Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
75 participants
Study Classification
OBSERVATIONAL
Study Start Date
2021-11-30
Study Completion Date
2023-03-01
Brief Summary
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This is a pilot 3 center prospective study of pediatric renal kidney recipients undergoing protocol biopsies examining the performance of the TruGraf gene expression test in children and adolescents.
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Detailed Description
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In pediatric renal transplant recipients, subclinical rejection in protocol biopsies is associated with a significantly increased incidence of acute rejection and/or allograft loss at 5 years post-transplant. Currently, TruGraf is the only noninvasive test designed and validated in adult kidney transplant recipients for use in ruling out silent subacute rejection in that has been approved by Medicare as an alternative to surveillance biopsies. The first step to the use of TruGraf in pediatrics is to perform a validation study in children and adolescents. Specifically, if validated in children and adolescents, a TruGraf result would enable a pediatric transplant physician to identify patients in whom no intervention is necessary without the need of a protocol biopsy. Therefore the aim of this study is to examine the concordance between the results of the TruGraf tests and protocol biopsies taken from stable pediatric renal transplant patients concurrently.
Conditions
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Kidney Transplant Rejection
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Interventions
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Patients monitored with TruGraf and TRAC testing
This is an observational study there are no protocol mandated interventions. TruGraf and TRAC results will be utilized in conjunction with standard of care assessments to determine patient management.
Intervention Type
DIAGNOSTIC_TEST
Eligibility Criteria
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Inclusion Criteria
* Patients aged 1-≤ 18 years and recipients of either living or deceased donor transplants Undergoing a protocol biopsy at either 3, 6, 12, 24 or 36 months
* Serum creatinine at the time of the clinic visit prior to the scheduled biopsy within 30% of a baseline calculated as the mean of the recipient's last 3 serum creatinine levels
* Serum creatinine level at the time of protocol biopsy ≤ 1.7 mg/dl.
* Patient receiving immunosuppression with a calcineurin inhibitor (either tacrolimus or cyclosporine) and/or an antimetabolite (either mycophenolate mofetil, mycophenolic acid EC or azathioprine) and/or an mTOR inhibitor (either sirolimus or everolimus) and/or corticosteroids.
* Absence of any systemic or urinary bacterial, viral or fungal infection
* Absence of significant BK viremia (as determined by the laboratory where the determination is run) at the time of the last clinical determination and at the time of the protocol biopsy
* Parents or guardians are capable of reading and understanding the Informed Consent document and willing to participate; if appropriate, patient is also able to understand the Informed Consent. If patient is older than 13 years, patient should be able to give Assent as written on Assent Form.
* For females of child-bearing age, a negative pregnancy test within 6 weeks of the protocol biopsy.
* Serum creatinine at the clinic visit prior to the biopsy is \> 30% of a baseline calculated as the mean of the recipient's last 3 serum creatinine levels.
* Serum creatinine at the time of the protocol biopsy ≥ 1.8 mg/dl. If the patient had a baseline \< 1.8, and the creatinine on the day of biopsy is ≥ 1.8, at the discretion of the PI, the patient will be instructed to hydrate for 4 days and a serum creatinine will be obtained at that time. This is standard clinical practice. If the creatinine returns to the baseline (i.e., ≤ 30%) range, the patient will be classified as having stable renal function, while if the patient's serum creatinine does not return to the ≤ 30% range, he/she will be classified as having renal dysfunction
* Patients who, in the estimation of the investigator, are undergoing "for-cause" biopsies.
* Presence of any current and active bacterial, viral or fungal infection
* Presence of BK viremia judged to be significant by the site PI.
* Presence of BK nephropathy
* History of PTLD or malignancy
* Parents / guardians do not understand Informed Consent and / or are unwilling to participate; patient, if of appropriate age, is unwilling to participate
* Patients manifesting recurrent disease in their transplant (such as FSGS/nephrotic syndrome, C3 Glomeruopathy, MPGN, hyperoxaluria)
* Abnormal proteinuria as determined by a urinary protein: creatinine ratio of \>1.
* Recipients of multi-organ transplants.
* Serum creatinine at the time of the clinic visit prior to the scheduled biopsy within 30% of a baseline calculated as the mean of the recipient's last 3 serum creatinine levels
* Serum creatinine level at the time of protocol biopsy ≤ 1.7 mg/dl.
* Patient receiving immunosuppression with a calcineurin inhibitor (either tacrolimus or cyclosporine) and/or an antimetabolite (either mycophenolate mofetil, mycophenolic acid EC or azathioprine) and/or an mTOR inhibitor (either sirolimus or everolimus) and/or corticosteroids.
