Immunosuppression Management in Renal Transplant Recipients With Transplant Excellence Based on TruGraf Test
NCT ID: NCT04670926
Last Updated: 2021-08-27
Study Results
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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UNKNOWN
NA
75 participants
INTERVENTIONAL
2021-06-03
2023-09-30
Brief Summary
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Detailed Description
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Patients who agree to participation in the study will have received Thymoglobulin induction of at least 4.5 mg/Kg body weight total dose. These patients will have their corticosteroids withdrawn by day 30 post-transplantation and will be followed with kidney function labs at least weekly through day-90 post-transplantation. Withdrawal of corticosteroids in patients who are immunologically at low risk for acute rejection similar to this study population and have received at least 4.5 mg/kg total dose of Thymoglobulin is standard practice. Patients meeting inclusion and exclusion criteria for Part-II of the study will continue with the study. Those failing to meet the inclusion/exclusion criteria for Part-II of the study will conclude the study and will be followed per CPMC standard of care.
In Part II, study patients will be randomized to one of the two groups in a 2:1 ratio. Two patients will be randomized to the study group for every one patient to the standard of care group. A total of 75 patients will be enrolled. Fifty to the study group and 25 to the standard of care group. The patients will have post transplantation follow-up labs as standard of care and clinic visits also as standard of care. There are no additional clinic visits for the study purposes or study procedures. TruGraf blood will be collected at the same time as the standard of care blood tests and additional phlebotomy is not required.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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TruGraf - Group 1:
Patients randomized to Group 1 will receive serial TruGraf testing at months 3, 4, 5, 6, 7, 8, 9, and 12. Results will be available in real-time and used by the physician to guide management of immunosuppression.
TruGraf
TruGraf results will be available in real-time and used by the physician in conjunction with other standard of care labs to guide management of immunosuppression as follows:
Patients with a stable serum creatinine and eGFR of \> 45 mL/min who also have a TruGraf TX result at month 3 will have their Mycophenolate Mofetil or Mycophenolate Sodium decreased from a standard dose of 1000 mg twice daily to 500 mg twice daily or 720 mg twice daily to 360 mg twice daily respectively.
Patients with a stable serum creatinine and estimated eGFR of \> 45 mL/min who also have a TruGraf TX result at months 4, 5, and 6 will have their Tacrolimus target trough level decreased to a target between 3 and 6.
Patients with TruGraf not-TX will have no further immunosuppression reduction and continued to be monitored.
CPMC Standard of Care - Group 2:
Patients randomized to Group 2 or CPMC Standard of Care Group patients will have current standard of care laboratory assessments.
Standard of Care
Patient's immunosuppression will be managed per the current CPMC standard of care that includes continuation of Mycophenolate Mofetil or Mycopheonolate Sodium at 1000 mg bid or 720 mg bid respectively. The dose may be decreased at the discretion of the physician for drug adverse effects such as diarrhea or other gastrointestinal side-effects or neutropenia as is the standard of care. Patients will be maintained on Tacrolimus at target levels that are considered standard of care by the managing physician.
Interventions
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TruGraf
TruGraf results will be available in real-time and used by the physician in conjunction with other standard of care labs to guide management of immunosuppression as follows:
Patients with a stable serum creatinine and eGFR of \> 45 mL/min who also have a TruGraf TX result at month 3 will have their Mycophenolate Mofetil or Mycophenolate Sodium decreased from a standard dose of 1000 mg twice daily to 500 mg twice daily or 720 mg twice daily to 360 mg twice daily respectively.
Patients with a stable serum creatinine and estimated eGFR of \> 45 mL/min who also have a TruGraf TX result at months 4, 5, and 6 will have their Tacrolimus target trough level decreased to a target between 3 and 6.
Patients with TruGraf not-TX will have no further immunosuppression reduction and continued to be monitored.
Standard of Care
Patient's immunosuppression will be managed per the current CPMC standard of care that includes continuation of Mycophenolate Mofetil or Mycopheonolate Sodium at 1000 mg bid or 720 mg bid respectively. The dose may be decreased at the discretion of the physician for drug adverse effects such as diarrhea or other gastrointestinal side-effects or neutropenia as is the standard of care. Patients will be maintained on Tacrolimus at target levels that are considered standard of care by the managing physician.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have the ability to understand the requirements of the study and are able to provide written informed consent.
