Roxadustat for Anemia in Patients With CKD

Anemia of Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04502537
• Other study ID #: 20203357012
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2020
• Source: Shenzhen Second People's Hospital
• Contact: Yuan Cheng, Dr.
• Phone: 86075583366388
• Email: chengy_nephrology[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Anemia
• Anemia of Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Roxadustat
Oral
• erythropoietin
injection

Locations

Country	Name	City	State
China	Shenzhen Second People's Hospital	Shenzhen

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean value of Hb levels over time	Hb will be measured throughout the period.	Up to Week 52
Primary	Achievement rate for target Hb level	Percent of participants who achieved target Hb level (=10.0 ).	Up to Week 52
Secondary	Mean Hb levels at 4 weeks after using roxadustat	Hb levels at 4 weeks after using roxadustat	At Week 4
Secondary	Mean Hb levels at 8 weeks after using roxadustat	Hb levels at 8 weeks after using roxadustat	At Week 8
Secondary	the dose of Roxadustat used	the dose of Roxadustat used recorded monthly	Up to Week 52
Secondary	Change from baseline in Hemoglobin (Hb) levels	Change from baseline in Hemoglobin (Hb) levels was recorded monthly	Up to Week 52
Secondary	the proportion of patients with different Hb levels	the proportion of patients with different Hb levels	Up to Week 52
Secondary	The proportion of patients with low response to ESA	The proportion of patients with low response to ESA	Up to Week 52
Secondary	Concentration of Serum iron	Serum iron will be measured throughout the period.	Up to Week 52
Secondary	Number of Participants with adverse events	adverse events will be record throughout the period.	Up to Week 52