An interventional study of Roxadustat;Sacubitril Valsartan Sodium Tablets; and EPO; ACEI / ARB in Cardio-Renal Syndrome, sponsored by The Affiliated Hospital of Qingdao University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-09-23.
Sponsored by The Affiliated Hospital of Qingdao University · Not applicable, Interventional, and Treatment
A randomized and parallel controlled trial design of comparing the new treatment group of Roxadustat combined with Sacubitril Valsartan Sodium Tablets with the traditional treatment group of recombinant human erythropoietin (EPO) combined with ACEI or ARB in Chinese patients with cardiorenal anemia syndrome.
76 studies on the registry are indexed under Cardio-Renal Syndrome; 22 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 46 interventional studies indexed under Cardio-Renal Syndrome.
Browse Cardio-Renal Syndrome studies →The Affiliated Hospital of Qingdao University is the lead sponsor of 142 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Roxadustat(FibroGen, China), 100mg (45-60kg) or 120mg (≥ 60kg) each time, three times a week, orally on an empty stomach in the morning. The initial dose of Sacubitril Valsartan Sodium Tablets(Novartis, China) is 50mg, once a day, taken on an empty stomach in the morning, and gradually titrated from the minimum dose to the maximum tolerated dose.
Drug: Roxadustat;Sacubitril Valsartan Sodium Tablets;
Recombinant human erythropoietin (SEBOR, 10000 units / Branch) was injected subcutaneously once a week; Perindopril tablets (Servier, China), taken on an empty stomach, gradually titrated from the minimum dose to the maximum tolerated dose.
Drug: EPO; ACEI / ARB
Select the appropriate dose according to the patient's situation
Also known as: Entresto®
Select the appropriate ACEI /ARB according to the subject's situation or follow its previous medication
Changes of hemoglobin level before and after treatment
By detecting blood routine,calculate the changes of hemoglobin.Change value of hemoglobin level(g/L) = baseline hemoglobin level(g/L) - hemoglobin level after treatment(g/L)
Time frame: Day0-Day90
Changes of ejection fraction before and after treatment
Cardiac ejection fraction was measured by cardiac ultrasound before and after treatment，and change of cardiac ejection fraction(%) = baseline cardiac ejection fraction level(%) - post-treatment cardiac ejection fraction level(%)
Time frame: Day0-Day90
Incidence of acute heart failure, acute myocardial infarction, severe hyperkalemia and severe anemia during treatment
Incidence rate = number of patients with the events/ total number of patients included in the study in this group.
Time frame: Day0-Day90
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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The Affiliated Hospital of Qingdao University