Kidney Transplant RejectionNCT04670926
Immunosuppression Management in Renal Transplant Recipients With Transplant Excellence Based on TruGraf Test
A study testing TruGraf in people with Kidney Transplant Rejection and Immunosuppression, run by Transplant Genomics, Inc. at 1 site in United States.
Trial summary
This is an investigator-initiated, single-center, prospective, randomized, proof of concept study. In this study patients who are status post kidney transplantation and meet the inclusion and exclusion criteria will undergo immunosuppression reduction and will be followed closely to assess stability of graft function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Rejection, Immunosuppression
- What is being tested?
- TruGraf
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Part-I
Inclusion Criteria: Patients who meet all of the following criteria are eligible for enrollment:
- All males or females of at least 18 years of age.
- Have the ability to understand the requirements of the study and are able to provide written informed consent.
- Recipient of a primary deceased-donor or living donor kidney transplant.
- Patients at low-immunological risk for acute rejection defined as cPRA of less than 50; no DSA; non-African American recipients
- HLA crossmatch negative (virtual cross match acceptable)
- Allograft from a deceased donor with KDPI < 50%
Exclusion Criteria: Patients who meet any of the following criteria are not eligible for enrollment:
- Inability or unwillingness to provide informed consent.
- Need for combined organ transplantation with an extra-renal organ transplant.
- Recipients of previous non-renal solid organ and/or islet cell transplantation.
- Infection with HIV
- Patients with Hepatitis B or C PCR positive.
- Patients on corticosteroids at the time of transplantation
- Patients with leucopenia (WBC <3.0) and thrombocytopenia (platelets <100)
- Patients who will NOT receive Thymoglobulin induction (>4.5 mg/kg total dose)
- HLA-identical living related renal transplant recipients
Part-II
Inclusion Criteria: Patients who meet all of the following criteria are eligible for enrollment:
- Stable serum creatinine level and estimated eGFR of > 45 mL/min at 90 days post-transplantation
- Kidney transplant patients who are more than 90 days post-transplant.
- Patients who have received Thymoglobulin induction therapy (> 4.5 mg/kg) and tolerated corticosteroid withdrawal.
Exclusion Criteria: Patients who meet any of these criteria are not eligible for enrollment:
- Infection with BK viremia with viral loads 10,000 copies/mL.
- Patients with proteinuria (urine protein >1 gm/gm of creatinine).
- Patients diagnosed with acute allograft rejection of any grade
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
California Pacific Medical Center
San Francisco, California, 94115
Ram Peddi, 415-600-1063, peddir@sutterhealth.org
About this study
This is an investigator-initiated, single-center, prospective, randomized, proof of concept study. In this study patients who are status post kidney transplantation and meet the inclusion and exclusion criteria will undergo immunosuppression reduction and will be followed closely to assess stability of graft function.
Read the detailed description
The study will consist of 2 parts (Part-I and Part-II). In Part I of the study, kidney transplant recipients who are low-risk for rejection and meet the inclusion and exclusion criteria for study Part-I will be approached for informed consent in the peri-transplant period, defined as 7 days before to 5 days after transplantation. Basic clinical history and kidney transplant function that are reviewed for routine transplant care are utilized to screen patients who are approached for study discussion and informed consent.
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
- Kidney Transplant Rejection, Immunosuppression
- Being tested
- TruGraf, Standard of Care
- Keywords
- kidney transplant, immunosuppression, biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruGrafDiagnostic test
Also called TruGraf Blood Gene Expression Test
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| TruGraf - Group 1: | Experimental | 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. Receives: Diagnostic Test: TruGraf |
| CPMC Standard of Care - Group 2: | Active comparator | Patients randomized to Group 2 or CPMC Standard of Care Group patients will have current standard of care laboratory assessments. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physicians decided to reduce immunosuppression
Percent or total number of patients who physicians decided could reduce immunosuppression.
Measured: Baseline to month 12
Banff pathology
Banff pathology will be assessed for all study subjects receiving a biopsy during the study period (if performed).
Measured: Baseline to month 12
Cost of patient care
The cost of patient care will be evaluated by measuring the total health care spending for health care services provided during the study period.
