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

NCT04225338 | Completed

• 1 other identifier: FUSaoPaulo TRAS
• Study Type: observational
• Target: 313
• Locations: 1 country
• Sites: 2

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.

Conditions

Transplant Renal Artery Stenosis

Keywords

renal transplantation; transplated renal artery stenosis; percutaneous intervention

Outcome Measures

Primary Outcomes (2)

• overall mortality rate

  overall mortality rate at the end of follow-up

  08 years

• graft failure rate

  graft failure rate at the end of follow-up

  08 years

Secondary Outcomes (2)

• systolic and diastolic pressure measurement in mmHg

  01 month and 01 year

• glomerular filtration rate in mL/min/1,73 m2

  01 month and 01 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Adriano Henrique Pereira Barbosa: lead

Study Sites (2)

Adriano H. P. Barbosa

São Paulo, São Paulo, 04026001, Brazil

Location

Solange Regina Generozo

São Paulo, São Paulo, 04026001, Brazil

Location

Related Publications (18)

• Patel NH, Jindal RM, Wilkin T, Rose S, Johnson MS, Shah H, Namyslowski J, Moresco KP, Trerotola SO. Renal arterial stenosis in renal allografts: retrospective study of predisposing factors and outcome after percutaneous transluminal angioplasty. Radiology. 2001 Jun;219(3):663-7. doi: 10.1148/radiology.219.3.r01jn30663.

  PMID: 11376251 RESULT

• Henning BF, Kuchlbauer S, Boger CA, Obed A, Farkas S, Zulke C, Scherer MN, Walberer A, Banas M, Kruger B, Schlitt HJ, Banas B, Kramer BK. Percutaneous transluminal angioplasty as first-line treatment of transplant renal artery stenosis. Clin Nephrol. 2009 May;71(5):543-9.

  PMID: 19473615 RESULT

• Ngo AT, Markar SR, De Lijster MS, Duncan N, Taube D, Hamady MS. A Systematic Review of Outcomes Following Percutaneous Transluminal Angioplasty and Stenting in the Treatment of Transplant Renal Artery Stenosis. Cardiovasc Intervent Radiol. 2015 Dec;38(6):1573-88. doi: 10.1007/s00270-015-1134-z. Epub 2015 Jun 19.

  PMID: 26088719 RESULT

• Valpreda S, Messina M, Rabbia C. Stenting of transplant renal artery stenosis: outcome in a single center study. J Cardiovasc Surg (Torino). 2008 Oct;49(5):565-70.

  PMID: 18670375 RESULT

• Marini M, Fernandez-Rivera C, Cao I, Gulias D, Alonso A, Lopez-Muniz A, Gomez-Martinez P. Treatment of transplant renal artery stenosis by percutaneous transluminal angioplasty and/or stenting: study in 63 patients in a single institution. Transplant Proc. 2011 Jul-Aug;43(6):2205-7. doi: 10.1016/j.transproceed.2011.06.049.

  PMID: 21839234 RESULT

• Peregrin JH, Stribrna J, Lacha J, Skibova J. Long-term follow-up of renal transplant patients with renal artery stenosis treated by percutaneous angioplasty. Eur J Radiol. 2008 Jun;66(3):512-8. doi: 10.1016/j.ejrad.2007.05.029. Epub 2007 Jul 12.

  PMID: 17629433 RESULT

• Su CH, Lian JD, Chang HR, Wu SW, Chen SC, Tsai CF, Kao PF, Ueng KC. Long-term outcomes of patients treated with primary stenting for transplant renal artery stenosis: a 10-year case cohort study. World J Surg. 2012 Jan;36(1):222-8. doi: 10.1007/s00268-011-1312-3.

  PMID: 22045446 RESULT

• Ali A, Mishler D, Taber T, Agarwal D, Yaqub M, Mujtaba M, Goggins W, Sharfuddin A. Long-term outcomes of transplant recipients referred for angiography for suspected transplant renal artery stenosis. Clin Transplant. 2015 Sep;29(9):747-55. doi: 10.1111/ctr.12574. Epub 2015 Jul 14.

