Renal Transplant Rejection Clinical Trial
— TITRATEOfficial title:
Addition of kSORT Assay in the Follow-up of Patients After Kidney Transplantation
Verified date | March 2018 |
Source | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the addition of "Kidney Solid Organ Rejection Test" (kSORT), in the clinical follow-up of renal transplant recipients, compared to clinical standard surveillance in the first two years after kidney transplantation. The design of the study is a partially blinded, randomized control trial of patients with living and deceased donor. The recruitment will be in a third level attention hospital in Mexico city (Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán). The main outcomes are the rate and grade of acute rejection, histologic chronic index of the one year protocol biopsy and glomerular filtration rate.
Status | Completed |
Enrollment | 70 |
Est. completion date | February 1, 2018 |
Est. primary completion date | February 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - Kidney transplant recipients from living or deceased donor from National Institute of Health and Nutrition Salvador Zubirán Exclusion Criteria: - Kidney transplant recipients who have contraindication to graft biopsy. (coagulopathy, anticoagulant therapy or double antiaggregation) |
Country | Name | City | State |
---|---|---|---|
Mexico | National Institute of Medical Sciences and Health Salvador Zubiran | Mexico DF | D.f. |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | University of California, San Francisco |
Mexico,
Li L, Khatri P, Sigdel TK, Tran T, Ying L, Vitalone MJ, Chen A, Hsieh S, Dai H, Zhang M, Naesens M, Zarkhin V, Sansanwal P, Chen R, Mindrinos M, Xiao W, Benfield M, Ettenger RB, Dharnidharka V, Mathias R, Portale A, McDonald R, Harmon W, Kershaw D, Vehask — View Citation
Meier-Kriesche HU, Ojo AO, Hanson JA, Cibrik DM, Punch JD, Leichtman AB, Kaplan B. Increased impact of acute rejection on chronic allograft failure in recent era. Transplantation. 2000 Oct 15;70(7):1098-100. — View Citation
Pallardó Mateu LM, Sancho Calabuig A, Capdevila Plaza L, Franco Esteve A. Acute rejection and late renal transplant failure: risk factors and prognosis. Nephrol Dial Transplant. 2004 Jun;19 Suppl 3:iii38-42. — View Citation
Roedder S, Sigdel T, Salomonis N, Hsieh S, Dai H, Bestard O, Metes D, Zeevi A, Gritsch A, Cheeseman J, Macedo C, Peddy R, Medeiros M, Vincenti F, Asher N, Salvatierra O, Shapiro R, Kirk A, Reed EF, Sarwal MM. The kSORT assay to detect renal transplant pat — View Citation
Sellarés J, de Freitas DG, Mengel M, Reeve J, Einecke G, Sis B, Hidalgo LG, Famulski K, Matas A, Halloran PF. Understanding the causes of kidney transplant failure: the dominant role of antibody-mediated rejection and nonadherence. Am J Transplant. 2012 F — View Citation
Thierry A, Thervet E, Vuiblet V, Goujon JM, Machet MC, Noel LH, Rioux-Leclercq N, Comoz F, Cordonnier C, François A, Marcellin L, Girardot-Seguin S, Touchard G. Long-term impact of subclinical inflammation diagnosed by protocol biopsy one year after renal transplantation. Am J Transplant. 2011 Oct;11(10):2153-61. doi: 10.1111/j.1600-6143.2011.03695.x. Epub 2011 Aug 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Immunosuppression dosage, levels and brands | Establish the assay's impact on the tacrolimus trough levels main outcome as well as on the specific brand, including the number of brand changes. We will correlate the doses and brands, and the number of brand changes of mofetil mycophenolate. | Two years | |
Other | Population genetics | Impact on the main outcomes of the population genetics, measured as major histocompatibility complex alleles and haplotipes. | Two years | |
Primary | Incidence and grade of biopsy-proven acute rejection | Based in BANFF 2013 classification, of allograft biopsies obtained during the study period | two years | |
Primary | Chronic index in one year protocol biopsy | interstitial fibrosis, tubular atrophy and chronic histomorphometry parameters | One year | |
Primary | Calculated glomerular filtration rate | Calculated glomerular filtration rate with MDRD-IDMS formula | One and two years | |
Secondary | Describe the behavior of the assay throughout the follow-up period. | Describe the behavior of kSORT assay, risk factors and consequences | Two years | |
Secondary | Determine the impact of time with positive or negative kSORT assays on the main outcomes | Determine the impact of time with positive or negative kSORT assays on the main outcomes | two years | |
Secondary | Describe the behavior of the assay after the maneuver of increasing or tapering immunosuppression and after treatment of acute rejection. | Two years | ||
Secondary | Establish the sensitivity and specificity of the kSORT assay in the detection of acute rejection | Two years | ||
Secondary | Analyze gene expression relating to renal tissue inflammation and fibrosis at the time of the one-year protocol biopsy, and their relation to clinical variables including the previous and current kSORT assay results. | One year | ||
Secondary | Hospitalization Rate | Rate of hospitalization and causes | Two years | |
Secondary | Viral Infection rate | BK virus nephritis, cytomegalovirus infection, adenovirus and herpes zoster. | Two years | |
Secondary | Graft loss rate | Graft loss rate, causes,including patient deaths. | two years |
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