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

Phase 4

• Conditions: Renal Transplant
• Interventions: Other: Placebo; Drug: Aspirin 100mg

• Registration Number: NCT04260828
• Lead Sponsor: Henan Provincial People's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-07
• Study Start: 2020-02-28
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-29
• Primary Completion: 2021-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 368

Inclusion Criteria

1. The patients with the first renal transplantation were stable;
2. Age ≥ 18 years old;
3. Other anticoagulants and non steroidal anti-inflammatory drugs were not taken at the same time;
4. In the past 3 months, there was no acute cardiovascular and cerebrovascular disease or infection;
5. The rejection of acute and chronic renal transplantation was excluded;
6. The thrombus formation of transplanted kidney was excluded.

Exclusion Criteria

1. Allergic or intolerable to aspirin;
2. Previous transplant history;
3. Age < 18;
4. Take other anticoagulants or non steroidal anti-inflammatory drugs at the same time;
5. History of active gastrointestinal bleeding or severe peptic ulcer;
6. Patients with bleeding tendency or severe liver disease;
7. Cerebral hemorrhage, cerebral infarction or acute infection occurred within 3 months;
8. Acute and chronic rejection;
9. Thrombus formation of transplanted renal vessels;
10. Any condition that increases the risk of adverse events or discontinuation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (sugar pill)	Placebo	-
Aspirin	Aspirin 100mg	-

Primary Outcome Measures

Name	Time	Method
Incidence of Renal Artery Stenosis	2 years	Renal artery stenosis is defined as the presence of post-transplant renal artery stenosis in recipients evaluated by ultrasonography or renal arteriography.

Secondary Outcome Measures

Name	Time	Method
Renal Allograft Function	2 years	Renal allograft function is evaluated by mean estimated glomerular filtration rate(eGFR).
Incidence of Graft Loss	2 years	The incidence of kidney failure within 2 years of transplant.

Trial Locations

Locations (1)

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China