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Clinical Trial
. 2018 Sep 12;19(1):229.
doi: 10.1186/s12882-018-1025-z.

A large, international study on post-transplant glomerular diseases: the TANGO project

Audrey Uffing  1 , Maria José Pérez-Sáez  1   2 , Gaetano La Manna  3 , Giorgia Comai  3 , Clara Fischman  4 , Samira Farouk  4 , Roberto Ceratti Manfro  5 , Andrea Carla Bauer  5 , Bruno Lichtenfels  5 , Juliana B Mansur  6 , Hélio Tedesco-Silva  6 , Gianna M Kirsztajn  6 , Anna Manonelles  7 , Oriol Bestard  7 , Miguel Carlos Riella  8 , Silvia Regina Hokazono  8 , Carlos Arias-Cabrales  2 , Elias David-Neto  9 , Carlucci Gualberto Ventura  9 , Enver Akalin  10 , Omar Mohammed  10 , Eliyahu V Khankin  11 , Kassem Safa  12 , Paolo Malvezzi  13 , Michelle Marie O'Shaughnessy  14 , Xingxing S Cheng  14 , Paolo Cravedi  15 , Leonardo V Riella  16
Affiliations
Clinical Trial

A large, international study on post-transplant glomerular diseases: the TANGO project

Audrey Uffing et al. BMC Nephrol. .

Abstract

Background: Long-term outcomes in kidney transplantation (KT) have not significantly improved during the past twenty years. Despite being a leading cause of graft failure, glomerular disease (GD) recurrence remains poorly understood, due to heterogeneity in disease pathogenesis and clinical presentation, reliance on histopathology to confirm disease recurrence, and the low incidence of individual GD subtypes. Large, international cohorts of patients with GD are urgently needed to better understand the disease pathophysiology, predictors of recurrence, and response to therapy.

Methods: The Post-TrANsplant GlOmerular Disease (TANGO) study is an observational, multicenter cohort study initiated in January 2017 that aims to: 1) characterize the natural history of GD after KT, 2) create a biorepository of saliva, blood, urine, stools and kidney tissue samples, and 3) establish a network of patients and centers to support novel therapeutic trials. The study includes 15 centers in America and Europe. Enrollment is open to patients with biopsy-proven GD prior to transplantation, including IgA nephropathy, membranous nephropathy, focal and segmental glomerulosclerosis, atypical hemolytic uremic syndrome, dense-deposit disease, C3 glomerulopathy, complement- and IgG-positive membranoproliferative glomerulonephritis or membranoproliferative glomerulonephritis type I-III (old classification). During phase 1, patient data will be collected in an online database. The biorepository (phase 2) will involve collection of samples from patients for identification of predictors of recurrence, biomarkers of disease activity or response to therapy, and novel pathogenic mechanisms. Finally, through phase 3, we will use our multicenter network of patients and centers to launch interventional studies.

Discussion: Most prior studies of post-transplant GD recurrence are single-center and retrospective, or rely upon registry data that frequently misclassify the cause of kidney disease. Systematically determining GD recurrence rates and predictors of clinical outcomes is essential to improving post-transplant outcomes. Furthermore, accurate molecular phenotyping and biomarker development will allow better understanding of individual GD pathogenesis, and potentially identify novel drug targets for GD in both native and transplanted kidneys. The TANGO study has the potential to tackle GD recurrence through a multicenter design and a comprehensive biorepository.

Keywords: Database; Glomerulonephritis; Kidney transplant; Recurrence; Registry.

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Conflict of interest statement

Ethics approval and consent to participate

The protocol of phase 1 of TANGO-study was submitted and approved by the Partners Human Research Committee (PHRC), (protocol number 2015P000993) and at each participating center. Documents of approval have been provided to BMC Nephrology. In one center, the University Medical Center Groningen, ethical approval was waived by the Medical Ethics review Board (METc UMCG). For retrospective data collection during phase 1 of the TANGO-study, written consent was waived in all centers. For phase 2, a biobanking protocol was also submitted and approved by the PHRC at the Brigham and Women’s hospital in Boston (protocol number 2017P000298). Ethical approval of sample collection at other centers is currently ongoing. Each center will aim to obtain IRB approval for prospective data and sample collection, and sharing across the TANGO centers. Patients will have to be consented to participate in this phase of the study.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Participating centers in the TANGO Study (image adapted from Google Maps, 2017)
See this image and copyright information in PMC

References

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