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| Name | Class |
|---|---|
| Clinical Trials in Organ Transplantation | NETWORK |
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There is a need to develop blood and/or urine tests that will help to detect early signs of rejection in people who have had kidney transplant. Researchers will examine blood, urine, and tissue samples and try to identify genetic markers for certain conditions like rejection, response to therapy, and scarring of the kidney. By studying gene patterns, researchers hope to be able to diagnose these conditions earlier and improve kidney survival.
Kidney transplantation is a good treatment option for people with kidney disease. However, there is still much to learn about how to best care for the transplanted kidney and keep it working for a long time. One field of interest is how one's cellular make-up might affect the body's immune response (body's natural defense system to illness and foreign things) to a kidney transplant. Cellular tests, like gene expression, help doctors to study a person's cellular traits. Gene expression is when information found in one's DNA is translated into RNA and eventually proteins. These components are present in each of the body's cells. In this study, researchers are trying to learn if certain changes in the RNA and proteins found in blood, urine, or transplant biopsy tissue can detect rejection before injury can occur or become too severe. The blood and urine tests will look for patterns in one's DNA (called genetic markers).
This study will follow subjects for 2 years after transplant. There will be a total of 12 study visits with additional study visits if rejection occurs. The study requires additional samples of blood, urine, and tissue to be collected during routine clinical visits and biopsies (a procedure to remove and examine a small piece of kidney tissue).
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Biopsy Proven Acute Rejection (AR)-Clinical and Sub-Clinical), Chronic Allograft Nephropathy/Interstitial Fibrosis and Tubular Atrophy (CAN/IFTA), and Normal Renal Biopsy with Stable, Good Kidney Function | 12 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Death | Baseline to month 24 | |
| Incidence of Graft Loss | Baseline to month 24 | |
| Incidence of Opportunistic infections |
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Inclusion Criteria:
Exclusion Criteria:
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Adults undergoing kidney transplantation.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Abecassis, MD, MBA | Northwestern University | Principal Investigator |
| John J Friedewald, MD | Northwestern University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic, Division of Nephrology | Phoenix | Arizona | 85054 | United States | ||
| The Scripps Research Institute, Scripps Center for Organ and Cell Transplantation, |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19593431 | Background | Kurian SM, Heilman R, Mondala TS, Nakorchevsky A, Hewel JA, Campbell D, Robison EH, Wang L, Lin W, Gaber L, Solez K, Shidban H, Mendez R, Schaffer RL, Fisher JS, Flechner SM, Head SR, Horvath S, Yates JR, Marsh CL, Salomon DR. Biomarkers for early and late stage chronic allograft nephropathy by proteogenomic profiling of peripheral blood. PLoS One. 2009 Jul 10;4(7):e6212. doi: 10.1371/journal.pone.0006212. | |
| 17873064 |
| Label | URL |
|---|---|
| National Institutes of Allergy and Infectious Diseases (NIAID) | View source |
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Samples of blood, urine, and tissue
| Baseline to month 24 |
| Incidence of BKV, CMV, and EBV Infection | Baseline to month 24 |
| Incidence of Treated Urinary Tract Infection | Baseline to month 24 |
| Incidence of Malignancy | Baseline to month 24 |
| Changes that Occur in Blood, Urine, and Kidney Tissue Gene Expression Signature | Month 1 to month 24 |
| Changes in Plasma Protein Expression Profile | Month 1 to month 24 |
| Changes in Urine Protein Expression Profile | Month 1 to month 24 |
| Changes in Blood MicroRNA Expression Profile | Month 1 to month 24 |
| Evolution of Gene and Protein Expression Profiles During Response to Therapy for AR | Month 1 to month 24 |
| Evolution of Gene and Protein Expression Profiles During Progression or Regression of CAN/IFTA on Protocol Biopsies | Month 1 to month 24 |
| La Jolla |
| California |
| 92037 |
| United States |
| Northwestern University, Feinberg School of Medicine, Division of Organ Transplantation | Chicago | Illinois | 60611 | United States |
| The Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Medical University of South Carolina, Division of Transplant | Charleston | South Carolina | 29425 | United States |
| Background |
| Brouard S, Mansfield E, Braud C, Li L, Giral M, Hsieh SC, Baeten D, Zhang M, Ashton-Chess J, Braudeau C, Hsieh F, Dupont A, Pallier A, Moreau A, Louis S, Ruiz C, Salvatierra O, Soulillou JP, Sarwal M. Identification of a peripheral blood transcriptional biomarker panel associated with operational renal allograft tolerance. Proc Natl Acad Sci U S A. 2007 Sep 25;104(39):15448-53. doi: 10.1073/pnas.0705834104. Epub 2007 Sep 14. |
| 17622313 | Background | Mas VR, Mas LA, Archer KJ, Yanek K, King AL, Gibney EM, Cotterell A, Fisher RA, Posner M, Maluf DG. Evaluation of gene panel mRNAs in urine samples of kidney transplant recipients as a non-invasive tool of graft function. Mol Med. 2007 May-Jun;13(5-6):315-24. doi: 10.2119/2007-00017.Mas. |
| 16319383 | Background | Muthukumar T, Dadhania D, Ding R, Snopkowski C, Naqvi R, Lee JB, Hartono C, Li B, Sharma VK, Seshan SV, Kapur S, Hancock WW, Schwartz JE, Suthanthiran M. Messenger RNA for FOXP3 in the urine of renal-allograft recipients. N Engl J Med. 2005 Dec 1;353(22):2342-51. doi: 10.1056/NEJMoa051907. |
| 17286616 | Background | Veronese F, Rotman S, Smith RN, Pelle TD, Farrell ML, Kawai T, Benedict Cosimi A, Colvin RB. Pathological and clinical correlates of FOXP3+ cells in renal allografts during acute rejection. Am J Transplant. 2007 Apr;7(4):914-22. doi: 10.1111/j.1600-6143.2006.01704.x. Epub 2007 Feb 7. |
| 24725967 | Result | Kurian SM, Williams AN, Gelbart T, Campbell D, Mondala TS, Head SR, Horvath S, Gaber L, Thompson R, Whisenant T, Lin W, Langfelder P, Robison EH, Schaffer RL, Fisher JS, Friedewald J, Flechner SM, Chan LK, Wiseman AC, Shidban H, Mendez R, Heilman R, Abecassis MM, Marsh CL, Salomon DR. Molecular classifiers for acute kidney transplant rejection in peripheral blood by whole genome gene expression profiling. Am J Transplant. 2014 May;14(5):1164-72. doi: 10.1111/ajt.12671. Epub 2014 Apr 11. |
| 42166233 | Derived | Singla A, Park S, Pedamallu H, Chen K, Robelly B, Rebello C, Lantz C, Zhao L, LaCombe R, Sinha R, Hanna G, Kleiboeker S, Mehrotra S, Friedewald J. Diagnostic Performance and Resource Utilization of Combining Blood Gene Expression, Cell-Free DNA, and Urine Chemokines for Monitoring Kidney Rejection. Clin J Am Soc Nephrol. 2026 May 21. doi: 10.2215/CJN.0000001075. Online ahead of print. |
| Clinical Trials in Organ Transplantation (CTOT) | View source |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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