Transplant Renal Artery StenosisTRASNCT04225338
Retrospective Study of Patients Undergoing Percutaneous Intervention of the Transplant Renal Artery Stenosis
An observational study of Transplant Renal Artery Stenosis, run by Adriano Henrique Pereira Barbosa at 2 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transplant Renal Artery Stenosis
- How many people
- 313 participants
- Where
- 2 sitesBrazil
- Study dates
- 2 Jan 2016to 1 Feb 2019
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with suspected transplanted renal artery stenosis and referred to the hemodynamics laboratory for angiography of the transplanted renal artery.
Who may be able to join
- 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.
Who cannot join
- refuses to participate in the study.
- patients without clinical follow-up.
- patients who did not renal transplanted at the hospital do Rim.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Adriano H. P. Barbosa
São Paulo, São Paulo, 04026001
Solange Regina Generozo
São Paulo, São Paulo, 04026001
About this study
Official title: Retrospective Study of Patients Undergoing Percutaneous Intervention of the Transplant Renal Artery Stenosis (TRAS Study)
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.
Read the detailed description
Renal transplantation is the standard treatment for patients with end-stage chronic kidney disease, as it is effective in reducing the morbidity and mortality of patients in this condition. Despite satisfactory results, some patients have graft dysfunction and difficult-to-control hypertension, with the main cause of transplanted renal artery stenosis (TRAS).
The incidence of TRAS varies from 1 to 23% in the various series in the literature, depending on the definition and diagnostic techniques used, most commonly occurring between the 3rd month and the 2nd year after transplantation. However, it may present at any time with refractory hypertension and / or graft dysfunction in the absence of rejection, ureteral obstruction or infection.
About 50% of TRAS cases occur at the anastomosis site and there seems to be no relationship with the type of anastomosis, whether end-to-end or end-to-side. TRAS is generally a consequence of clamp perfusion injury, incorrect suture technique, or fibrotic inflammatory reaction to suture material. Other factors attributed to TRAS are secondary to graft rejection, cytomegalovirus infection, and cadaveric donor graft. The last two factors are controversial in the literature. Late TRAS is related to progressive atherosclerosis.
The diagnosis of TRAS is made by clinical manifestations and / or by complementary exams. In addition to refractory hypertension, patients with TRAS may have increased serum creatinine, sudden graft deterioration and acute pulmonary edema. Color Doppler ultrasonography is the most commonly used method due to its easy access, low cost and does not require the use of contrast or radiolabels. However, its biggest limitation is the heavy reliance on operator expertise. It has a sensitivity of 87 to 94% and a specificity of 86 to 100%. TRAS is suspected when Doppler ultrasound has a peak systolic velocity (PSV) above 180 cm / s and a resistance index <0.50.
Computed tomography provides three-dimensional images that may be superior to those of selective angiography, with the advantage of not requiring arterial puncture and requiring less contrast. Nuclear magnetic resonance is even superior to tomography, with a sensitivity of 67 to 100% and specificity of 75 to 100%. However, its availability is still limited, besides presenting high costs.
Renal arteriography is the gold standard for the diagnosis of TRAS. However, there is a need for high contrast volumes, which can precipitate acute renal failure, particularly in patients who already have renal dysfunction. Three-dimensional rotational angiography (3D-RA) appears as an auxiliary tool that can minimize the deleterious effects of contrast. The measurements obtained by 3D-RA showed a strong correlation with the measurements made by conventional angiography, demonstrating equivalent accuracy, without the need for additional projections, helping to perform the intervention.
Complications arising from transplanted kidney arteriography are puncture site hematomas, pseudoaneurysms, thromboembolism, arteriovenous fistulas, iliac artery dissection, graft artery dissection, occurring in less than 10% of cases. Due to the substantial risks and high costs, arteriography cannot be considered a screening method and is only indicated when a stenosis is suspected based on noninvasive exams.
Percutaneous intervention has been the method of choice for the treatment of TRAS with satisfactory results and few short-term complications, and its efficacy has been demonstrated, especially when using stents, in the various case series published in the literature. However, there is little data on long-term intervention, showing reduced mortality and graft preservation.
Evaluated data from the 2000-2005 United States Renal Data System (USRDS) and found no differences in mortality or renal loss in patients undergoing TRAS angioplasty (145 patients) compared to those who only underwent clinical treatment (678 patients) .
