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A controlled clinical trial of the efficacy and safety of sacubitril/valsartan in reducing urinary protein in patients with low-risk membranous nephropathy

A controlled clinical trial of the efficacy and safety of sacubitril/valsartan in reducing urinary protein in patients with low-risk membranous nephropathy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050967
Enrollment
Unknown
Registered
2021-09-08
Start date
2021-09-30
Completion date
Unknown
Last updated
2022-05-16

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

Conditions

membranous nephropathy

Interventions

Experimental group:Conventional therapy+sacubitril/valsartan 100mg bid
Control group:Conventional therapy+valsartan 160mg qd

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The pathological diagnosis of renal biopsy is membranous nephropathy, and secondary membranous nephropathy such as hepatitis B virus-related nephritis, lupus nephritis, tumor-related membranous nephropathy, drug- or poison-related membranous nephropathy is excluded; 2. The patient's 24-hour urine protein quantification is 0.5g-4g/d, and serum ALB>30g/L; 3. eGFR >=75ml/(min*1.73m^2); 4. Aged 30-75 years; 5. Have not received glucocorticoids or immunosuppressants, or biological agents such as rituximab before; 6. Voluntarily join the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Combined with renal artery stenosis; 2. Pregnant or breastfeeding patients; 3. Angioedema has occurred after taking RAS inhibitors; 4. History of malignant tumor or chronic infectious disease; 5. Abnormal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds 2 times the upper limit of normal; 6. ACS or cerebral infarction occurred within 3 months; 7. Severe cognitive impairment or dementia.

Design outcomes

Primary

MeasureTime frame
24 hours urine protein;

Secondary

MeasureTime frame
serum creatinine;serum albumin;estimated glomerular filtration rate;plasma atrial diuretic peptide;24-hour urinary cyclic guanosine monophosphate;blood pressure;

Countries

China

Contacts

Public ContactLi Wen'ge

China-Japan Friendship Hospital

wenge_lee2002@126.com+86 10 84205346

Outcome results

None listed

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