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A multicenter randomized controlled trial to evaluate the efficacy and safety of sacubitril/valsartan in CKD 3b-5 non-dialysis patients with mild to moderate hypertension

A multicenter randomized controlled trial to evaluate the efficacy and safety of sacubitril/valsartan in CKD 3b-5 non-dialysis patients with mild to moderate hypertension

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050673
Enrollment
Unknown
Registered
2021-09-01
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

Chronic kidney disease

Interventions

Experimental group:Sacubitril valsartan + conventional antihypertensive
Control group:Conventional blood pressure reduction program

Sponsors

The Third Affiliated Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily sign the informed consent; 2. Aged 18 to 80 years; 3. CKD stage 3b-5 non-dialysis patients with a clear diagnosis, i.e. patients with chronic kidney disease without dialysis whose eGFR was calculated according to the 2009 CKD-EPI 1000ml; 5. 24-hour urine protein quantification 30g/L; 6. The patient has mild to moderate essential hypertension (msSBP >= 140 mmHg and < 180 mmHg), untreated or currently receiving antihypertensive therapy.

Exclusion criteria

Exclusion criteria: 1. Females of childbearing potential who are not contraceptive, pregnant or breastfeeding; 2. Severe hypertension (msDBP >= 110 mmHg and/or msSBP >= 180 mmHg); 3. Patients treated with hormones or immunosuppressants in the past 3 months; 4. Angioedema has occurred, caused by drug-related or other reasons reported by patients; 5. History or evidence of secondary hypertension, including but not limited to the following: renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary aldosteronism, Cushing disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension; 6. Patients currently diagnosed with acute heart failure or hemodynamic instability; 7. Heart valve disease with significant clinical significance; 8. Past or current heart disease of the following: second or third degree atrioventricular block without a pacemaker; clinically significant arrhythmia, including uncontrolled atrial fibrillation (ventricular rate >= 120 bpm); Have a family history of long QT syndrome or torsades de pointes; 9. History of malignant tumor of any organ system in the past 5 years, whether there is any evidence of local recurrence or metastasis, with or without treatment, except for localized basal cell skin cancer; 10. Known to have active liver disease or cirrhosis or ALT or AST values ??found at visit 1 were more than 2 times higher than the upper limit of normal (xULN), or TBL > 2 xULN or ALP > 1.5 xULN, or hepatic History of encephalopathy, history of esophageal varices, or history of portal venous shunt; 11. All any surgical or medical conditions that may significantly alter the absorption, distribution, metabolism or excretion of the drug, including but not limited to the following: History of major gastrointestinal surgery, such as gastrectomy, gastrointestinal anastomosis, bowel resection, Gastric bypass surgery, gastric separation, or gastric banding, active inflammatory bowel disease or previous occurrence within 12 months prior to Visit 1, which the investigator considers to be clinically significant; 12. There is a contraindication or a history of allergies to the study drug or drugs with similar chemical structures; 13. Serum potassium > 5.5 mEq/L at visit 1; ALT or AST > 2 times the upper limit of the normal range (ULN); or other clinically significant laboratory abnormalities confirmed by repeated measurements; 14. The investigator believes that any medical or surgical condition that is not specified in the protocol may bring high risk to the patient, or prevent the patient from complying with the study requirements and failing to complete the study.

Design outcomes

Primary

MeasureTime frame
The decrease in epidermal growth factor receptor relative to the baseline value;

Countries

China

Contacts

Public ContactTang Ying

The Third Affiliated Hospital of Southern Medical University

ty.102@163.com+86 13533646831

Outcome results

None listed

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