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Retrospective Study of Patients Undergoing Percutaneous Intervention of the Transplant Renal Artery Stenosis (TRAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04225338
Recruitment Status : Completed
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Adriano Henrique Pereira Barbosa, Federal University of São Paulo

Brief Summary:

Renal transplantation is the standard treatment for patients with end-stage chronic kidney disease because it is effective in reducing the morbidity and mortality. Despite of the satisfactory results, some patients evolve with graft dysfunction and refractory hypertension due to transplanted renal artery stenosis (TRAS). TRAS is the main vascular complication of patients undergoing kidney transplantation, with a reported incidence ranging 1 to 23% in the different series in the literature, depending on the definition and diagnostic techniques used, manifesting most commonly between the 3rd month and the 2nd year after transplantation.

Percutaneous intervention of TRAS is widely accepted as a viable treatment option, but there are few long-term data on patients undergoing angioplasty. The aim of this study was to evaluate long term outcomes clinical in patients with TRAS underwent to percutaneous intervention with or without stent.


Condition or disease
Transplant Renal Artery Stenosis

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 313 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Study of Patients Undergoing Percutaneous Intervention of the Transplant Renal Artery Stenosis (TRAS Study)
Actual Study Start Date : January 2, 2016
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 1, 2019



Primary Outcome Measures :
  1. overall mortality rate [ Time Frame: 08 years ]
    overall mortality rate at the end of follow-up

  2. graft failure rate [ Time Frame: 08 years ]
    graft failure rate at the end of follow-up


Secondary Outcome Measures :
  1. systolic and diastolic pressure measurement in mmHg [ Time Frame: 01 month and 01 year ]
    systolic and diastolic pressure measurement in mmHg at 01 month and 01 year

  2. glomerular filtration rate in mL/min/1,73 m2 [ Time Frame: 01 month and 01 year ]
    glomerular rate at 01 month and 01 year in mL/min/1,73 m2



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with suspected transplanted renal artery stenosis and referred to the hemodynamics laboratory for angiography of the transplanted renal artery.
Criteria

Inclusion Criteria:

  • patients with clinical suspicion of transplanted renal artery stenosis.
  • patients undergoing angiography of the transplanted renal artery.
  • patients undergoing transplanted renal artery stenosis intervention with and without stent.

Exclusion Criteria:

  • refuses to participate in the study.
  • patients without clinical follow-up.
  • patients who did not renal transplanted at the hospital do Rim.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04225338


Locations
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Brazil
Adriano H. P. Barbosa
São Paulo, SP, Brazil, 04026001
Solange Regina Generozo
São Paulo, SP, Brazil, 04026001
Sponsors and Collaborators
Adriano Henrique Pereira Barbosa
Investigators
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Study Chair: Adriano HP Barbosa, MDPhD Unifesp/EPM
Publications of Results:

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Responsible Party: Adriano Henrique Pereira Barbosa, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT04225338    
Other Study ID Numbers: FUSaoPaulo TRAS
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Adriano Henrique Pereira Barbosa, Federal University of São Paulo:
renal transplantation
transplated renal artery stenosis
percutaneous intervention
Additional relevant MeSH terms:
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Renal Artery Obstruction
Constriction, Pathologic
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases