Roxadustat for Anemia in Patients With CKD

Shenzhen University

Status: Unknown

Conditions: Anemia of Chronic Kidney Disease

Treatments: Drug: Roxadustat; Drug: erythropoietin

Study type: Observational

Funder types: Other

Identifiers

NCT04502537

20203357012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

200 participants in 2 patient groups

Roxadustat

Description:

treatment with roxadustat

Treatment:

Drug: Roxadustat

erythropoietin

Description:

treatment with erythropoietin

Treatment:

Drug: erythropoietin