Back to resultsEfficacy and Safety Study of Aspirin for the Prevention of Renal Artery Stenosis in Renal Transplantation Recipients
Primary Purpose
Renal Transplant
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Aspirin 100mg
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Renal Transplant
Eligibility Criteria
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.
Sites / Locations
- Henan Provincial People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Aspirin
Placebo (sugar pill)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Renal Allograft Function
Renal allograft function is evaluated by mean estimated glomerular filtration rate(eGFR).
Incidence of Graft Loss
The incidence of kidney failure within 2 years of transplant.
Full Information
NCT ID
NCT04260828
First Posted
February 5, 2020
Last Updated
July 27, 2020
Sponsor
Henan Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04260828
Brief Title
Efficacy and Safety Study of Aspirin for the Prevention of Renal Artery Stenosis in Renal Transplantation Recipients
Official Title
Efficacy and Safety Study of Aspirin for the Prevention of Renal Artery Stenosis in Renal Transplantation Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Provincial People's Hospital
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Transplant
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
368 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aspirin
Arm Type
Active Comparator
Arm Title
Placebo (sugar pill)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Aspirin 100mg
Intervention Description
Daily active drug administered orally for 3 months.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Sugar pill administered orally for 3 months.
Primary Outcome Measure Information:
Title
Incidence of Renal Artery Stenosis
Description
Renal artery stenosis is defined as the presence of post-transplant renal artery stenosis in recipients evaluated by ultrasonography or renal arteriography.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Renal Allograft Function
Description
Renal allograft function is evaluated by mean estimated glomerular filtration rate(eGFR).
Time Frame
2 years
Title
Incidence of Graft Loss
Description
The incidence of kidney failure within 2 years of transplant.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangyong Tian
Phone
+86-15333818352
Email
tianxiangyong888@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tianzhong Yan
Phone
+86-13663718703
Email
ytz460@hotmail.com
Facility Information:
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangyong Tian
Phone
+86-15333818352
Email
tianxiangyong888@163.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Aspirin for the Prevention of Renal Artery Stenosis in Renal Transplantation Recipients
We'll reach out to this number within 24 hrs