Efficacy and Safety Study of Aspirin for the Prevention of Renal Artery Stenosis in Renal Transplantation Recipients

Study Overview
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Brief Summary
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The anastomotic and peripheral stenosis of the transplanted kidney artery is one of the most important causes of graft failure in renal transplantation. The injury of vascular intima and the formation of microthrombosis may play a significant role in the stenosis of transplanted renal artery of recipients. Inhibiting this process with aspirin may protects against the stenosis of transplanted renal artery. This is a prospective, randomized, controlled, clinical trial to investigate the efficacy and safety of prevention of renal artery stenosis in recipients.

Official Title
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Efficacy and Safety Study of Aspirin for the Prevention of Renal Artery Stenosis in Renal Transplantation Recipients

Conditions
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Renal Transplant

Intervention / Treatment
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* Drug: Aspirin 100mg
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients with the first renal transplantation were stable; Age ≥ 18 years old; Other anticoagulants and non steroidal anti-inflammatory drugs were not taken at the same time; In the past 3 months, there was no acute cardiovascular and cerebrovascular disease or infection; The rejection of acute and chronic renal transplantation was excluded; The thrombus formation of transplanted kidney was excluded. Exclusion Criteria: Allergic or intolerable to aspirin; Previous transplant history; Age < 18; Take other anticoagulants or non steroidal anti-inflammatory drugs at the same time; History of active gastrointestinal bleeding or severe peptic ulcer; Patients with bleeding tendency or severe liver disease; Cerebral hemorrhage, cerebral infarction or acute infection occurred within 3 months; Acute and chronic rejection; Thrombus formation of transplanted renal vessels; Any condition that increases the risk of adverse events or discontinuation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aspirin<br> | Drug: Aspirin 100mg<br>* Daily active drug administered orally for 3 months.<br>|
| Placebo Comparator: Placebo (sugar pill)<br> | Other: Placebo<br>* Sugar pill administered orally for 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Renal Artery Stenosis | Renal artery stenosis is defined as the presence of post-transplant renal artery stenosis in recipients evaluated by ultrasonography or renal arteriography. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Allograft Function | Renal allograft function is evaluated by mean estimated glomerular filtration rate(eGFR). | 2 years | 
| Incidence of Graft Loss | The incidence of kidney failure within 2 years of transplant. | 2 years |