Kidney Transplant RejectionCLARITYNCT05482100
CLinical Utility of the omnigrAf® biomarkeR Panel In The Care of kidneY Transplant Recipients
An observational study of Kidney Transplant Rejection, run by Transplant Genomics, Inc..
Trial summary
This is a prospective, multi-site, observational study with a matched control group. The primary objective is to evaluate change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM monitoring in conjunction with patient medication-related burden monitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- Patients monitored with OmniGraf testing
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to 1 Jun 2026
- Phase
- Observational
- 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
Study population: This study is an observational study in adult (age ≥ 18 years), kidney transplant patients who are at 3 months to 2 years from the time of transplant. Approximately 500 subjects will be enrolled.
Who may be able to join
- Written informed consent and HIPAA authorization;
- At least 18 years of age;
- Recipient of a primary or subsequent deceased-donor or living-donor kidney transplant;
- Between 3 months and 2 years post-transplant;
- Selected by provider to undergo OmniGraf™ testing as part of usual post-transplant care
Who cannot join
- Recipient of a combined organ transplant with an extra-renal organ and/or islet cell transplant;
- Recipient of a previous non-renal solid organ and/or islet cell transplant;
- Known to be pregnant;
- Known to be infected with Human Immunodeficiency Virus (HIV);
- Known to have active BK nephropathy;
- Known to have nephrotic proteinuria (per principal investigator); or
- Participation in other biomarker studies
Trial locations and contacts
No sites are listed yet.
James Fleming, PharmD contact
About this study
This is a prospective, multi-site, observational study with a matched control group. The primary objective is to evaluate change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM monitoring in conjunction with patient medication-related burden monitoring.
Read the detailed description
The survival benefits of solid organ transplants in the United States are well documented. Improvements in immunosuppression, better anti-microbial agents, and other aspects of ancillary care have resulted in significant improvements in short- term outcomes; however, there has been little improvement in long-term graft loss. A more recent analysis found that 65% of hospital readmissions in kidney transplant recipients had adverse drug events (ADE) considered contributory, and ADE-associated readmissions had a significantly higher hazard or graft loss and death compared to patients with readmissions not associated with an ADE. Even with knowledge of ADEs, clinicians may be reluctant to adjust immunosuppressive medications due to concerns of rejection risk during the period of medication adjustment. The OmniGrafTM biomarker panel (Transplant Genomics, Inc, Framingham, MA) includes the TruGraf® peripheral blood expression profile and the TRAC donor-derived cell-free DNA(dd-cfDNA) test, which have demonstrated a strong ability to identify immune quiescence in stable patients post kidney transplant, with a NPV of 94% when both tests are negative and a PPV of 89% for subclinical rejection when both tests are positive. Because of the strong "rule out" capabilities of OmniGrafTM, it would be an ideal complement to real-time ADE knowledge to help guide clinicians' decisions to adjust, or not adjust, the immunosuppressive regimen, and help provide a dialogue between patients and clinicians on the risk-benefit of medication adjustments. The aim of this study is to evaluate change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM monitoring in conjunction with patient medication-related burden monitoring.
- Conditions
- Kidney Transplant Rejection
- Being tested
- Patients monitored with OmniGraf testing
- Keywords
- Biomarkers, Subclinical Rejection, Immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients monitored with OmniGraf testingDiagnostic test
This is an observational study there are no protocol mandated interventions. OmniGraf results will be utilized in conjunction with standard of care assessments to determine patient management.
| Study group | Role | What they receive |
|---|---|---|
| Patients monitored with OmniGraf Testing | Subjects will have OmniGraf™ testing at study enrollment and thereafter every 3 months or at the same time as standard routine labs (minimum two per year). In addition, subjects will have OmniGraf™ testing at any time there is a workup for clinical events and referral to advanced care (transplant center, biopsy, etc) Receives: Diagnostic Test: Patients monitored with OmniGraf testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
GFR changes between study group and matched control group
Comparison of the slope change in estimated glomerular filtration rate (eGFR), calculated using the MDRD 4-variable equation and CKD-EPI, from baseline to the end of follow-up between study participants and a matched control group.