  PMID: 26052624 RESULT

• Hurst FP, Abbott KC, Neff RT, Elster EA, Falta EM, Lentine KL, Agodoa LY, Jindal RM. Incidence, predictors and outcomes of transplant renal artery stenosis after kidney transplantation: analysis of USRDS. Am J Nephrol. 2009;30(5):459-67. doi: 10.1159/000242431. Epub 2009 Sep 24.

  PMID: 19776559 RESULT

• Sharma S, Potdar A, Kulkarni A. Percutaneous transluminal renal stenting for transplant renal artery stenosis. Catheter Cardiovasc Interv. 2011 Feb 1;77(2):287-93. doi: 10.1002/ccd.22758.

  PMID: 20824760 RESULT

• Willicombe M, Sandhu B, Brookes P, Gedroyc W, Hakim N, Hamady M, Hill P, McLean AG, Moser S, Papalois V, Tait P, Wilcock M, Taube D. Postanastomotic transplant renal artery stenosis: association with de novo class II donor-specific antibodies. Am J Transplant. 2014 Jan;14(1):133-43. doi: 10.1111/ajt.12531.

  PMID: 24354873 RESULT

• Audard V, Matignon M, Hemery F, Snanoudj R, Desgranges P, Anglade MC, Kobeiter H, Durrbach A, Charpentier B, Lang P, Grimbert P. Risk factors and long-term outcome of transplant renal artery stenosis in adult recipients after treatment by percutaneous transluminal angioplasty. Am J Transplant. 2006 Jan;6(1):95-9. doi: 10.1111/j.1600-6143.2005.01136.x.

  PMID: 16433762 RESULT

• Seratnahaei A, Shah A, Bodiwala K, Mukherjee D. Management of transplant renal artery stenosis. Angiology. 2011 Apr;62(3):219-24. doi: 10.1177/0003319710377076. Epub 2010 Aug 3.

  PMID: 20682611 RESULT

• Voiculescu A, Schmitz M, Hollenbeck M, Braasch S, Luther B, Sandmann W, Jung G, Modder U, Grabensee B. Management of arterial stenosis affecting kidney graft perfusion: a single-centre study in 53 patients. Am J Transplant. 2005 Jul;5(7):1731-8. doi: 10.1111/j.1600-6143.2005.00927.x.

  PMID: 15943633 RESULT

• Ghirardo G, De Franceschi M, Vidal E, Vidoni A, Ramondo G, Benetti E, Motta R, Ferraro A, Zanon GF, Miotto D, Murer L. Transplant renal artery stenosis in children: risk factors and outcome after endovascular treatment. Pediatr Nephrol. 2014 Mar;29(3):461-7. doi: 10.1007/s00467-013-2681-7. Epub 2013 Dec 5.

  PMID: 24305958 RESULT

• Bruno S, Remuzzi G, Ruggenenti P. Transplant renal artery stenosis. J Am Soc Nephrol. 2004 Jan;15(1):134-41. doi: 10.1097/01.asn.0000099379.61001.f8.

  PMID: 14694165 RESULT

• Faccinetto ACB, Santos GRF, Taguchi JC, Orellana HC, Galhardo A, Kanhouche G, Barteczko MLM, Tedesco Junior H, Bravo-Valenzuela NJM, Moises VA, Pestana JOM, Silva CMC, Barbosa AHP. Retrospective analysis of percutaneous intervention of the renal artery in transplanted kidneys in children and adolescents at a tertiary public hospital. PLoS One. 2024 Mar 29;19(3):e0297975. doi: 10.1371/journal.pone.0297975. eCollection 2024.

  PMID: 38551934 DERIVED

• Kanhouche G, Santos GRF, Orellana HC, Galhardo A, Faccinetto ACB, Barteczko MLM, de Carvalho LSF, Taddeo JB, Foresto RD, Moises VA, Tedesco-Silva H, Pestana JM, Barbosa AHP. Risk factors of transplant renal artery stenosis in kidney transplant recipients. Clinics (Sao Paulo). 2022 Aug 2;77:100087. doi: 10.1016/j.clinsp.2022.100087. eCollection 2022.

  PMID: 35931001 DERIVED

Study Officials

• Adriano HP Barbosa, MDPhD

  Unifesp/EPM

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 13, 2020
• Study Start: January 2, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)