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A multicenter, randomized, controlled trial to evaluate the effects of Roxadustat on left ventricular hypertrophy and cardiac function in hemodialysis patients

A multicenter, randomized, controlled trial to evaluate the effects of Roxadustat on left ventricular hypertrophy and cardiac function in hemodialysis patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041202
Enrollment
Unknown
Registered
2020-12-22
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-03-01

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

Conditions

CKD5

Interventions

Group 2:Erythropoietin

Sponsors

The Third Affiliated Hospital of Chongqing Medical University (Gener Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Aged >= 18 and = 3 months; 3) After the nature of the study was explained and the subjects had the opportunity to ask questions, the subjects voluntarily signed and dated the informed consent form approved by the ethics committee; 4) Patients with renal anemia, including patients who have previously received erythropoietin treatment and patients who can start using the above drugs based on the clinical judgment of the researchers.

Exclusion criteria

Exclusion criteria: 1) Previous history of aortic stenosis, hypertrophic obstructive cardiomyopathy, pericardial tamponade, acute and chronic pericarditis, constrictive pericarditis; 2) Acute coronary syndrome, severe arrhythmia and myocardial infarction occurred in the past 6 months; 3) Any other anemia caused by diseases other than CKD, such as thalassemia, sickle cell anemia, pure red cell aplasia, tumor related anemia, chemotherapy-related anemia, myelodysplastic syndrome, bleeding, malignant tumor, etc; 4) The patients who had been given oral roxestat for 6 months and who are taking salkubaltravalsartan orally; 5) Patients with a history of severe drug allergy or known hypersensitivity to active ingredients or excipients of rosalrestat; 6) Pregnant or lactating women, or women with fertility but unwilling to take contraceptive measures; 7) According to the researcher's judgment, the life expectancy was less than 12 months; 8) In the screening period, the patients with severe liver function abnormality met any of the following criteria: a) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 3 x ULN and total bilirubin >= 2 x ULN; b) ALT or ast > 8 x ULN; c) Total bilirubin >= 5 x ULN; 9) Patients who are participating in or will participate in other intervention studies

Design outcomes

Primary

MeasureTime frame
Left ventricular mass index;Cardiac ejection fraction;

Secondary

MeasureTime frame
Hemoglobin;Iron index;Blood lipids;NT-proBNP;

Countries

China

Contacts

Public ContactYang Jurong

The Third Affiliated Hospital of Chongqing Medical University (Gener Hospital)

yjr923@163.com+86 15802391006

Outcome results

None listed

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