependent on the patient's weight. Dose adjustment may be required due to inadequate or excessive treatment response. The anticipated time on study treatment is 28 weeks.

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.
70

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

  • Egypt
      • Alexandria, Egypt
        • Alexandria University; Endocrinology Department
      • Cairo, Egypt
        • Nasser Institute
      • Cairo, Egypt
        • El Qahira Al Fatemeya Hospital
      • Cairo, Egypt
        • Kasr El Ainy University Hospital; Endocrinology Department
      • Mansoura, Egypt
        • Mansoura Kidney Center; Nephrology

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:

  • Adult patients, age >/=18 years
  • Diagnosis of chronic renal anemia
  • Not on dialysis
  • Hemoglobin concentration <10 g/dl
  • No erythropoiesis stimulating agent (ESA) therapy during the 3 months before study start
  • Estimated glomerular filtration rate (EGFR) <60 ml/min and >/=20 ml/min
  • Adequate iron status

Exclusion Criteria:

  • Transfusion of red blood cells during the previous 2 months
  • Poorly controlled hypertension
  • Significant acute or chronic bleeding, e.g. gastrointestinal bleeding
  • Active malignant disease (except non-melanoma skin cancer)
  • Hemolysis
  • Hemoglobinopathies, e.g. sickle-cell disease, thalassemia

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: Single Arm
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Recommended starting dose 1.2 micrograms/kg subcutaneously every 4 weeks (depending on patient's weight). Dose adjustment may be required in the event of inadequate or excessive treatment response.

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
Change From Baseline in Mean Hb Concentration at Week 20
Time Frame: Baseline (Week 0), Week 20
Per Protocol (PP) Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin less than or equal to [≤] 100 nanogram per milliliter [ng/mL] or mean transferrin saturation [TSAT] ≤20% or mean hypochromic red blood cells [RBCs] greater than or equal to [≥] 10% during efficacy evaluation period [Weeks 20 to 28]).
Baseline (Week 0), Week 20
Change From Baseline in Mean Hb Concentration at Week 24
Time Frame: Baseline (Week 0), Week 24
PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).
Baseline (Week 0), Week 24
Change From Baseline in Mean Hb Concentration at Week 28
Time Frame: Baseline (Week 0), Week 28
PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).
Baseline (Week 0), Week 28

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.
July 18, 2011

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.
November 30, 2012

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.
November 30, 2012

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).
April 20, 2011

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.
April 26, 2011

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.
April 27, 2011

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.
July 12, 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.
June 15, 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.
June 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.
  • ML25300

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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