Effectiveness and Safety of Danshen Injection for Acute Kidney Injury in Primary Nephrotic Syndrome

KY2023-R157

The goal of this real-world observational study is to evaluate the effectiveness and safety of the Chinese herbal-derived therapeutic Danshen injection following immunosuppressive therapy and prophylactic anticoagulation with low molecular heparin for acute kidney injury in primary nephrotic syndrome. The main questions to answer are: Whether or not Danshen injection is beneficial for acute kidney injury patients in primary nephrotic syndrome patients. Whether or not Danshen injection will increase the bleeding risk in primary nephrotic syndrome patients receiving low molecular heparin. Participants' information will be retrieved from hospital files stored in medical records and the electronic patient data registry. Participants received Danshen injection will be compared with control group to evaluate the recovery of renal function and side effects.

2012-01-01

2022-12-30

2023-10-03

Completed

441

Inclusion Criteria: 1. age \>=20yr; 2. Patients must have at least one "Evaluation and Management"visit with a diagnosis of PNS 6 months before index date; 3. Patients must have AKI at the index date. Exclusion Criteria: 1. Secondary necrotic syndrome, which is define as necrotic syndrome caused by diabetic nephropathy, lupus nephritis, castleman syndrome, cryoglobulinemia, lymphoma, systemic vasculitis, hepatitis C associated nephritis, hepatitis B associated nephritis, monoclonal immunoglobulinemia, amyloidosis, Sjogren's disease, myeloma, macroglobulinemia and Henoch-Schonlein purpura nephritis； 2. Cancer patients； 3. Liver cirrhosis； 4. Transplant patients; 5. Guillain-Barre syndrome； 6. Maintain Remission in PNS； 7. Chronic renal failure； 8. PNS without AKI; 9. PNS with autosomal dominant polycystic kidney disease; 10. AKI caused by bleeding, haemolytic uraemic syndrome, malignant hypertension，IgG4 related tubulointerstitial nephritis, infection, acute coronary syndrome or heart failure, obstructive nephropathy and nephrotoxic drug ; 11. PNS accompanied with pulmonary embolism, acute cerebrovascular accident,Pregnancy; 12. Acute rapid progressive or Crescentic Glomerulonephritis; 13. Patients without valid data .

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 441, 'type': 'ACTUAL'}}

2023-10-10