Chronic Kidney Disease
Conditions
Keywords
chronic kidney disease, hypertension
Brief summary
The purpose of this study is to ascertain whether Arotinolol Hydrochloride reduces mortality and cardiovascular events in chronic kidney disease stage 5 patients with hypertension.
Interventions
Antihypertensive medications plus arotinolol hydrochloride, dosage of arotinolol hydrochloride from 2.5mg bid, 2 days later increased to 5mg bid or 10mg bid, for 18 months
DRUGNon arotinolol group
Antihypertensive medications without arotinolol for 18 months
Sponsors
Sumitomo Pharma (Suzhou) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 18-75 years-old; * Chronic kidney disease stage 5 with haemodialysis treatment for 2 months; * Patients with blood pressure≥140/90 mmHg after receiving 2 or 3 antihypertensive medications for 2 weeks; * Patients who receiving alfa or beta blockers will be washed out for 2 weeks; * Written informed consent
Exclusion criteria
* Unstable angina, myocardial infarction, symptomatic or continuous arrhythmia, cardiosurgery in the last 2 months; * Patients who taking class I antiarrhythmic drugs; * Resting heart rate less than 60; * Patients with systolic pressure less than 90 mmHg; * Patients with chronic obstructive pulmonary disease and asthma; * Patients with cerebral infarction in the last 2 weeks; * Severe disorders of liver function; * Allergy to the arotinolol; * Patients who planning to have kidney transplantation in the near future; * Pregnancy and breast-feeding; * Malignant tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoints | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Changes for metabolism related index | 18 months |
| Blood pressure control in hypertensive haemodialysis patients | 18 months |
Countries
China
Outcome results
None listed