Study of Roxadustat's Effect on Anemia in Patients With Diabetic Kidney Disease

Clinical Observation of Roxadustat's Effect on Anemia in Patients With Diabetic Kidney Disease (Stage III-IV)

This study is a single-arm, open-label, multicenter and prospective study, which is conducted to evaluate the effect of Roxadustat on anemia in subjects with DKD (stage III-IV).

Study Overview

• Status: Completed
• Conditions: Anemia; Diabetic Kidney Disease
• Intervention / Treatment: Drug: Roxadustat

Detailed Description

This study will consist of three study periods as follows:

Screening Period: 2 weeks Treatment Period: 24weeks Follow-up Period: 4 weeks

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Changsha, China, 410000
    • Second Xiangya Hospital, Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Ages 18 to 60 years
2. Subject has voluntarily signed and dated an informed consent form (ICF), approved by an EC, after the nature of the study has been explained and the subject has had the opportunity to ask questions.
3. Diagnosed as Type 2 diabetic kidney disease (usually a clinical diagnosis made based on the presence of albuminuria and/or reduced eGFR in the absence of signs or symptoms of other primary causes of kidney damage), with KDOQI Stage 3 or 4 (an eGFR≧15 ml/min/1.73 m2 and <60 ml/min/1.73 m2 estimated using the CKD-EPI equation).
4. The recent Hb value during the Screening Period, must be ≥7.0 g/dL and <10 g/dL.
5. Either transferrin saturation (TSAT) ≥5% or serum ferritin ≥30 ng/mL during the screening period.
6. No use of an erythropoiesis stimulating agent for 1 week before enrolment.
7. ALT and AST ≤1.5 x ULN, and normal total bilirubin at screening visits.
8. Body weight: 40 to 100 kg inclusive.

Exclusion Criteria:

• Subjects should not enter the study if any of the following exclusion criteria are fulfilled:

  1. Chronic kidney disease attribute to cause(s) other than diabetic kidney disease.
  2. eGFR<15ml ml/min/1.73 m2 or receiving dialysis or renal transplantation.
  3. Uncontrolled severe hypertension (SBP≧180mmHg, DBP≧100mmHg).
  4. Any clinically significant infection or evidence of an active underlying infection.
  5. New York Heart Association Class III or IV congestive heart failure.
  6. Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (e.g., deep venous thrombosis or pulmonary embolism) within 24 weeks prior to Day 1.
  7. Diagnosis or suspicion (e.g., complex kidney cyst of Bosniak Category IIF or higher) of renal cell carcinoma on screening renal ultrasound.
  8. History of malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, or in situ cancer at any site.
  9. Chronic inflammatory disease that could impact erythropoiesis (e.g., SLE, rheumatoid arthritis, celiac disease).
  10. Clinically significant gastrointestinal bleeding.
  11. Known history of myelodysplastic syndrome, multiple myeloma, hereditary hematologic disease such as thalassemia, sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD, hemosiderosis, hemochromatosis, known coagulation disorder, or hypercoagulable condition.
  12. Any prior functioning organ transplant or a scheduled organ transplantation.
  13. Anticipated elective surgery that could lead to significant blood loss during the study period.
  14. Anticipated use of dapsone or acetaminophen (paracetamol) >2.0 g/day, or >500 mg per dose repeated every 6 hours for more than 3 days.
  15. Serum albumin <2.5 g/dL.
  16. Androgen, deferoxamine, deferiprone, or deferasirox therapy within 12 weeks prior to Day 1.
  17. Life expectancy of <6 months.
  18. Blood transfusion within 12 weeks prior to Day 1 or anticipated need for transfusion.
  19. IV iron supplement during the Screening Period and /or unwilling to withhold IV iron.
  20. Immune suppressive or systemic steroid treatment within 12 weeks prior to Day 1.
  21. History of alcohol or drug abuse within the past 2 years and inability to avoid consumption of more than >3 alcoholic beverages per day.
  22. Prior treatment with any HIF-PH inhibitor (HIF-PHI).
  23. Use of an investigational medication or treatment, participation in an interventional study.
  24. Women who are pregnant or breastfeeding.
  25. Women of childbearing potential and men with sexual partners of childbearing potential who are not using adequate contraception.
  26. Any medical condition that, in the opinion of the Investigator, may pose a safety risk to a subject in this study, may confound efficacy or safety assessment, or may interfere with study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Roxadustat; Oral

