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Compositions and methods for assessing acute rejection in renal transplantation

A technology for kidney transplantation and biological samples, applied in the field of compositions and methods for evaluating acute rejection in kidney transplantation, capable of solving the problems of lack of sensitive, specific and non-invasive detection

Inactive Publication Date: 2016-10-26
IMMUCOR GTI DIAGNOSTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] One of the major clinical problems facing organ transplant recipients is the lack of sensitive, specific, and non-invasive assays for continuous monitoring of patients' alloimmune thresholds and risk of acute graft rejection

Method used

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  • Compositions and methods for assessing acute rejection in renal transplantation
  • Compositions and methods for assessing acute rejection in renal transplantation
  • Compositions and methods for assessing acute rejection in renal transplantation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0134] Example 1: Study Design for Development of Compositions and Methods for Assessing Acute Rejection of Kidney Transplantation

[0135] The Assessing Acute Rejection of Kidney Transplantation (AART) study was designed as a collaborative effort of 8 kidney transplant centers around the world, using 558 peripheral blood (PB) samples from 438 adult and pediatric kidney transplant patients to develop A simple blood QPCR assay for the diagnosis and prediction of acute rejection (AR) in recipients of different immunosuppressed states and transplant center-specific procedures.

[0136] figure 1 The study design for acute assessment of renal transplant rejection (AART) in 438 independent adult / pediatric renal transplant patients from 8 transplant centers worldwide is described. Emory, UCLA, UPMC, CPMC, UCSF, and Barcelona provided adult samples, and Mexico and Stanford provided pediatric samples. For AR QPCR analysis, samples were divided into 4 cohorts: cohort 1 n = 143 adult s...

Embodiment 2

[0145] Example 2: Blood samples

[0146] Peripheral blood samples from separate pediatric (recipient age at transplant = 0.8-21.9 years; n = 200) and adult (recipient age at transplant = 23-78 years; n = 315) kidney transplant recipients (n = 518 ) was used to develop a universal peripheral blood gene panel for the noninvasive diagnosis of biopsy-determined acute renal transplant rejection. Of the 200 samples in the pediatric cohort, 177 samples were previously obtained as part of an NIH / NIAID-funded prospective multicenter clinical trial recruiting with and without histology from 12 transplant centers in the United States Patients with grade AR (SNS01; NCT00141037; www.Clinical Trials.gov; Li, L., et al. Am. J. Transplant. 2012, 12, 2710-2718). The remaining 23 samples were obtained exclusively for this study from the Nephrology Research Laboratory of the Hospital for Infantiles and Children of Mexico. Of the 315 samples in the adult cohort, samples were obtained from six t...

Embodiment 3

[0148] Example 3: Patient

[0149] Adult and Pediatric Set I

[0150] Table 5 shows Adult and Pediatric Set I.

[0151] In one example, combined pediatric and adult samples were split into two groups for testing (n=236; 143 adult, 93 pediatric) and validation (n=292; 208 adult, 84 pediatric, Table 5) .

[0152] Adult and Pediatric Episode II

[0153] In another example, the combined pediatric and adult samples were split into three groups for training and testing (n=143 adult), validation (n=124; 59 adult, 65 pediatric) and independent prediction (n=143 adult). 191; 130 adults and 61 pediatrics, Table 4).

[0154] Adult and Pediatric Episode III

[0155] In another example, the combined pediatric and adult samples were divided into 100 samples for validation (77 adult, 23 pediatric, Table 4).

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Abstract

Provided herein are methods, compositions, and kits for diagnosing acute rejection of renal transplants using the gene expression profile of sets of classifier genes. Such methods and compositions are independent of external confounders such as recipient age, transplant center, RNA source, assay, cause of end-stage renal disease, co-morbidities, immunosuppression usage, and the like.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of priority to U.S. Provisional Application No. 61 / 874,970, filed September 6, 2013, and U.S. Provisional Application No. 61 / 987,342, filed May 1, 2014, the entire contents of which are incorporated herein by reference . field of invention [0003] The present disclosure relates to methods, compositions and kits for the assessment of acute rejection of kidney transplantation using gene expression profiling of classified gene sets. The methods and compositions described are independent of external confounding factors such as age of recipient, transplant center, source of RNA, detection, cause of end-stage renal disease, comorbidities, use of immunosuppressants, etc. Background of the invention [0004] Organ transplantation from donor to host recipient is an integral part of certain medical procedures and treatment protocols. Following transplantation, it is essential to avoid rejec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/68
CPCC12Q2600/118C12Q2600/158C12Q1/6883A61P13/12
Inventor M·M·萨瓦尔
Owner IMMUCOR GTI DIAGNOSTICS
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