Measured: Baseline to month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start3 Jun 2021
- Primary completion3 Jun 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transplant Genomics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- California Pacific Medical Center
- Responsible party
- Sponsor
- Investigators
- Ram Peddi, Principal investigator, California Pacific Medical CenterPatty West-Thielke, PharmD, Study director, Eurofins-TGI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670926
- Sponsor's protocol ID
- TGRP07
- Status last verified
- Aug 2021
- First submitted
- 10 Dec 2020
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rana A, Gruessner A, Agopian VG, Khalpey Z, Riaz IB, Kaplan B, Halazun KJ, Busuttil RW, Gruessner RW. Survival benefit of solid-organ transplant in the United States. JAMA Surg. 2015 Mar 1;150(3):252-9. doi: 10.1001/jamasurg.2014.2038.
PubMed 25629390Matas 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.
PubMed 18925907Lamb 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.
PubMed 20973913Montgomery RA. One kidney for life. Am J Transplant. 2014 Jul;14(7):1473-4. doi: 10.1111/ajt.12772. Epub 2014 May 9. No abstract available.
PubMed 24816339Waldmann H. Drug minimization in transplantation: an opinion. Curr Opin Organ Transplant. 2014 Aug;19(4):331-3. doi: 10.1097/MOT.0000000000000099. No abstract available.
PubMed 24991978Racusen LC, Solez K, Colvin RB, Bonsib SM, Castro MC, Cavallo T, Croker BP, Demetris AJ, Drachenberg CB, Fogo AB, Furness P, Gaber LW, Gibson IW, Glotz D, Goldberg JC, Grande J, Halloran PF, Hansen HE, Hartley B, Hayry PJ, Hill CM, Hoffman EO, Hunsicker LG, Lindblad AS, Yamaguchi Y, et al. The Banff 97 working classification of renal allograft pathology. Kidney Int. 1999 Feb;55(2):713-23. doi: 10.1046/j.1523-1755.1999.00299.x.
PubMed 9987096Rush D, Nickerson P, Gough J, McKenna R, Grimm P, Cheang M, Trpkov K, Solez K, Jeffery J. Beneficial effects of treatment of early subclinical rejection: a randomized study. J Am Soc Nephrol. 1998 Nov;9(11):2129-34. doi: 10.1681/ASN.V9112129.
PubMed 9808101Burghardt KM, Wales PW, de Silva N, Stephens D, Yap J, Grant D, Avitzur Y. Pediatric intestinal transplant listing criteria - a call for a change in the new era of intestinal failure outcomes. Am J Transplant. 2015 Jun;15(6):1674-81. doi: 10.1111/ajt.13147. Epub 2015 Mar 23.
PubMed 25809131Legendre C, Thervet E, Skhiri H, Mamzer-Bruneel MF, Cantarovich F, Noel LH, Kreis H. Histologic features of chronic allograft nephropathy revealed by protocol biopsies in kidney transplant recipients. Transplantation. 1998 Jun 15;65(11):1506-9. doi: 10.1097/00007890-199806150-00020.
PubMed 9645814Choi 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.
PubMed 15888041Seron 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.
PubMed 17597702Heilman 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.
PubMed 20121731Rush 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.
PubMed 8310509Kirk 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.
PubMed 10589958Moreso 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.
PubMed 16539631
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunosuppression Management in Renal Transplant Recipients With Transplant Excellence Based on TruGraf Test
- ClinicalTrials.gov ID
- NCT04670926
- Acronym / sponsor ID
- TGRP07
- Conditions
- Kidney Transplant Rejection, Immunosuppression
- Keywords
- kidney transplant, immunosuppression, biomarkers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Transplant Genomics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- California Pacific Medical Center
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 3 Jun 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an investigator-initiated, single-center, prospective, randomized, proof of concept study. In this study patients who are status post kidney transplantation and meet the inclusion and exclusion criteria will undergo immunosuppression reduction and will be followed closely to assess stability of graft function.
