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Efficacy of Enarodustat on Anemia in CKD

Efficacy of Enarodustat on Anemia in CKD

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400082201
Enrollment
Unknown
Registered
2024-03-22
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal anemia

Interventions

Enarodustat group:NA

Sponsors

Shenzhen Second People's Hospital, the First Affiliated Hospital of Shenzhen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients signed informed consent file; 2. Patients diagnosed with renal anemia; 3. Aged >= 18 years; 4. The mean of the 2 most recent central laboratory hemoglobin (hemoglobin) values during the Screening Period, obtained at least 7 days apart, must have been 60-120 g/L, noninclusive. 5.Patients received Enarodustat or Roxadustat. 6.The expected survival time is more than one year.

Exclusion criteria

Exclusion criteria: 1.Patients with malignant tumor,such as prostate cancer, breast cancer, renal cell carcinoma, etc. 2.Patients with severe liver damage (Child Pugh grade C) or active hepatitis; 3.Women who are pregnant or breastfeeding; 4.Known causes for anemia other than CKD, hemosiderosis,hemochromatosis, myelodysplastic syndrome, multiple myeloma, hereditary hematologic disease such as thalassemia, sickle cell anemia, pure red cell aplasiaknown coagulation disorder, or hypercoagulable condition. 5.Hemorrhagic disorders in all their forms abd active bleeding 6. New York Heart Association Class III or IV congestive heart failure. 7. Serious infection; 8.Any red blood cell transfusion was performed 2 weeks before the start of treatment 9.Patients who are known to be allergic to the active ingredient or excipient of enarodustat or roxadustat;

Design outcomes

Primary

MeasureTime frame
Changes in hemoglobin from baseline to 7-9 week;

Secondary

MeasureTime frame
Percentage of hemoglobin > 100 g/L;haemoglobin;hypersensitive C-reactive protein;albumin;Thyroid function;Blood pressure;

Countries

China

Contacts

Public ContactWan Qijun

Shenzhen Second People's Hospital, the First Affiliated Hospital of Shenzhen University

yiyuan2224@sina.com+86 135 3785 7368

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026