Measured: 3 years
Secondary outcomes (13)
PROMISE and Self efficacy results from baseline to study completion
Comparison of the Patient-Reported Outcomes Measurement Information System(PROMIS) Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment-Short Form 4a (Self-Efficacy) at the end of follow-up to baseline PROMIS tools were developed to be disease non-specific measures of health-related domains. Each domain in composed of an item bank specific to a trait being measured. Item banks are calibrated on a common scale to facilitate comparability across varying populations. Depression is measured by various questions with answers ranging from never to always.
Raw scores are transformed to standardized T-score metrics, with a mean of 50 and standard deviation of 10
Measured: 3 years
PROMISE results from baseline to study completion
Comparison of the PROMIS-29 Profile v2.1 at the end of follow-up to baseline PROMIS tools were developed to be disease non-specific measures of health-related domains. Each domain in composed of an item bank specific to a trait being measured. Item banks are calibrated on a common scale to facilitate comparability across varying populations. Depression is measured by various questions with answers ranging from never to always.
Raw scores are transformed to standardized T-score metrics, with a mean of 50 and standard deviation of 10
Measured: 3 years
PROMIS Depression scale from baseline to study completion
Comparison of the PROMIS Depression scale at the end of follow-up to baseline. PROMIS tools were developed to be disease non-specific measures of health-related domains such as self-efficacy for symptom and medication management, depression, anxiety, fatigue, pain interference, sleep disturbance, and physical functioning. Each domain in composed of an item bank specific to a trait being measured. Item banks are calibrated on a common scale to facilitate comparability across varying populations. Depression is measured by various questions with answers ranging from never to always.
Measured: 3 years
Comparison of Hospitlizations due to infections in the matched control and study group
Rate of hospitalizations, subcategorized for hospitalizations due to infections, compared between study participants and a matched control group
Measured: 3 years
Comparison of rejection of matched control and study group
Incidence of treated rejections, compared between study participants and a matched control group
Measured: 3 years
MRSB
Medication-Related Symptom Burden (MRSB), as defined as the change in number and severity of adverse effects
Measured: 3 years
Graft survival at 3 years comparison of matched control vs. study group
Proportion of subjects with overall graft survival (including death with a functioning allograft) at year 3 post-transplant, compared between study participants and a matched control group
Measured: 3 years
Graft survival at 1-2 years comparison of matched control vs. study group
Proportion of subjects with overall graft survival at year 1 and year 2 post-enrollment, compared between study participants and a matched control group
Measured: 2 years
Graft loss during study period
Number of participants with graft loss, defined as permanent return to dialysis, retransplantation or patient death at any time during the 3-year primary follow-up study period;
Measured: 3 years
Graft survival during study period
Graft survival calculated from the date of kidney transplantation until date of graft loss
Measured: 3 years
Death-censored graft loss
Number of participants with death-censored graft loss, defined as permanent return to dialysis or retransplantation at any time during the 3-year primary follow-up study period. Patients who die with a functioning graft will be right censored
Measured: 3 years
Patient death during study period
Number of participants with patient death from any cause at any time during the 3-year primary follow-up study period
Measured: 3 years
Provider changes during study period
Rate of change in provider satisfaction from baseline to the end of follow-up using questionnaire
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study startSep 2022 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transplant Genomics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patty West-Thielke, PharmD, Study director, Transplant Genomics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482100
- Sponsor's protocol ID
- TGRP11
- Acronym
- CLARITY
- Status last verified
- Jul 2022
- First submitted
- 18 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tonelli M, Wiebe N, Knoll G, Bello A, Browne S, Jadhav D, Klarenbach S, Gill J. Systematic review: kidney transplantation compared with dialysis in clinically relevant outcomes. Am J Transplant. 2011 Oct;11(10):2093-109. doi: 10.1111/j.1600-6143.2011.03686.x. Epub 2011 Aug 30.
