NCT04260828

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
368

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

February 28, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

1.8 years

First QC Date

February 5, 2020

Last Update Submit

July 27, 2020

Conditions

Renal Transplant

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Renal Allograft Function

    2 years

  • Incidence of Graft Loss

    2 years

Study Arms (2)

Aspirin

ACTIVE COMPARATOR
Drug: Aspirin 100mg

Placebo (sugar pill)

PLACEBO COMPARATOR
Other: Placebo

Interventions

Aspirin 100mgDRUG

Daily active drug administered orally for 3 months.

Aspirin
PlaceboOTHER

Sugar pill administered orally for 3 months.

Placebo (sugar pill)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

Related Publications (1)

  • Tian X, Ji B, Niu X, Duan W, Wu X, Cao G, Zhang C, Zhao J, Wang Z, Gu Y, Cao H, Qin T, Shao F, Yan T. Efficacy and safety of low-dose aspirin on preventing transplant renal artery stenosis: a prospective randomized controlled trial. Chin Med J (Engl). 2023 Mar 5;136(5):541-549. doi: 10.1097/CM9.0000000000002574.

    PMID: 36914946DERIVED

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Central Study Contacts

Xiangyong Tian

CONTACT

+86-15333818352tianxiangyong888@163.com

Tianzhong Yan

CONTACT

+86-13663718703ytz460@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 7, 2020

Study Start

February 28, 2020

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

July 29, 2020

Record last verified: 2020-07

Locations

CN(1)