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Methods and compositions for the prediction and treatment of focal segmental glomerulosclerosis

a technology of glomerulosclerosis and compositions, applied in the direction of immunoglobulins, instruments, peptides, etc., can solve the problems of significant clinical challenges, potential detrimental course toward the loss of renal function, and subsequent treatment, and achieve the effect of positively affecting graft function and survival

Inactive Publication Date: 2020-01-16
SARWAL MINNIE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patent is about methods, compositions, and kits for identifying and predicting the risk of developing various kidney diseases, such as recurrent FSGS, native FSGS, minimal change disease, glomerular nephritis, membrano-proliferative glomerular nephritis (membranous), or IgA glomerular nephritis (membranous). It also provides information on preventing these diseases from occurring by administering a blocking factor to individuals who are at risk. The method can be carried out after kidney transplantation and may involve the use of plasmaphresis, antibody immuadsorption, or rituximab. Overall, this patent provides a useful tool for managing and treating kidney diseases that target the immune system.

Problems solved by technology

Recurrence of focal segmental glomerulosclerosis (rFSGS) after kidney transplantation :leads to graft loss and has a potentially detrimental course toward the loss of renal function.
Observations notwithstanding, improvements in pre-transplant risk stratification for rFSGS, nFSGS, minimal change disease, and other proteinuric kidney diseases and subsequent treatment remain a major clinical challenge.

Method used

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  • Methods and compositions for the prediction and treatment of focal segmental glomerulosclerosis
  • Methods and compositions for the prediction and treatment of focal segmental glomerulosclerosis
  • Methods and compositions for the prediction and treatment of focal segmental glomerulosclerosis

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example 1

Materials and Methods

[0177]Patients and Samples: 141 sera samples, obtained prior to and one year after renal transplantation, were processed from 98 unique renal transplant patients, enrolled from 5 international transplant centers: Transplantation Renale Adulte, Hopital Necker-Enfants Malades (Paris, France); John Hopkins Hospital (Baltimore, Mass.), and Nephrology and Renal Transplantation, University Hospitals Leuven (Leuven, Belgium),The study was approved by the Institutional Review Board of California Pacific Medical Center, Stanford University, Necker, John Hopkins and Leuven for biobanking and samples analysis.

[0178]Immune Response Biomarker Profiling by Protein Microarrays and ELISA Validation: The ProtoArray(R) human protein microarray was used for profiling serum IgG autoantibody in 20 pre-transplant sera from 10 patients with and without rFSGS. The Meso Scale Discovery® (MSD) technology was used for customized ELISA validation for elevated antibody titers in rFSGS to FA...

example 2

Identification of Antibodies Associated with rESGS After Renal Transplantation

[0183]To identify potential autoantibodies associated with rFSGS, a discovery set of pre-transplant sera was used. The discovery set was from from 20 unique patients with biopsy confirmed diagnosis of FSGS as their cause of End Stage Renal disease (ESRD), of which 10 had progressed to rFSGS within the first post-transplant year (mean time to recurrence 36 days) and 10 FSGS patients had not had recurrence of proteinuria or histological disease after transplantation (nrFSGS). At transplant, these two groups of patients were indistinguishable regarding demographical or clinical parameters (Table 1). Recurrence was defined by heavy proteinuria with biopsy confirmation of FSGS with glomerular sclerosis and podocyte fusion and injury without evidence of acute rejection, glomerulitis or allograft glomerulopathy. Sera samples were assayed on high-density protein microarrays (Protoarray v5.0; Life Technologies). FI...

example 3

ELISA Validation of Antibodies that can Predict rFSGS After Renal Transplantation-Cross-Sectional and Longitudinal Analyses

[0185]Customized ELISA assays were generated as previously described [18] for the autoantibodies shown in Table 2. 132 unique sera were processed for customized ELISA assays for all 10 autoantibodies in Table 2. Sera were obtained from 55 patients with FSGS as a cause of ESRD prior to transplantation; 27 of these patients had rFSGS within the first year post-transplant and 28 did not. Patients were demographically matched (Table 1) (FIG. 1). In a subset of these patients, follow-up sera samples were available at one year post-transplantation (17 with rFSGS in the first post-transplant year and 26 patients without recurrence); the customized ELISA assays for all 10 autoantibodies were also run on these samples to obtain a longitudinal analysis of antibody titres in the first post-transplant year. ELISA analyses confirmed that antibodies against CD40 (p=0,0002), S...

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Abstract

Provided herein are methods and compositions for the prediction and treatment of focal segmental glomerulosclerosis and oilier proteinuric renal diseases such as native FSGS, minimal change disease, glomerular nephritis, membrano-proliferative glomerular nephritis (membranous), or IgA glomerular nephritis (membranous).

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority to U.S. Provisional Application Serial No. 61 / 975,692, filed on Apr. 4, 2014, which is incorporated herein by reference in its entiretyBACKGROUND OF THE INVENTION[0002]Primary Focal Segmental Glomerulosclerosis (FSGS) is a proteinuric glomerular disease that affects podocyte function and survival and results in a typical pattern of histopathological injury including glomerulosclerosis on kidney biopsy [1, 2].[0003]Renal transplant patients with primary FSGS or native FSGS face a high risk of recurrence of FSGS (recurrent FSGS, rFDGS) in the allograft (20 to 40% after a first transplant and up to 80% for re-transplantation) [3, 4]. Recurrence of focal segmental glomerulosclerosis (rFSGS) after kidney transplantation :leads to graft loss and has a potentially detrimental course toward the loss of renal function.[0004]Native FSGS (nFSGS) can develop from a variety of causes, including genetic, toxicity, or fo...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): G01N33/564C07K16/28
CPCG01N33/564C07K2317/34C07K2317/21C07K16/2878
Inventor SARWAL, MINNIE
Owner SARWAL MINNIE
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