In a recently published systematic review, the authors demonstrated that percutaneous intervention with or without stenting was effective in the treatment of TRAS, with favorable results in terms of technical success (over 90%), clinical success, long graft patency, with few serious complications described. However, the authors report the absence of well-designed robust randomized studies, most of which are retrospective series of a single center with a low casuistic. The positive findings of this review contrast with the results found in the treatment of native renal artery stenosis, where stent revascularization showed no benefit in patients with atherosclerotic renovascular disease when compared to drug treatment. In this same article, the authors describe the inconsistency and lack of standardization in the methodology for defining the outcomes of the intervention on TRAS.
The Hospital do Rim e Hipertensão, an agency linked to the Federal University of São Paulo (Unifesp) in Brazil, is the world leader in renal transplantation, performing an average of 1000 transplants / year in recent years. From 2006 to January 2015, patients with suspected TRAS were referred for angiography in the Hemodynamics of Hospital São Paulo.
The aims of this study was to retrospectively evaluate all patients referred to service with suspected TRAS who underwent angiography and intervention.
- Conditions
- Transplant Renal Artery Stenosis
- Keywords
- renal transplantation, transplated renal artery stenosis, percutaneous intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
overall mortality rate
overall mortality rate at the end of follow-up
Measured: 08 years
graft failure rate
graft failure rate at the end of follow-up
Measured: 08 years
Secondary outcomes (2)
systolic and diastolic pressure measurement in mmHg
systolic and diastolic pressure measurement in mmHg at 01 month and 01 year
Measured: 01 month and 01 year
glomerular filtration rate in mL/min/1,73 m2
glomerular rate at 01 month and 01 year in mL/min/1,73 m2
Measured: 01 month and 01 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start2 Jan 2016
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Transplant Renal Artery StenosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adriano Henrique Pereira Barbosa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adriano Henrique Pereira Barbosa, Federal University of São Paulo
- Investigators
- Adriano HP Barbosa, MDPhD, Study chair, Unifesp/EPM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225338
- Sponsor's protocol ID
- FUSaoPaulo TRAS
- Acronym
- TRAS
- Status last verified
- Jan 2020
- First submitted
- 7 Jan 2020
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 11376251Henning 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.
PubMed 19473615Ngo 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.
PubMed 26088719Valpreda 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.
PubMed 18670375Marini 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.
PubMed 21839234Peregrin 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.
PubMed 17629433Su 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.
PubMed 22045446Ali 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.
PubMed 26052624Hurst 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.
PubMed 19776559Sharma 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.
PubMed 20824760Willicombe 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.
PubMed 24354873Audard 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.
PubMed 16433762Seratnahaei 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.
PubMed 20682611Voiculescu 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.
PubMed 15943633Ghirardo 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.
PubMed 24305958
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Patients Undergoing Percutaneous Intervention of the Transplant Renal Artery Stenosis (TRAS Study)
- ClinicalTrials.gov ID
- NCT04225338
- Acronym / sponsor ID
- TRAS / FUSaoPaulo TRAS
- Conditions
- Transplant Renal Artery Stenosis
- Keywords
- renal transplantation, transplated renal artery stenosis, percutaneous intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Adriano Henrique Pereira BarbosaUniversity, hospital or other
- Study start
- 2 Jan 2016 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 13 Jan 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.
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.
Detailed description
Renal transplantation is the standard treatment for patients with end-stage chronic kidney disease, as it is effective in reducing the morbidity and mortality of patients in this condition. Despite satisfactory results, some patients have graft dysfunction and difficult-to-control hypertension, with the main cause of transplanted renal artery stenosis (TRAS).
The incidence of TRAS varies from 1 to 23% in the various series in the literature, depending on the definition and diagnostic techniques used, most commonly occurring between the 3rd month and the 2nd year after transplantation. However, it may present at any time with refractory hypertension and / or graft dysfunction in the absence of rejection, ureteral obstruction or infection.
About 50% of TRAS cases occur at the anastomosis site and there seems to be no relationship with the type of anastomosis, whether end-to-end or end-to-side. TRAS is generally a consequence of clamp perfusion injury, incorrect suture technique, or fibrotic inflammatory reaction to suture material. Other factors attributed to TRAS are secondary to graft rejection, cytomegalovirus infection, and cadaveric donor graft. The last two factors are controversial in the literature. Late TRAS is related to progressive atherosclerosis.
The diagnosis of TRAS is made by clinical manifestations and / or by complementary exams. In addition to refractory hypertension, patients with TRAS may have increased serum creatinine, sudden graft deterioration and acute pulmonary edema. Color Doppler ultrasonography is the most commonly used method due to its easy access, low cost and does not require the use of contrast or radiolabels. However, its biggest limitation is the heavy reliance on operator expertise. It has a sensitivity of 87 to 94% and a specificity of 86 to 100%. TRAS is suspected when Doppler ultrasound has a peak systolic velocity (PSV) above 180 cm / s and a resistance index <0.50.