Detailed description
The study will consist of 2 parts (Part-I and Part-II). In Part I of the study, kidney transplant recipients who are low-risk for rejection and meet the inclusion and exclusion criteria for study Part-I will be approached for informed consent in the peri-transplant period, defined as 7 days before to 5 days after transplantation. Basic clinical history and kidney transplant function that are reviewed for routine transplant care are utilized to screen patients who are approached for study discussion and informed consent.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TruGraf - Group 1: | Experimental | Diagnostic Test: TruGrafPatients 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. |
| CPMC Standard of Care - Group 2: | Active comparator | Other: Standard of CarePatients randomized to Group 2 or CPMC Standard of Care Group patients will have current standard of care laboratory assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TruGrafAlso: TruGraf Blood Gene Expression TestTruGraf 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. | Diagnostic test | TruGraf - Group 1: |
| Standard of CarePatient'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 | CPMC Standard of Care - Group 2: |
Primary outcome
Physicians decided to reduce immunosuppression
Time frame: Baseline to month 12
Percent or total number of patients who physicians decided could reduce immunosuppression.
Banff pathology
Time frame: Baseline to month 12
Banff pathology will be assessed for all study subjects receiving a biopsy during the study period (if performed).
Cost of patient care
Time frame: Baseline to month 12
The cost of patient care will be evaluated by measuring the total health care spending for health care services provided during the study period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Background: PubMed 25629390Rana A, Gruessner A, Agopian VG, Khalpey Z, Riaz IB, Kaplan B, Halazun KJ, Busuttil RW, Gruessner RW. Survival benefit of solid-organ transplant in the United States. JAMA Surg. 2015 Mar 1;150(3):252-9. doi: 10.1001/jamasurg.2014.2038.
- Background: PubMed 18925907Matas 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.
- Background: PubMed 20973913Lamb 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.
- Background: PubMed 24816339Montgomery RA. One kidney for life. Am J Transplant. 2014 Jul;14(7):1473-4. doi: 10.1111/ajt.12772. Epub 2014 May 9. No abstract available.
- Background: PubMed 24991978Waldmann H. Drug minimization in transplantation: an opinion. Curr Opin Organ Transplant. 2014 Aug;19(4):331-3. doi: 10.1097/MOT.0000000000000099. No abstract available.
- Background: PubMed 9987096Racusen LC, Solez K, Colvin RB, Bonsib SM, Castro MC, Cavallo T, Croker BP, Demetris AJ, Drachenberg CB, Fogo AB, Furness P, Gaber LW, Gibson IW, Glotz D, Goldberg JC, Grande J, Halloran PF, Hansen HE, Hartley B, Hayry PJ, Hill CM, Hoffman EO, Hunsicker LG, Lindblad AS, Yamaguchi Y, et al. The Banff 97 working classification of renal allograft pathology. Kidney Int. 1999 Feb;55(2):713-23. doi: 10.1046/j.1523-1755.1999.00299.x.
- Background: PubMed 9808101Rush D, Nickerson P, Gough J, McKenna R, Grimm P, Cheang M, Trpkov K, Solez K, Jeffery J. Beneficial effects of treatment of early subclinical rejection: a randomized study. J Am Soc Nephrol. 1998 Nov;9(11):2129-34. doi: 10.1681/ASN.V9112129.
- Background: PubMed 25809131Burghardt KM, Wales PW, de Silva N, Stephens D, Yap J, Grant D, Avitzur Y. Pediatric intestinal transplant listing criteria - a call for a change in the new era of intestinal failure outcomes. Am J Transplant. 2015 Jun;15(6):1674-81. doi: 10.1111/ajt.13147. Epub 2015 Mar 23.
- Background: PubMed 9645814Legendre C, Thervet E, Skhiri H, Mamzer-Bruneel MF, Cantarovich F, Noel LH, Kreis H. Histologic features of chronic allograft nephropathy revealed by protocol biopsies in kidney transplant recipients. Transplantation. 1998 Jun 15;65(11):1506-9. doi: 10.1097/00007890-199806150-00020.
- Background: PubMed 15888041Choi 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.
- Background: PubMed 17597702Seron 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.
- Background: PubMed 20121731Heilman 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.
- Individual participant dataSharing planned: No
Related trials for Kidney Transplant Rejection
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
Not yet recruitingObservational study
Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
Renal Transplantation; Complication, Renal Transplant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ram Peddi principal investigator
California Pacific Medical Center
Patty West-Thielke, PharmD study director
Eurofins-TGI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TruGraf in people with Kidney Transplant Rejection and Immunosuppression, run by Transplant Genomics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cortney C Miller, PhD (5107753326, cortneymiller@eurofins-tgi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physicians decided to reduce immunosuppression (time frame: Baseline to month 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04670926, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.