AzTrials
AzTrials

Diabetic Kidney DiseasePhase 4NCT07359027

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

A Phase 4 study testing Roxadustat in people with Diabetic Kidney Disease and Anemia, run by Second Xiangya Hospital of Central South University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diabetic Kidney Disease, Anemia
What is being tested?
Roxadustat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteChina
Study dates
2 Nov 2021to 8 Jul 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
  • 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.
Show all 27Show fewer
  • 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.
  • Androgen, deferoxamine, deferiprone, or deferasirox therapy within 12 weeks prior to Day 1.
  • Life expectancy of <6 months.
  • Blood transfusion within 12 weeks prior to Day 1 or anticipated need for transfusion.
  • IV iron supplement during the Screening Period and /or unwilling to withhold IV iron.
  • Immune suppressive or systemic steroid treatment within 12 weeks prior to Day 1.
  • History of alcohol or drug abuse within the past 2 years and inability to avoid consumption of more than >3 alcoholic beverages per day.
  • Prior treatment with any HIF-PH inhibitor (HIF-PHI).
  • Use of an investigational medication or treatment, participation in an interventional study.
  • Women who are pregnant or breastfeeding.
  • Women of childbearing potential and men with sexual partners of childbearing potential who are not using adequate contraception.
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Second Xiangya Hospital, Central South University

    Changsha, 410000

Other trials in China

About this study

Official title: 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).

Read the detailed description

This study will consist of three study periods as follows:

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

Being tested
Roxadustat
Medical subject headings
Diabetic Nephropathies, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RoxadustatDrug

    Also called Roxadustat capsules

    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).

Study groups in NCT07359027
Study groupRoleWhat they receive
RoxadustatExperimentalOral
Receives: Drug: Roxadustat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hb level

    Change in average Hb level from baseline to week 24.

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

Secondary outcomes (9)

  1. serum transferrin level

    Change in serum transferrin level from baseline to week 24

    Measured: test at week 0,12 and 24

  2. serum ferritin level

    Change in serum ferritin level from baseline to week 24

    Measured: test at week 0,12 and 24

  3. serum TSAT level

    Change in serum TSAT level from baseline to week 24

    Measured: test at week 0,12 and 24

  4. serum iron level

    Change in serum iron level from baseline to week 24

    Measured: test at week 0,12 and 24

  5. FPG and PPG

    Change in FPG and PPG levels from baseline to week 24

    Measured: test at week 0,12 and 24

  6. HbA1C level

    Change in HbA1C level from baseline to week 24

    Measured: test at week 0,12 and 24

  7. Triglycerides, Cholesterol, HDL, LDL levels

    Change in triglycerides, cholesterol, HDL, and LDL levels from baseline to week 24

    Measured: test at week 0,12 and 24

  8. apolipoprotein level

    Change in apolipoprotein level from baseline to week 24

    Measured: test at week 0,12 and 24

  9. Physical parameters

    SF-36 summary scores (PCS and MCS), physical functioning and vitality

    Measured: test at week 0,12 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2026
  2. Study start2 Nov 2021
  3. Primary completion31 Dec 2022
  4. Study completion8 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07359027
Sponsor's protocol ID
ESR-20-20537
Status last verified
Jan 2026
First submitted
6 Sep 2022
Last updated
26 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 31340089

  • 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.

    PubMed 31340116

  • 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.

    PubMed 32850902

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Roxadustat in people with Diabetic Kidney Disease and Anemia, run by Second Xiangya Hospital of Central South University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hb level (time frame: at week 0,2,4,8,12,16,20,24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07359027, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in