Roxadustat for Anemia in Patients With CKD

• Conditions: Anemia of Chronic Kidney Disease
• Interventions: Drug: Roxadustat; Drug: erythropoietin

• Registration Number: NCT04502537
• Lead Sponsor: Shenzhen Second People's Hospital

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.

Study Timeline

• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-06
• Status Verified: 2020-10
• Last Update Submitted: 2021-01-19
• Last Update Posted: 2021-01-22
• Study Start: 2021-02-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Roxadustat	Roxadustat	treatment with roxadustat
erythropoietin	erythropoietin	treatment with erythropoietin

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shenzhen Second People's Hospital; 🇨🇳 Shenzhen, China