Clinical trial NCT04502537: Roxadustat for Anemia in Patients With CKD
Official title: A Prospective Cohort Study of Roxadustat for Anemia in Patients With Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anemia of Chronic Kidney Disease
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Renal anemia patients who are naïve to roxadustat or ESA

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.

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;

Primary outcomes:
measure: Mean value of Hb levels over time
timeFrame: Up to Week 52
measure: Achievement rate for target Hb level
timeFrame: Up to Week 52
Secondary outcomes:
measure: Mean Hb levels at 4 weeks after using roxadustat
timeFrame: At Week 4
measure: Mean Hb levels at 8 weeks after using roxadustat
timeFrame: At Week 8
measure: the dose of Roxadustat used
timeFrame: Up to Week 52
measure: Change from baseline in Hemoglobin (Hb) levels
timeFrame: Up to Week 52
measure: the proportion of patients with different Hb levels
timeFrame: Up to Week 52
measure: The proportion of patients with low response to ESA
timeFrame: Up to Week 52
measure: Concentration of Serum iron
timeFrame: Up to Week 52
measure: Number of Participants with adverse events
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
Study officials:
affiliation: Shenzhen Second People's Hospital
name: Yuan Cheng, Dr.
role: PRINCIPAL_INVESTIGATOR
References: