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

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.

Study Overview

• Status: Unknown
• Conditions: Renal Transplant
• Intervention / Treatment: Drug: Aspirin 100mg; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 368
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiangyong Tian; Phone Number: +86-15333818352; Email: tianxiangyong888@163.com
• Study Contact Backup: Name: Tianzhong Yan; Phone Number: +86-13663718703; Email: ytz460@hotmail.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Henan Provincial People's Hospital
      • Contact: Xiangyong Tian; Phone Number: +86-15333818352; Email: tianxiangyong888@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Henan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Kidney Diseases; Urologic Diseases; Renal Artery Obstruction; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: 202102310438

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes