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

NCT07359027 | Completed Phase 4

• 1 other identifier: ESR-20-20537
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Anemia; Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Hb level

  Change in average Hb level from baseline to week 24.

  at week 0,2,4,8,12,16,20,24

Secondary Outcomes (9)

• serum transferrin level

  test at week 0,12 and 24

• serum ferritin level

  test at week 0,12 and 24

• serum TSAT level

  test at week 0,12 and 24

• serum iron level

  test at week 0,12 and 24

• FPG and PPG

  test at week 0,12 and 24

Other Outcomes (6)

• UACR

  test at week 0,2,4,8,12,16,20,24

• serum creatinine

  test at week 0,2,4,8,12,16,20,24

• uric acid

  test at week 0,2,4,8,12,16,20,24

Study Arms (1)

Roxadustat

EXPERIMENTAL

Oral

Drug: Roxadustat

Interventions

Roxadustat DRUG

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).

Also known as: Roxadustat capsules

Roxadustat

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18 to 60 years
• 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.
• 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).
• The recent Hb value during the Screening Period, must be ≥7.0 g/dL and \<10 g/dL.
• Either transferrin saturation (TSAT) ≥5% or serum ferritin ≥30 ng/mL during the screening period.
• No use of an erythropoiesis stimulating agent for 1 week before enrolment.
• ALT and AST ≤1.5 x ULN, and normal total bilirubin at screening visits.
• Body weight: 40 to 100 kg inclusive.

You may not qualify if:

• Chronic kidney disease attribute to cause(s) other than diabetic kidney disease.
• eGFR\<15ml ml/min/1.73 m2 or receiving dialysis or renal transplantation.
• Uncontrolled severe hypertension (SBP≧180mmHg, DBP≧100mmHg).
• Any clinically significant infection or evidence of an active underlying infection.
• New York Heart Association Class III or IV congestive heart failure.
• 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.
• Diagnosis or suspicion (e.g., complex kidney cyst of Bosniak Category IIF or higher) of renal cell carcinoma on screening renal ultrasound.
• 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.
• Chronic inflammatory disease that could impact erythropoiesis (e.g., SLE, rheumatoid arthritis, celiac disease).
• Clinically significant gastrointestinal bleeding.
• 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.
• Any prior functioning organ transplant or a scheduled organ transplantation.
• Anticipated elective surgery that could lead to significant blood loss during the study period.
• 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.
• Serum albumin \<2.5 g/dL.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: collaborator
• The Third Xiangya Hospital of Central South University: collaborator
• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

Second Xiangya Hospital, Central South University

Changsha, 410000, China

Location

Related Publications (3)

• 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.

  PMID: 31340089 BACKGROUND

• 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.

  PMID: 31340116 BACKGROUND

• 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.

  PMID: 32850902 BACKGROUND

MeSH Terms

Conditions

Diabetic Nephropathies; Anemia

Interventions

roxadustat

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Lin Sun, doctor

  Department of Nephrology, Second Xiangya hospital of central south university, Changsha, China.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: January 22, 2026
• Study Start: November 2, 2021
• Primary Completion: December 31, 2022
• Study Completion: July 8, 2024
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)