Renal TransplantPhase 4NCT04260828
Efficacy and Safety Study of Aspirin for the Prevention of Renal Artery Stenosis in Renal Transplantation Recipients
A Phase 4 study testing Aspirin 100mg in people with Renal Transplant, run by Henan Provincial People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant
- What is being tested?
- Aspirin 100mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 368 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2020to Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000
Xiangyong Tian, +86-15333818352, tianxiangyong888@163.com
About this study
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.
- Conditions
- Renal Transplant
- Being tested
- Aspirin 100mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 100mgDrug
Daily active drug administered orally for 3 months.
PlaceboOther
Sugar pill administered orally for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Active comparator | Not described Receives: Drug: Aspirin 100mg |
| Placebo (sugar pill) | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
Renal Allograft Function
Renal allograft function is evaluated by mean estimated glomerular filtration rate(eGFR).
Measured: 2 years
Incidence of Graft Loss
The incidence of kidney failure within 2 years of transplant.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start28 Feb 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260828
- Sponsor's protocol ID
- 202102310438
- Status last verified
- Jul 2020
- First submitted
- 5 Feb 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36914946
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Aspirin for the Prevention of Renal Artery Stenosis in Renal Transplantation Recipients
- ClinicalTrials.gov ID
- NCT04260828
- Acronym / sponsor ID
- 202102310438
- Conditions
- Renal Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Active comparator | Drug: Aspirin 100mg |
| Placebo (sugar pill) | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 100mgDaily active drug administered orally for 3 months. | Drug | Aspirin |
| PlaceboSugar pill administered orally for 3 months. | Other | Placebo (sugar pill) |
Primary outcome
Incidence of Renal Artery Stenosis
Time frame: 2 years
Renal artery stenosis is defined as the presence of post-transplant renal artery stenosis in recipients evaluated by ultrasonography or renal arteriography.
2 secondary outcomes
Renal Allograft Function
Time frame: 2 years
Incidence of Graft Loss
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Derived from this study: PubMed 36914946Tian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin 100mg in people with Renal Transplant, run by Henan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangyong Tian (+86-15333818352, tianxiangyong888@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Renal Artery Stenosis (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04260828, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.