* Absence of any systemic or urinary bacterial, viral or fungal infection
* Absence of significant BK viremia (as determined by the laboratory where the determination is run) at the time of the last clinical determination and at the time of the protocol biopsy
* Parents or guardians are capable of reading and understanding the Informed Consent document and willing to participate; if appropriate, patient is also able to understand the Informed Consent. If patient is older than 13 years, patient should be able to give Assent as written on Assent Form.
* For females of child-bearing age, a negative pregnancy test within 6 weeks of the protocol biopsy.
* Serum creatinine at the clinic visit prior to the biopsy is \> 30% of a baseline calculated as the mean of the recipient's last 3 serum creatinine levels.
* Serum creatinine at the time of the protocol biopsy ≥ 1.8 mg/dl. If the patient had a baseline \< 1.8, and the creatinine on the day of biopsy is ≥ 1.8, at the discretion of the PI, the patient will be instructed to hydrate for 4 days and a serum creatinine will be obtained at that time. This is standard clinical practice. If the creatinine returns to the baseline (i.e., ≤ 30%) range, the patient will be classified as having stable renal function, while if the patient's serum creatinine does not return to the ≤ 30% range, he/she will be classified as having renal dysfunction
* Patients who, in the estimation of the investigator, are undergoing "for-cause" biopsies.
* Presence of any current and active bacterial, viral or fungal infection
* Presence of BK viremia judged to be significant by the site PI.
* Presence of BK nephropathy
* History of PTLD or malignancy
* Parents / guardians do not understand Informed Consent and / or are unwilling to participate; patient, if of appropriate age, is unwilling to participate
* Patients manifesting recurrent disease in their transplant (such as FSGS/nephrotic syndrome, C3 Glomeruopathy, MPGN, hyperoxaluria)
* Abnormal proteinuria as determined by a urinary protein: creatinine ratio of \>1.
* Recipients of multi-organ transplants.
Exclusion Criteria
* Refusal to undergo clinical standard-of-care protocol biopsy by either parent/guardian or patient.
* Inability to obtain adequate tissue on protocol biopsy
* Inability to obtain adequate tissue on protocol biopsy
Minimum Eligible Age
1 Year
Maximum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Alabama at Birmingham
OTHER
Sponsor Role
collaborator
University of British Columbia
OTHER
Sponsor Role
collaborator
University of California, Los Angeles
OTHER
Sponsor Role
collaborator
Transplant Genomics, Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Patty West-Thielke, PharmD
Role: STUDY_DIRECTOR
Transplant Genomics
Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Site Status
RECRUITING
UCLA Mattel Children's Hospital
Los Angeles, California, United States
Site Status
RECRUITING
British Columbia Children's Hospital
Vancouver, , Canada
Site Status
RECRUITING
Countries
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United States
Canada
Central Contacts
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Facility Contacts
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References
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Moudgil A, Dharnidharka VR, Lamb KE, Meier-Kriesche HU. Best allograft survival from share-35 kidney donors occurs in middle-aged adults and young children-an analysis of OPTN data. Transplantation. 2013 Jan 27;95(2):319-25. doi: 10.1097/TP.0b013e3182719203.
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Verghese PS. Pediatric kidney transplantation: a historical review. Pediatr Res. 2017 Jan;81(1-2):259-264. doi: 10.1038/pr.2016.207. Epub 2016 Oct 12.
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Ettenger R, Albrecht R, Alloway R, Belen O, Cavaille-Coll MW, Chisholm-Burns MA, Dew MA, Fitzsimmons WE, Nickerson P, Thompson G, Vaidya P. Meeting report: FDA public meeting on patient-focused drug development and medication adherence in solid organ transplant patients. Am J Transplant. 2018 Mar;18(3):564-573. doi: 10.1111/ajt.14635. Epub 2018 Jan 25.
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Gordillo R, Munshi R, Monroe EJ, Shivaram GM, Smith JM. Benefits and risks of protocol biopsies in pediatric renal transplantation. Pediatr Nephrol. 2019 Apr;34(4):593-598. doi: 10.1007/s00467-018-3959-6. Epub 2018 May 3.
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Birk PE, Stannard KM, Konrad HB, Blydt-Hansen TD, Ogborn MR, Cheang MS, Gartner JG, Gibson IW. Surveillance biopsies are superior to functional studies for the diagnosis of acute and chronic renal allograft pathology in children. Pediatr Transplant. 2004 Feb;8(1):29-38. doi: 10.1046/j.1397-3142.2003.00122.x.