PubMed 21883901Saran R, Robinson B, Abbott KC, Agodoa LY, Albertus P, Ayanian J, Balkrishnan R, Bragg-Gresham J, Cao J, Chen JL, Cope E, Dharmarajan S, Dietrich X, Eckard A, Eggers PW, Gaber C, Gillen D, Gipson D, Gu H, Hailpern SM, Hall YN, Han Y, He K, Hebert H, Helmuth M, Herman W, Heung M, Hutton D, Jacobsen SJ, Ji N, Jin Y, Kalantar-Zadeh K, Kapke A, Katz R, Kovesdy CP, Kurtz V, Lavalee D, Li Y, Lu Y, McCullough K, Molnar MZ, Montez-Rath M, Morgenstern H, Mu Q, Mukhopadhyay P, Nallamothu B, Nguyen DV, Norris KC, O'Hare AM, Obi Y, Pearson J, Pisoni R, Plattner B, Port FK, Potukuchi P, Rao P, Ratkowiak K, Ravel V, Ray D, Rhee CM, Schaubel DE, Selewski DT, Shaw S, Shi J, Shieu M, Sim JJ, Song P, Soohoo M, Steffick D, Streja E, Tamura MK, Tentori F, Tilea A, Tong L, Turf M, Wang D, Wang M, Woodside K, Wyncott A, Xin X, Zang W, Zepel L, Zhang S, Zho H, Hirth RA, Shahinian V. US Renal Data System 2016 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2017 Mar;69(3 Suppl 1):A7-A8. doi: 10.1053/j.ajkd.2016.12.004. No abstract available.
PubMed 28236831Hart A, Smith JM, Skeans MA, Gustafson SK, Stewart DE, Cherikh WS, Wainright JL, Boyle G, Snyder JJ, Kasiske BL, Israni AK. Kidney. Am J Transplant. 2016 Jan;16 Suppl 2(Suppl 2):11-46. doi: 10.1111/ajt.13666.
PubMed 26755262Meier-Kriesche HU, Schold JD, Srinivas TR, Kaplan B. Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era. Am J Transplant. 2004 Mar;4(3):378-83. doi: 10.1111/j.1600-6143.2004.00332.x.
PubMed 14961990Lentine KL, Smith JM, Hart A, Miller J, Skeans MA, Larkin L, Robinson A, Gauntt K, Israni AK, Hirose R, Snyder JJ. OPTN/SRTR 2020 Annual Data Report: Kidney. Am J Transplant. 2022 Mar;22 Suppl 2:21-136. doi: 10.1111/ajt.16982.
PubMed 35266618El-Zoghby ZM, Stegall MD, Lager DJ, Kremers WK, Amer H, Gloor JM, Cosio FG. Identifying specific causes of kidney allograft loss. Am J Transplant. 2009 Mar;9(3):527-35. doi: 10.1111/j.1600-6143.2008.02519.x. Epub 2008 Feb 3.
PubMed 19191769Arms MA, Fleming J, Sangani DB, Nadig SN, McGillicuddy JW, Taber DJ. Incidence and impact of adverse drug events contributing to hospital readmissions in kidney transplant recipients. Surgery. 2018 Feb;163(2):430-435. doi: 10.1016/j.surg.2017.09.027. Epub 2017 Nov 22.
PubMed 29174434Couzi L, Moulin B, Morin MP, Albano L, Godin M, Barrou B, Alamartine E, Morelon E, Girardot-Seguin S, Mendes L, Misdrahi D, Cassuto E, Merville P. Factors predictive of medication nonadherence after renal transplantation: a French observational study. Transplantation. 2013 Jan 27;95(2):326-32. doi: 10.1097/TP.0b013e318271d7c1.
PubMed 23149477Gonzales HM, Fleming JN, Gebregziabher M, Posadas-Salas MA, Su Z, McGillicuddy JW, Taber DJ. Pharmacist-Led Mobile Health Intervention and Transplant Medication Safety: A Randomized Controlled Clinical Trial. Clin J Am Soc Nephrol. 2021 May 8;16(5):776-784. doi: 10.2215/CJN.15911020. Epub 2021 Apr 30.