Computed tomography provides three-dimensional images that may be superior to those of selective angiography, with the advantage of not requiring arterial puncture and requiring less contrast. Nuclear magnetic resonance is even superior to tomography, with a sensitivity of 67 to 100% and specificity of 75 to 100%. However, its availability is still limited, besides presenting high costs.
Renal arteriography is the gold standard for the diagnosis of TRAS. However, there is a need for high contrast volumes, which can precipitate acute renal failure, particularly in patients who already have renal dysfunction. Three-dimensional rotational angiography (3D-RA) appears as an auxiliary tool that can minimize the deleterious effects of contrast. The measurements obtained by 3D-RA showed a strong correlation with the measurements made by conventional angiography, demonstrating equivalent accuracy, without the need for additional projections, helping to perform the intervention.
Complications arising from transplanted kidney arteriography are puncture site hematomas, pseudoaneurysms, thromboembolism, arteriovenous fistulas, iliac artery dissection, graft artery dissection, occurring in less than 10% of cases. Due to the substantial risks and high costs, arteriography cannot be considered a screening method and is only indicated when a stenosis is suspected based on noninvasive exams.
Percutaneous intervention has been the method of choice for the treatment of TRAS with satisfactory results and few short-term complications, and its efficacy has been demonstrated, especially when using stents, in the various case series published in the literature. However, there is little data on long-term intervention, showing reduced mortality and graft preservation.
Evaluated data from the 2000-2005 United States Renal Data System (USRDS) and found no differences in mortality or renal loss in patients undergoing TRAS angioplasty (145 patients) compared to those who only underwent clinical treatment (678 patients) .
In a recently published systematic review, the authors demonstrated that percutaneous intervention with or without stenting was effective in the treatment of TRAS, with favorable results in terms of technical success (over 90%), clinical success, long graft patency, with few serious complications described. However, the authors report the absence of well-designed robust randomized studies, most of which are retrospective series of a single center with a low casuistic. The positive findings of this review contrast with the results found in the treatment of native renal artery stenosis, where stent revascularization showed no benefit in patients with atherosclerotic renovascular disease when compared to drug treatment. In this same article, the authors describe the inconsistency and lack of standardization in the methodology for defining the outcomes of the intervention on TRAS.
The Hospital do Rim e Hipertensão, an agency linked to the Federal University of São Paulo (Unifesp) in Brazil, is the world leader in renal transplantation, performing an average of 1000 transplants / year in recent years. From 2006 to January 2015, patients with suspected TRAS were referred for angiography in the Hemodynamics of Hospital São Paulo.
The aims of this study was to retrospectively evaluate all patients referred to service with suspected TRAS who underwent angiography and intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with suspected transplanted renal artery stenosis and referred to the hemodynamics laboratory for angiography of the transplanted renal artery.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- refuses to participate in the study.
- patients without clinical follow-up.
- patients who did not renal transplanted at the hospital do Rim.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall mortality rate
Time frame: 08 years
overall mortality rate at the end of follow-up
graft failure rate
Time frame: 08 years
graft failure rate at the end of follow-up
2 secondary outcomes
systolic and diastolic pressure measurement in mmHg
Time frame: 01 month and 01 year
glomerular filtration rate in mL/min/1,73 m2
Time frame: 01 month and 01 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Results publication: PubMed 11376251Patel 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.
- Results publication: PubMed 19473615Henning 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.
- Results publication: PubMed 26088719Ngo 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.
- Results publication: PubMed 18670375Valpreda 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.
- Results publication: PubMed 21839234Marini 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.
- Results publication: PubMed 17629433Peregrin 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.
- Results publication: PubMed 22045446Su 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.
- Results publication: PubMed 26052624Ali 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.
- Results publication: PubMed 19776559Hurst 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.
- Results publication: PubMed 20824760Sharma 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.
- Results publication: PubMed 24354873Willicombe 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.
- Results publication: PubMed 16433762Audard 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.
- Individual participant dataSharing planned: No
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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.
Adriano HP Barbosa, MDPhD study chair
Unifesp/EPM
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant Renal Artery Stenosis, run by Adriano Henrique Pereira Barbosa at 2 sites in Brazil.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall mortality rate (time frame: 08 years). The study lists 2 primary outcomes in all. 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 NCT04225338, which also lists 18 linked publications.
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 13 Jan 2020.