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

Zhengzhou University

Status and phase: Unknown; Phase 4

Conditions: Renal Transplant

Treatments: Other: Placebo; Drug: Aspirin 100mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04260828

202102310438

Details and patient eligibility

About

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.

Enrollment: 368 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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368 participants in 2 patient groups, including a placebo group

Aspirin

Active Comparator group

Treatment:

Drug: Aspirin 100mg

Placebo (sugar pill)

Placebo Comparator group

Treatment:

Other: Placebo