PubMed 33931415Park S, Guo K, Heilman RL, Poggio ED, Taber DJ, Marsh CL, Kurian SM, Kleiboeker S, Weems J, Holman J, Zhao L, Sinha R, Brietigam S, Rebello C, Abecassis MM, Friedewald JJ. Combining Blood Gene Expression and Cellfree DNA to Diagnose Subclinical Rejection in Kidney Transplant Recipients. Clin J Am Soc Nephrol. 2021 Oct;16(10):1539-1551. doi: 10.2215/CJN.05530421.
PubMed 34620649Kalantar-Zadeh K, Kam-Tao Li P, Tantisattamo E, Kumaraswami L, Liakopoulos V, Lui SF, Ulasi I, Andreoli S, Balducci A, Dupuis S, Harris T, Hradsky A, Knight R, Kumar S, Ng M, Poidevin A, Saadi G, Tong A; World Kidney Day Steering Committee. Living well with kidney disease by patient and care-partner empowerment: kidney health for everyone everywhere. Kidney Int. 2021 Feb;99(2):278-284. doi: 10.1016/j.kint.2020.11.004.
PubMed 33509344Fleming JN, Cober T, Hickey J, Stach L, Kawano A, Szczepanik A, Watson A, Imamura Y, Weems J, West-Thielke P. Clinical Utility of the OmniGraf Biomarker Panel in the Care of Kidney Transplant Recipients (CLARITY): Protocol for a Prospective, Multisite Observational Study. JMIR Res Protoc. 2022 Dec 14;11(12):e41020. doi: 10.2196/41020.
PubMed 36515980
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLinical Utility of the omnigrAf® biomarkeR Panel In The Care of kidneY Transplant Recipients
- ClinicalTrials.gov ID
- NCT05482100
- Acronym / sponsor ID
- CLARITY / TGRP11
- Conditions
- Kidney Transplant Rejection
- Keywords
- Biomarkers, Subclinical Rejection, Immunosuppression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Transplant Genomics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2022 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 1 Aug 2022 (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 a prospective, multi-site, observational study with a matched control group. The primary objective is to evaluate change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM monitoring in conjunction with patient medication-related burden monitoring.
Detailed description
The survival benefits of solid organ transplants in the United States are well documented. Improvements in immunosuppression, better anti-microbial agents, and other aspects of ancillary care have resulted in significant improvements in short- term outcomes; however, there has been little improvement in long-term graft loss. A more recent analysis found that 65% of hospital readmissions in kidney transplant recipients had adverse drug events (ADE) considered contributory, and ADE-associated readmissions had a significantly higher hazard or graft loss and death compared to patients with readmissions not associated with an ADE. Even with knowledge of ADEs, clinicians may be reluctant to adjust immunosuppressive medications due to concerns of rejection risk during the period of medication adjustment. The OmniGrafTM biomarker panel (Transplant Genomics, Inc, Framingham, MA) includes the TruGraf® peripheral blood expression profile and the TRAC donor-derived cell-free DNA(dd-cfDNA) test, which have demonstrated a strong ability to identify immune quiescence in stable patients post kidney transplant, with a NPV of 94% when both tests are negative and a PPV of 89% for subclinical rejection when both tests are positive. Because of the strong "rule out" capabilities of OmniGrafTM, it would be an ideal complement to real-time ADE knowledge to help guide clinicians' decisions to adjust, or not adjust, the immunosuppressive regimen, and help provide a dialogue between patients and clinicians on the risk-benefit of medication adjustments. The aim of this study is to evaluate change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM monitoring in conjunction with patient medication-related burden monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients monitored with OmniGraf Testing | – | Diagnostic Test: Patients monitored with OmniGraf testingSubjects will have OmniGraf™ testing at study enrollment and thereafter every 3 months or at the same time as standard routine labs (minimum two per year). In addition, subjects will have OmniGraf™ testing at any time there is a workup for clinical events and referral to advanced care (transplant center, biopsy, etc) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is an observational study in adult (age ≥ 18 years), kidney transplant patients who are at 3 months to 2 years from the time of transplant. Approximately 500 subjects will be enrolled.