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Nankivell BJ, Agrawal N, Sharma A, Taverniti A, P'Ng CH, Shingde M, Wong G, Chapman JR. The clinical and pathological significance of borderline T cell-mediated rejection. Am J Transplant. 2019 May;19(5):1452-1463. doi: 10.1111/ajt.15197. Epub 2019 Jan 22.
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Pizzo HP, Ettenger RB, Gjertson DW, Reed EF, Zhang J, Gritsch HA, Tsai EW. Sirolimus and tacrolimus coefficient of variation is associated with rejection, donor-specific antibodies, and nonadherence. Pediatr Nephrol. 2016 Dec;31(12):2345-2352. doi: 10.1007/s00467-016-3422-5. Epub 2016 Jun 10.
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Parajuli S, Reville PK, Ellis TM, Djamali A, Mandelbrot DA. Utility of protocol kidney biopsies for de novo donor-specific antibodies. Am J Transplant. 2017 Dec;17(12):3210-3218. doi: 10.1111/ajt.14466. Epub 2017 Sep 26.
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Robert Ettenger and Margaret L. Stuber. Nonadherence, Psychosocial Adaptation and Its Effects in Pediatric Transplantation. In Textbook of Organ Transplantation, First Edition. Edited by Allan D. Kirk, Stuart J. Knechtle, Christian P. Larsen, Joren C. Madsen, Thomas C. Pearson, and Steven A. Webber. © 2014 John Wiley & Sons, Ltd. Published 2014 by John Wiley & Sons, Ltd.
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Hricik DE, Nickerson P, Formica RN, Poggio ED, Rush D, Newell KA, Goebel J, Gibson IW, Fairchild RL, Riggs M, Spain K, Ikle D, Bridges ND, Heeger PS; CTOT-01 consortium. Multicenter validation of urinary CXCL9 as a risk-stratifying biomarker for kidney transplant injury. Am J Transplant. 2013 Oct;13(10):2634-44. doi: 10.1111/ajt.12426. Epub 2013 Aug 22.
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Huang E, Sethi S, Peng A, Najjar R, Mirocha J, Haas M, Vo A, Jordan SC. Early clinical experience using donor-derived cell-free DNA to detect rejection in kidney transplant recipients. Am J Transplant. 2019 Jun;19(6):1663-1670. doi: 10.1111/ajt.15289. Epub 2019 Mar 29.
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Peddi VR, Patel PS, Schieve C, Rose S, First MR. Serial Peripheral Blood Gene Expression Profiling to Assess Immune Quiescence in Kidney Transplant Recipients with Stable Renal Function. Ann Transplant. 2020 Apr 28;25:e920839. doi: 10.12659/AOT.920839.
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Friedewald JJ, Kurian SM, Heilman RL, Whisenant TC, Poggio ED, Marsh C, Baliga P, Odim J, Brown MM, Ikle DN, Armstrong BD, Charette JI, Brietigam SS, Sustento-Reodica N, Zhao L, Kandpal M, Salomon DR, Abecassis MM; Clinical Trials in Organ Transplantation 08 (CTOT-08). Development and clinical validity of a novel blood-based molecular biomarker for subclinical acute rejection following kidney transplant. Am J Transplant. 2019 Jan;19(1):98-109. doi: 10.1111/ajt.15011. Epub 2018 Aug 31.
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Mehta R, Cherikh W, Sood P, Hariharan S. Kidney allograft surveillance biopsy practices across US transplant centers: A UNOS survey. Clin Transplant. 2017 May;31(5). doi: 10.1111/ctr.12945. Epub 2017 Mar 23.
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BACKGROUND
First MR, Peddi VR, Mannon R, Knight R, Marsh CL, Kurian SM, Rice JC, Maluf D, Mandelbrot D, Patel A, David J, Schieve C, Lee D, Lewis P, Friedewald JJ, Abecassis MM, Rose S. Investigator Assessment of the Utility of the TruGraf Molecular Diagnostic Test in Clinical Practice. Transplant Proc. 2019 Apr;51(3):729-733. doi: 10.1016/j.transproceed.2018.10.024. Epub 2018 Dec 11.
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BACKGROUND
Marsh CL, Kurian SM, Rice JC, Whisenant TC, David J, Rose S, Schieve C, Lee D, Case J, Barrick B, Peddi VR, Mannon RB, Knight R, Maluf D, Mandelbrot D, Patel A, Friedewald JJ, Abecassis MM, First MR. Application of TruGraf v1: A Novel Molecular Biomarker for Managing Kidney Transplant Recipients With Stable Renal Function. Transplant Proc. 2019 Apr;51(3):722-728. doi: 10.1016/j.transproceed.2019.01.054. Epub 2019 Jan 26.
