Roxadustat for Anemia in Patients With CKD

NCT ID: NCT04502537

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2023-09-30

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Roxadustat

treatment with roxadustat

Roxadustat

Intervention Type: DRUG

Oral

erythropoietin

treatment with erythropoietin

erythropoietin

Intervention Type: DRUG

injection

Interventions

Roxadustat

Oral

Intervention Type: DRUG

erythropoietin

injection

Intervention Type: DRUG

Other Intervention Names

Roxadustat capsules; Recombinant Human Erythropoietin Injection(CHO cell)

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Second People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuan Cheng, Dr.

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Second People's Hospital

Locations

Shenzhen Second People's Hospital

Shenzhen, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuan Cheng, Dr.

Role: CONTACT

chengy_nephrology@163.com

86075583366388

Qijun Wan, Dr.

Role: CONTACT

yiyuan2224@sina.com

86075583366388

Facility Contacts

Yuan Cheng

Role: primary

Other Identifiers

20203357012

Identifier Type: -

Identifier Source: org_study_id