Last updated: August 23, 2023
Sponsor: Zhongnan Hospital
Overall Status: Active - Recruiting
Phase
3
Condition
Hematologic Neoplasms
Chronic Renal Anemia
Anemic Cancer
Treatment
Shengxuening Tablet
Ferrous succinate
Clinical Study ID
NCT05784870
06
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age>18 years old, gender is not limited;
- Patients diagnosed with blood cancer complicated with anemia;
- During the screening period of ≤1 week, hemoglobin (Hb): 60g/L<Hb≤100g/L;
- Willingness to treat
Exclusion
Exclusion Criteria:
- During the screening period of ≤1 week, hemoglobin (Hb)≤60g/L
- History of blood transfusion within 1 month;
- Urgent blood transfusion or EPO infusion is required within the screening period of ≤1week;
- Folic acid or vitamin B12 deficiency;
- History of iron allergy, history of allergy or intolerance to the study drug;
- Pregnant and lactating women;
- Age <18 years old and body weight ≤35kg;
- Participated in other clinical drug research in the past 3 months;
- Severe cardiac insufficiency (NYHA grade III or above);
- Severe abnormal liver function (ALT, AST and TBIL ≥ 2 times the upper limit of normalvalue);
- Severe renal insufficiency (creatinine clearance ≤ 15ml/min);
- Severe mental disorder;
- Acute and chronic blood loss;
- Combined with a second tumor;
- Ferritin>500μg/L;
- Combined with active tuberculosis;
- Failure to cooperate with treatment according to doctor's advice.
Study Design
Total Participants: 168
Treatment Group(s): 2
Primary Treatment: Shengxuening Tablet
Phase: 3
Study Start date:
February 07, 2023
Estimated Completion Date:
December 31, 2024
Connect with a study center
Zhongnan Hospital of Wuhan University
Wuhan, Hubei 430071
ChinaActive - Recruiting

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