Status:
COMPLETED
Effectiveness and Safety of Danshen Injection for Acute Kidney Injury in Primary Nephrotic Syndrome
Lead Sponsor:
First Affiliated Hospital of Wenzhou Medical University
Conditions:
Acute Kidney Injury
Nephrotic Syndrome
Eligibility:
All Genders
20-80 years
Brief Summary
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 prophyla...
Detailed Description
Background and objectives： Acute kidney injury (AKI) is a common complication of primary nephrotic syndrome (PNS), affecting approximately 23.7% to 34% of PNS patients. No randomized clinical trials a...
Eligibility Criteria
Inclusion
- age \>=20yr;
- Patients must have at least one "Evaluation and Management"visit with a diagnosis of PNS 6 months before index date;
- Patients must have AKI at the index date.
Exclusion
- 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；
- Cancer patients；
- Liver cirrhosis；
- Transplant patients;
- Guillain-Barre syndrome；
- Maintain Remission in PNS；
- Chronic renal failure；
- PNS without AKI;
- PNS with autosomal dominant polycystic kidney disease;
- 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 ;
- PNS accompanied with pulmonary embolism, acute cerebrovascular accident,Pregnancy;
- Acute rapid progressive or Crescentic Glomerulonephritis;
- Patients without valid data .
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 3 2023
Estimated Enrollment :
441 Patients enrolled
Trial Details
Trial ID
NCT06071533
Start Date
January 1 2012
End Date
October 3 2023
Last Update
October 10 2023
Active Locations (1)
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1
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000