Roxadustat for Anemia in Patients With CKD

January 19, 2021 updated by: Shenzhen Second People's Hospital

A Prospective Cohort Study of Roxadustat for Anemia in Patients With Chronic Kidney Disease

A number of RCT studies have shown the safety and effectiveness of oral Roxadustat in the treatment of renal anemia, but there is a lack of evidence from cohort studies. A prospective cohort study is planed to conduct to evaluate the efficacy and safety of Roxadustat for renal anemia in the real world.

Study Overview

Status

Status

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

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.

Detailed Description

The prevalence of anemia in patients with chronic kidney disease (CKD) (15.4%) is twice that of the general population (7.6%), and the degree of anemia increases with the severity of CKD. A number of RCT studies have shown the safety and effectiveness of oral Roxadustat in the treatment of renal anemia, but there is a lack of evidence from cohort studies. A prospective cohort study is planed to conduct to evaluate the efficacy and safety of Roxadustat for renal anemia in the real world. It is planned to continuously recruit patients with renal anemia in Shenzhen Second People's Hospital from October 2020 to June 2023. The treatment of anemia will be recorded (Roxadustat or erythropoietin), and the observation period is one year. Collect the patient's demographic characteristics, drug dosage, adjustment plan, hemoglobin. The main outcome indicators were: the average change in Hb from baseline to 28-52 weeks, and the Hb response rate reached during two consecutive visits; the secondary outcome indicators were: the maintenance rate of the target Hb level, iron metabolism indicators, 0 to 8 weeks of Hb level increase rate, dose adjustment and safety indicators. The generalized additive mixed model of repeated measures was used to analyze the changes and differences of outcome indicators in different groups. Expected results: In the cohort study, the effectiveness and safety of roxastat in the treatment of renal anemia, the starting dose and the adjustment plan, provide a basis for guiding the clinical safe and effective application of roxastat.

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.
Observational

Enrollment (Anticipated)

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.
200

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Shenzhen, China
        • Recruiting
        • Shenzhen Second People's Hospital
        • Contact:
          • Yuan Cheng

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

Sampling Method

Non-Probability Sample

Study Population

Renal anemia patients who are naïve to roxadustat or ESA

Description

Inclusion Criteria:

  1. the patient did not receive ESA treatment.The average Hb level of the last two (at least 7 days before the start of the study treatment and during the screening period) was <10 g/dL.

    Or patients who have received ESA:

    Patients with renal anemia who received ESA for at least 4 weeks within the approved dose range in China before the screening evaluation.

  2. The average Hb level of the last two (at least 7 days before the start of the study treatment and during the screening period) >=7 g/dL and <=12.0 g/dL;
  3. The expected survival time is more than 1 year;

Exclusion Criteria:

  1. a history of severe, chronic, end-stage or uncontrolled autoimmune liver disease, Child Pugh score was grade C, or with active hepatitis;
  2. preparing for pregnancy or pregnancy or lactation;
  3. having anemia caused by any other disease other than CKD, such as thalassemia, sickle cell anemia, pure red aplastic anemia, hemolytic anemia, tumor-related anemia, chemotherapy-related anemia, and myelodysplastic syndrome;
  4. malignant tumor, such as prostate cancer, breast cancer, renal cell cancer or any other malignant tumor history or diagnosed
  5. .Any red blood cell infusion during the screening period;
  6. The patient is known to be allergic to the active substance (Roxadustat) or any excipient of the product;

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Roxadustat
treatment with roxadustat
Drug: Roxadustat
Oral
Other Names:
  • Roxadustat capsules
erythropoietin
treatment with erythropoietin
Drug: erythropoietin
injection
Other Names:
  • Recombinant Human Erythropoietin Injection(CHO cell)

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 value of Hb levels over time
Time Frame: Up to Week 52
Hb will be measured throughout the period.
Up to Week 52
Achievement rate for target Hb level
Time Frame: Up to Week 52
Percent of participants who achieved target Hb level (≥10.0 ).
Up to Week 52

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 Hb levels at 4 weeks after using roxadustat
Time Frame: At Week 4
Hb levels at 4 weeks after using roxadustat
At Week 4
Mean Hb levels at 8 weeks after using roxadustat
Time Frame: At Week 8
Hb levels at 8 weeks after using roxadustat
At Week 8
the dose of Roxadustat used
Time Frame: Up to Week 52
the dose of Roxadustat used recorded monthly
Up to Week 52
Change from baseline in Hemoglobin (Hb) levels
Time Frame: Up to Week 52
Change from baseline in Hemoglobin (Hb) levels was recorded monthly
Up to Week 52
the proportion of patients with different Hb levels
Time Frame: Up to Week 52
the proportion of patients with different Hb levels
Up to Week 52
The proportion of patients with low response to ESA
Time Frame: Up to Week 52
The proportion of patients with low response to ESA
Up to Week 52
Concentration of Serum iron
Time Frame: Up to Week 52
Serum iron will be measured throughout the period.
Up to Week 52
Number of Participants with adverse events
Time Frame: Up to Week 52
adverse events will be record throughout the period.
Up to Week 52

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.
Shenzhen Second People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yuan Cheng, Dr., Shenzhen Second People's Hospital

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 (ANTICIPATED)

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.
February 1, 2021

Primary Completion (ANTICIPATED)

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.
June 30, 2023

Study Completion (ANTICIPATED)

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 30, 2023

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 3, 2020

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 3, 2020

First Posted (ACTUAL)

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 6, 2020

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.
January 22, 2021

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.
January 19, 2021

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.
October 1, 2020

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.
  • 20203357012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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