Anemia of Chronic Kidney DiseaseNCT04502537
Roxadustat for Anemia in Patients With CKD
An observational study of Anemia of Chronic Kidney Disease, run by Shenzhen Second People's Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia of Chronic Kidney Disease
- What is being tested?
- Roxadustat and erythropoietin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Renal anemia patients who are naïve to roxadustat or ESA
Who may be able to join
- 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.
- 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;
- The expected survival time is more than 1 year;
Who cannot join
- a history of severe, chronic, end-stage or uncontrolled autoimmune liver disease, Child Pugh score was grade C, or with active hepatitis;
- preparing for pregnancy or pregnancy or lactation;
- 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;
- malignant tumor, such as prostate cancer, breast cancer, renal cell cancer or any other malignant tumor history or diagnosed
- .Any red blood cell infusion during the screening period;
- The patient is known to be allergic to the active substance (Roxadustat) or any excipient of the product;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen Second People's Hospital
Shenzhen
Yuan Cheng
About this study
Official title: 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.
Read the 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.
- Conditions
- Anemia of Chronic Kidney Disease
- Being tested
- Roxadustat, erythropoietin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoxadustatDrug
Also called Roxadustat capsules
Oral
erythropoietinDrug
Also called Recombinant Human Erythropoietin Injection(CHO cell)
injection
| Study group | Role | What they receive |
|---|---|---|
| Roxadustat | treatment with roxadustat Receives: Drug: Roxadustat | |
| erythropoietin | treatment with erythropoietin Receives: Drug: erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean value of Hb levels over time
Hb will be measured throughout the period.
Measured: Up to Week 52
Achievement rate for target Hb level
Percent of participants who achieved target Hb level (≥10.0 ).
Measured: Up to Week 52
Secondary outcomes (8)
Mean Hb levels at 4 weeks after using roxadustat
Hb levels at 4 weeks after using roxadustat
Measured: At Week 4
Mean Hb levels at 8 weeks after using roxadustat
Hb levels at 8 weeks after using roxadustat
Measured: At Week 8
the dose of Roxadustat used
the dose of Roxadustat used recorded monthly
Measured: Up to Week 52
Change from baseline in Hemoglobin (Hb) levels
Change from baseline in Hemoglobin (Hb) levels was recorded monthly
Measured: Up to Week 52
the proportion of patients with different Hb levels
the proportion of patients with different Hb levels
Measured: Up to Week 52
The proportion of patients with low response to ESA
The proportion of patients with low response to ESA
Measured: Up to Week 52
Concentration of Serum iron
Serum iron will be measured throughout the period.
Measured: Up to Week 52
Number of Participants with adverse events
adverse events will be record throughout the period.
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 Feb 2021 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia of Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuan Cheng, Dr., Principal investigator, Shenzhen Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502537
- Sponsor's protocol ID
- 20203357012
- Status last verified
- Oct 2020
- First submitted
- 3 Aug 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Roxadustat for Anemia in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04502537
- Acronym / sponsor ID
- 20203357012
- Conditions
- Anemia of Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roxadustat | – | Drug: Roxadustattreatment with roxadustat |
| erythropoietin | – | Drug: erythropoietintreatment with erythropoietin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Renal anemia patients who are naïve to roxadustat or ESA
Key inclusion criteria (5 listed)
- 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.
- Patients with renal anemia who received ESA for at least 4 weeks within the approved dose range in China before the screening evaluation.
- 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;
- The expected survival time is more than 1 year;
Key exclusion criteria (6 listed)
- a history of severe, chronic, end-stage or uncontrolled autoimmune liver disease, Child Pugh score was grade C, or with active hepatitis;
- preparing for pregnancy or pregnancy or lactation;
- 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;
- malignant tumor, such as prostate cancer, breast cancer, renal cell cancer or any other malignant tumor history or diagnosed
- .Any red blood cell infusion during the screening period;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RoxadustatAlso: Roxadustat capsulesOral | Drug | Roxadustat |
| erythropoietinAlso: Recombinant Human Erythropoietin Injection(CHO cell)injection | Drug | erythropoietin |
Primary outcome
Mean value of Hb levels over time
Time frame: Up to Week 52
Hb will be measured throughout the period.
Achievement rate for target Hb level
Time frame: Up to Week 52
Percent of participants who achieved target Hb level (≥10.0 ).
8 secondary outcomes
Mean Hb levels at 4 weeks after using roxadustat
Time frame: At Week 4
Mean Hb levels at 8 weeks after using roxadustat
Time frame: At Week 8
the dose of Roxadustat used
Time frame: Up to Week 52
Change from baseline in Hemoglobin (Hb) levels
Time frame: Up to Week 52
the proportion of patients with different Hb levels
Time frame: Up to Week 52
The proportion of patients with low response to ESA
Time frame: Up to Week 52
Concentration of Serum iron
Time frame: Up to Week 52
Number of Participants with adverse events
Time frame: Up to Week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuan Cheng, Dr. principal investigator
Shenzhen Second People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia of Chronic Kidney Disease, run by Shenzhen Second People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan Cheng, Dr. (86075583366388, chengy_nephrology@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean value of Hb levels over time (time frame: Up to Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.