Drug: Roxadustat; The starting dose of Roxadustat will be defined as per the China Package Insert. The recommended starting dose of roxadustat will depend on the body weight of the patient (based on patient's empty weight prior to instillation of dialysate): 70 mg (40 to < 60 kg) tiw or 100 mg (≥ 60 kg) tiw. The frequency of hemoglobin concentration test should be ≥ once every 4 weeks. The dose will be adjusted according to the following table every 4 weeks to achieve and/or maintain hemoglobin within the target range (10.0-12.0 g/dl).; Other Names: Roxadustat capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hb level	Change in average Hb level from baseline to week 24.	at week 0,2,4,8,12,16,20,24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical parameters	SF-36 summary scores (PCS and MCS), physical functioning and vitality	test at week 0,12 and 24
serum transferrin level	Change in serum transferrin level from baseline to week 24	test at week 0,12 and 24
serum ferritin level	Change in serum ferritin level from baseline to week 24	test at week 0,12 and 24
serum TSAT level	Change in serum TSAT level from baseline to week 24	test at week 0,12 and 24
serum iron level	Change in serum iron level from baseline to week 24	test at week 0,12 and 24
FPG and PPG	Change in FPG and PPG levels from baseline to week 24	test at week 0,12 and 24
HbA1C level	Change in HbA1C level from baseline to week 24	test at week 0,12 and 24
Triglycerides, Cholesterol, HDL, LDL levels	Change in triglycerides, cholesterol, HDL, and LDL levels from baseline to week 24	test at week 0,12 and 24
apolipoprotein level	Change in apolipoprotein level from baseline to week 24	test at week 0,12 and 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
UACR	Change in UACR level from baseline to week 24	test at week 0,2,4,8,12,16,20,24
serum creatinine	Change in serum creatinine level from baseline to week 24	test at week 0,2,4,8,12,16,20,24
uric acid	Change in uric acid level from baseline to week 24	test at week 0,2,4,8,12,16,20,24
eGFR	Change in eGFR from baseline to week 24	test at week 0,2,4,8,12,16,20,24
urine-NGAL	Change in urine-NGAL level from baseline to week 24	test at week 0,24
24h-urinalysis	Change in 24h-urinalysis from baseline to week 24	test at week 0,24

Collaborators and Investigators

• Sponsor: Second Xiangya Hospital of Central South University
• Collaborators: Xiangya Hospital of Central South University; The Third Xiangya Hospital of Central South University
• Investigators: Principal Investigator: Lin Sun, doctor, Department of Nephrology, Second Xiangya hospital of central south university, Changsha, China.

Publications and helpful links

General Publications

• Chen N, Hao C, Peng X, Lin H, Yin A, Hao L, Tao Y, Liang X, Liu Z, Xing C, Chen J, Luo L, Zuo L, Liao Y, Liu BC, Leong R, Wang C, Liu C, Neff T, Szczech L, Yu KP. Roxadustat for Anemia in Patients with Kidney Disease Not Receiving Dialysis. N Engl J Med. 2019 Sep 12;381(11):1001-1010. doi: 10.1056/NEJMoa1813599. Epub 2019 Jul 24.
• Chen N, Hao C, Liu BC, Lin H, Wang C, Xing C, Liang X, Jiang G, Liu Z, Li X, Zuo L, Luo L, Wang J, Zhao MH, Liu Z, Cai GY, Hao L, Leong R, Wang C, Liu C, Neff T, Szczech L, Yu KP. Roxadustat Treatment for Anemia in Patients Undergoing Long-Term Dialysis. N Engl J Med. 2019 Sep 12;381(11):1011-1022. doi: 10.1056/NEJMoa1901713. Epub 2019 Jul 24.
• Yan Z, Xu G. A Novel Choice to Correct Inflammation-Induced Anemia in CKD: Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor Roxadustat. Front Med (Lausanne). 2020 Aug 6;7:393. doi: 10.3389/fmed.2020.00393. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): July 8, 2024

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Diabetes Mellitus; Diabetes Complications; Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia; Diabetic Nephropathies; roxadustat
• Other Study ID Numbers: ESR-20-20537

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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