Roxadustat for Anemia in Patients With CKD

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.

Study Overview

• Status: Recruiting
• Conditions: Anemia of Chronic Kidney Disease
• Intervention / Treatment: Drug: Roxadustat; Drug: erythropoietin

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Yuan Cheng, Dr.; Phone Number: 86075583366388; Email: chengy_nephrology@163.com
• Study Contact Backup: Name: Qijun Wan, Dr.; Phone Number: 86075583366388; Email: yiyuan2224@sina.com

Study Locations

• China
  • Shenzhen, China
    • Recruiting
    • Shenzhen Second People's Hospital
    • Contact: Yuan Cheng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Renal anemia patients who are naïve to roxadustat or ESA

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Roxadustat; treatment with roxadustat	Drug: Roxadustat; Oral; Other Names: Roxadustat capsules
erythropoietin; treatment with erythropoietin	Drug: erythropoietin; injection; Other Names: Recombinant Human Erythropoietin Injection(CHO cell)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shenzhen Second People's Hospital
• Investigators: Principal Investigator: Yuan Cheng, Dr., Shenzhen Second People's Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2021
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): September 30, 2023

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (ACTUAL): August 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Hematologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: 20203357012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No