Effectiveness and Safety of Danshen Injection for Acute Kidney Injury in Primary Nephrotic Syndrome
NCT ID: NCT06071533
Last Updated: 2023-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
441 participants
OBSERVATIONAL
2012-01-01
2023-10-03
Brief Summary
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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.
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Detailed Description
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Methods:
This study will be a retrospective cohort study of PNS with AKI patients. Renal function recovery and adverse events of the patients receiving Danshen injection(DS group) will be compared with that of the patients with supportive care(SC group) .The study will be conducted using Hospital Information System of the First Affiliated Hospital of Wenzhou Medical University which has longitudinal health information on over 6 million predominantly privately insured individuals and includes over 50 million followup records. The data of inpatients diagnosed with nephrotic syndrome will be reviewed retrospectively. Patients' information includes socio-demographic characteristics, administrative claims (diagnosis and procedure codes), medical histories, laboratory test results and pharmacy claims. PNS wih AKI inpatients will be enrolled. The baseline characteristics will be propensity-score matched. The outcomes are complete and partial renal function recovery for effectiveness analysis and severe bleeding events for safety analysis. Comparisons of cumulative recovery rate will be performed by Kaplan-Meier curves and log-rank test. Risks for outcomes will be assessed using Cox proportional hazard regression models.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Danshen Injection(DS group)
patients received Danshen Injection
Dandshen
Dandshen injection 20ml /day
Sportive Care group (SC group)
patients received sportive care without Danshen Injection
No interventions assigned to this group
Interventions
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Dandshen
Dandshen injection 20ml /day
Eligibility Criteria
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Inclusion Criteria
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
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 .
20 Years
80 Years
ALL
No
Sponsors
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First Affiliated Hospital of Wenzhou Medical University
OTHER
Responsible Party
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Tianxin Chen
associate chief physician
Locations
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The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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References
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Chen T, Zhou Y, Chen X, Chen B, Pan J. Acute kidney injury in idiopathic membranous nephropathy with nephrotic syndrome. Ren Fail. 2021 Dec;43(1):1004-1011. doi: 10.1080/0886022X.2021.1942913.
Lu H, Xiao L, Song M, Liu X, Wang F. Acute kidney injury in patients with primary nephrotic syndrome: influencing factors and coping strategies. BMC Nephrol. 2022 Mar 5;23(1):90. doi: 10.1186/s12882-022-02720-y.
Chen T, Lv Y, Lin F, Zhu J. Acute kidney injury in adult idiopathic nephrotic syndrome. Ren Fail. 2011;33(2):144-9. doi: 10.3109/0886022X.2011.553301.
Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021 Oct;100(4S):S1-S276. doi: 10.1016/j.kint.2021.05.021. No abstract available.
Lian F, Wu L, Tian J, Jin M, Zhou S, Zhao M, Wei L, Zheng Y, Wang Y, Zhang M, Qin W, Wu Z, Yuan CS, Tong X. The effectiveness and safety of a danshen-containing Chinese herbal medicine for diabetic retinopathy: a randomized, double-blind, placebo-controlled multicenter clinical trial. J Ethnopharmacol. 2015 Apr 22;164:71-7. doi: 10.1016/j.jep.2015.01.048. Epub 2015 Feb 7.
Lyu J, Xue M, Li J, Lyu W, Wen Z, Yao P, Li J, Zhang Y, Gong Y, Xie Y, Chen K, Wang L, Chai Y. Clinical effectiveness and safety of salvia miltiorrhiza depside salt combined with aspirin in patients with stable angina pectoris: A multicenter, pragmatic, randomized controlled trial. Phytomedicine. 2021 Jan;81:153419. doi: 10.1016/j.phymed.2020.153419. Epub 2020 Dec 10.
Zhang Y, Xie Y, Liao X, Jia Q, Chai Y. A Chinese patent medicine Salvia miltiorrhiza depside salts for infusion combined with conventional treatment for patients with angina pectoris: A systematic review and meta-analysis of randomized controlled trials. Phytomedicine. 2017 Feb 15;25:100-117. doi: 10.1016/j.phymed.2017.01.002. Epub 2017 Jan 6.
Lameire NH, Levin A, Kellum JA, Cheung M, Jadoul M, Winkelmayer WC, Stevens PE; Conference Participants. Harmonizing acute and chronic kidney disease definition and classification: report of a Kidney Disease: Improving Global Outcomes (KDIGO) Consensus Conference. Kidney Int. 2021 Sep;100(3):516-526. doi: 10.1016/j.kint.2021.06.028. Epub 2021 Jul 9.
Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.
Menon S. Acute Kidney Injury in Nephrotic Syndrome. Front Pediatr. 2019 Jan 14;6:428. doi: 10.3389/fped.2018.00428. eCollection 2018.
Other Identifiers
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KY2023-R157
Identifier Type: -
Identifier Source: org_study_id
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