3. Recipient of a primary deceased-donor or living donor kidney transplant.
4. Patients at low-immunological risk for acute rejection defined as cPRA of less than 50; no DSA; non-African American recipients
5. HLA crossmatch negative (virtual cross match acceptable)
6. Allograft from a deceased donor with KDPI \< 50%
1. Stable serum creatinine level and estimated eGFR of \> 45 mL/min at 90 days post-transplantation
2. Kidney transplant patients who are more than 90 days post-transplant.
3. Patients who have received Thymoglobulin induction therapy (\> 4.5 mg/kg) and tolerated corticosteroid withdrawal.
Exclusion Criteria
2. Need for combined organ transplantation with an extra-renal organ transplant.
3. Recipients of previous non-renal solid organ and/or islet cell transplantation.
4. Infection with HIV
5. Patients with Hepatitis B or C PCR positive.
6. Patients on corticosteroids at the time of transplantation
7. Patients with leucopenia (WBC \<3.0) and thrombocytopenia (platelets \<100)
8. Patients who will NOT receive Thymoglobulin induction (\>4.5 mg/kg total dose)
9. HLA-identical living related renal transplant recipients
Part-II
1. Infection with BK viremia with viral loads 10,000 copies/mL.
2. Patients with proteinuria (urine protein \>1 gm/gm of creatinine).
3. Patients diagnosed with acute allograft rejection of any grade
18 Years
ALL
No
Sponsors
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California Pacific Medical Center
OTHER
Transplant Genomics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ram Peddi
Role: PRINCIPAL_INVESTIGATOR
California Pacific Medical Center
Patty West-Thielke, PharmD
Role: STUDY_DIRECTOR
Eurofins-TGI
Locations
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California Pacific Medical Center
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Matas AJ, Gillingham KJ, Humar A, Kandaswamy R, Sutherland DE, Payne WD, Dunn TB, Najarian JS. 2202 kidney transplant recipients with 10 years of graft function: what happens next? Am J Transplant. 2008 Nov;8(11):2410-9. doi: 10.1111/j.1600-6143.2008.02414.x.
Lamb KE, Lodhi S, Meier-Kriesche HU. Long-term renal allograft survival in the United States: a critical reappraisal. Am J Transplant. 2011 Mar;11(3):450-62. doi: 10.1111/j.1600-6143.2010.03283.x. Epub 2010 Oct 25.
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Choi BS, Shin MJ, Shin SJ, Kim YS, Choi YJ, Kim YS, Moon IS, Kim SY, Koh YB, Bang BK, Yang CW. Clinical significance of an early protocol biopsy in living-donor renal transplantation: ten-year experience at a single center. Am J Transplant. 2005 Jun;5(6):1354-60. doi: 10.1111/j.1600-6143.2005.00830.x.
Seron D, Moreso F. Protocol biopsies in renal transplantation: prognostic value of structural monitoring. Kidney Int. 2007 Sep;72(6):690-7. doi: 10.1038/sj.ki.5002396. Epub 2007 Jun 27.
Heilman RL, Devarapalli Y, Chakkera HA, Mekeel KL, Moss AA, Mulligan DC, Mazur MJ, Hamawi K, Williams JW, Reddy KS. Impact of subclinical inflammation on the development of interstitial fibrosis and tubular atrophy in kidney transplant recipients. Am J Transplant. 2010 Mar;10(3):563-70. doi: 10.1111/j.1600-6143.2009.02966.x. Epub 2010 Feb 1.
Rush DN, Henry SF, Jeffery JR, Schroeder TJ, Gough J. Histological findings in early routine biopsies of stable renal allograft recipients. Transplantation. 1994 Jan;57(2):208-11. doi: 10.1097/00007890-199401001-00009.
Kirk AD, Jacobson LM, Heisey DM, Radke NF, Pirsch JD, Sollinger HW. Clinically stable human renal allografts contain histological and RNA-based findings that correlate with deteriorating graft function. Transplantation. 1999 Nov 27;68(10):1578-82. doi: 10.1097/00007890-199911270-00024.
Moreso F, Ibernon M, Goma M, Carrera M, Fulladosa X, Hueso M, Gil-Vernet S, Cruzado JM, Torras J, Grinyo JM, Seron D. Subclinical rejection associated with chronic allograft nephropathy in protocol biopsies as a risk factor for late graft loss. Am J Transplant. 2006 Apr;6(4):747-52. doi: 10.1111/j.1600-6143.2005.01230.x.
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Lo DJ, Kaplan B, Kirk AD. Biomarkers for kidney transplant rejection. Nat Rev Nephrol. 2014 Apr;10(4):215-25. doi: 10.1038/nrneph.2013.281. Epub 2014 Jan 21.
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.
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Other Identifiers
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TGRP07
Identifier Type: -
Identifier Source: org_study_id
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