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

Renal Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04260828
• Other study ID #: 202102310438
• Status: Recruiting
• Phase: Phase 4
• Start date: February 28, 2020
• Est. completion date: December 2022

Study information

• Verified date: July 2020
• Source: Henan Provincial People's Hospital
• Contact: Xiangyong Tian
• Phone: +86-15333818352
• Email: tianxiangyong888[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 368
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Renal Artery Obstruction
• Renal Transplant

Intervention

Drug:
• Aspirin 100mg
Daily active drug administered orally for 3 months.

Other:
• Placebo
Sugar pill administered orally for 3 months.

Locations

Country	Name	City	State
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Renal Allograft Function	Renal allograft function is evaluated by mean estimated glomerular filtration rate(eGFR).	2 years
Secondary	Incidence of Graft Loss	The incidence of kidney failure within 2 years of transplant.	2 years