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BACKGROUND
Naesens M. The special relativity of noninvasive biomarkers for acute rejection. Am J Transplant. 2019 Jan;19(1):5-8. doi: 10.1111/ajt.15078. Epub 2018 Sep 17. No abstract available.
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BACKGROUND
Friedewald J, Abecassis M. Clinical implications for the use of a biomarker for subclinical rejection - Conflating arguments cause a disconnection between the premise and the conclusion. Am J Transplant. 2019 Jul;19(7):2141-2142. doi: 10.1111/ajt.15327. Epub 2019 Mar 18. No abstract available.
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BACKGROUND
First MR, Whisenant T, Friedewald JJ, Lewis P, Rose S, et al. (2017) Clinical Utility of Peripheral Blood Gene Expression Profiling of Kidney Transplant Recipients to Assess the Need for Surveillance Biopsies in Subjects with Stable Renal Function. J Transplant Technol Res 7: 177.
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Loupy A, Haas M, Roufosse C, Naesens M, Adam B, Afrouzian M, Akalin E, Alachkar N, Bagnasco S, Becker JU, Cornell LD, Clahsen-van Groningen MC, Demetris AJ, Dragun D, Duong van Huyen JP, Farris AB, Fogo AB, Gibson IW, Glotz D, Gueguen J, Kikic Z, Kozakowski N, Kraus E, Lefaucheur C, Liapis H, Mannon RB, Montgomery RA, Nankivell BJ, Nickeleit V, Nickerson P, Rabant M, Racusen L, Randhawa P, Robin B, Rosales IA, Sapir-Pichhadze R, Schinstock CA, Seron D, Singh HK, Smith RN, Stegall MD, Zeevi A, Solez K, Colvin RB, Mengel M. The Banff 2019 Kidney Meeting Report (I): Updates on and clarification of criteria for T cell- and antibody-mediated rejection. Am J Transplant. 2020 Sep;20(9):2318-2331. doi: 10.1111/ajt.15898. Epub 2020 May 28.
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Schaub S, Nickerson P, Rush D, Mayr M, Hess C, Golian M, Stefura W, Hayglass K. Urinary CXCL9 and CXCL10 levels correlate with the extent of subclinical tubulitis. Am J Transplant. 2009 Jun;9(6):1347-53. doi: 10.1111/j.1600-6143.2009.02645.x. Epub 2009 May 13.
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Ho J, Rush DN, Karpinski M, Storsley L, Gibson IW, Bestland J, Gao A, Stefura W, HayGlass KT, Nickerson PW. Validation of urinary CXCL10 as a marker of borderline, subclinical, and clinical tubulitis. Transplantation. 2011 Oct 27;92(8):878-82. doi: 10.1097/TP.0b013e31822d4de1.
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Rodrigo E, Segundo DS, Fernandez-Fresnedo G, Lopez-Hoyos M, Benito A, Ruiz JC, de Cos MA, Arias M. Within-Patient Variability in Tacrolimus Blood Levels Predicts Kidney Graft Loss and Donor-Specific Antibody Development. Transplantation. 2016 Nov;100(11):2479-2485. doi: 10.1097/TP.0000000000001040.
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Kurian SM, Velazquez E, Thompson R, Whisenant T, Rose S, Riley N, Harrison F, Gelbart T, Friedewald JJ, Charette J, Brietigam S, Peysakhovich J, First MR, Abecassis MM, Salomon DR. Orthogonal Comparison of Molecular Signatures of Kidney Transplants With Subclinical and Clinical Acute Rejection: Equivalent Performance Is Agnostic to Both Technology and Platform. Am J Transplant. 2017 Aug;17(8):2103-2116. doi: 10.1111/ajt.14224. Epub 2017 Apr 3.
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Ang A, Schieve C, Rose S, Kew C, First MR, Mannon RB. Avoiding surveillance biopsy: Use of a noninvasive biomarker assay in a real-life scenario. Clin Transplant. 2021 Jan;35(1):e14145. doi: 10.1111/ctr.14145. Epub 2020 Nov 24.
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Li J, Fine J. On sample size for sensitivity and specificity in prospective diagnostic accuracy studies. Stat Med. 2004 Aug 30;23(16):2537-50. doi: 10.1002/sim.1836.
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Kanzelmeyer NK, Ahlenstiel T, Drube J, Froede K, Kreuzer M, Broecker V, Ehrich JH, Melk A, Pape L. Protocol biopsy-driven interventions after pediatric renal transplantation. Pediatr Transplant. 2010 Dec;14(8):1012-8. doi: 10.1111/j.1399-3046.2010.01399.x. Epub 2010 Sep 15.
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BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TGRP08
Identifier Type: -
Identifier Source: org_study_id
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