Key inclusion criteria (5 listed)
- Written informed consent and HIPAA authorization;
- At least 18 years of age;
- Recipient of a primary or subsequent deceased-donor or living-donor kidney transplant;
- Between 3 months and 2 years post-transplant;
- Selected by provider to undergo OmniGraf™ testing as part of usual post-transplant care
Key exclusion criteria (7 listed)
- Recipient of a combined organ transplant with an extra-renal organ and/or islet cell transplant;
- Recipient of a previous non-renal solid organ and/or islet cell transplant;
- Known to be pregnant;
- Known to be infected with Human Immunodeficiency Virus (HIV);
- Known to have active BK nephropathy;
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 |
|---|---|---|
| Patients monitored with OmniGraf testingThis is an observational study there are no protocol mandated interventions. OmniGraf results will be utilized in conjunction with standard of care assessments to determine patient management. | Diagnostic test | Patients monitored with OmniGraf Testing |
Primary outcome
GFR changes between study group and matched control group
Time frame: 3 years
Comparison of the slope change in estimated glomerular filtration rate (eGFR), calculated using the MDRD 4-variable equation and CKD-EPI, from baseline to the end of follow-up between study participants and a matched control group.
13 secondary outcomes
PROMISE and Self efficacy results from baseline to study completion
Time frame: 3 years
PROMISE results from baseline to study completion
Time frame: 3 years
PROMIS Depression scale from baseline to study completion
Time frame: 3 years
Comparison of Hospitlizations due to infections in the matched control and study group
Time frame: 3 years
Comparison of rejection of matched control and study group
Time frame: 3 years
MRSB
Time frame: 3 years
Graft survival at 3 years comparison of matched control vs. study group
Time frame: 3 years
Graft survival at 1-2 years comparison of matched control vs. study group
Time frame: 2 years
Graft loss during study period
Time frame: 3 years
Graft survival during study period
Time frame: 3 years
Death-censored graft loss
Time frame: 3 years
Patient death during study period
Time frame: 3 years
Provider changes during study period
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Background: PubMed 21883901Tonelli M, Wiebe N, Knoll G, Bello A, Browne S, Jadhav D, Klarenbach S, Gill J. Systematic review: kidney transplantation compared with dialysis in clinically relevant outcomes. Am J Transplant. 2011 Oct;11(10):2093-109. doi: 10.1111/j.1600-6143.2011.03686.x. Epub 2011 Aug 30.
- Background: PubMed 28236831Saran R, Robinson B, Abbott KC, Agodoa LY, Albertus P, Ayanian J, Balkrishnan R, Bragg-Gresham J, Cao J, Chen JL, Cope E, Dharmarajan S, Dietrich X, Eckard A, Eggers PW, Gaber C, Gillen D, Gipson D, Gu H, Hailpern SM, Hall YN, Han Y, He K, Hebert H, Helmuth M, Herman W, Heung M, Hutton D, Jacobsen SJ, Ji N, Jin Y, Kalantar-Zadeh K, Kapke A, Katz R, Kovesdy CP, Kurtz V, Lavalee D, Li Y, Lu Y, McCullough K, Molnar MZ, Montez-Rath M, Morgenstern H, Mu Q, Mukhopadhyay P, Nallamothu B, Nguyen DV, Norris KC, O'Hare AM, Obi Y, Pearson J, Pisoni R, Plattner B, Port FK, Potukuchi P, Rao P, Ratkowiak K, Ravel V, Ray D, Rhee CM, Schaubel DE, Selewski DT, Shaw S, Shi J, Shieu M, Sim JJ, Song P, Soohoo M, Steffick D, Streja E, Tamura MK, Tentori F, Tilea A, Tong L, Turf M, Wang D, Wang M, Woodside K, Wyncott A, Xin X, Zang W, Zepel L, Zhang S, Zho H, Hirth RA, Shahinian V. US Renal Data System 2016 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2017 Mar;69(3 Suppl 1):A7-A8. doi: 10.1053/j.ajkd.2016.12.004. No abstract available.
- Background: PubMed 26755262Hart A, Smith JM, Skeans MA, Gustafson SK, Stewart DE, Cherikh WS, Wainright JL, Boyle G, Snyder JJ, Kasiske BL, Israni AK. Kidney. Am J Transplant. 2016 Jan;16 Suppl 2(Suppl 2):11-46. doi: 10.1111/ajt.13666.
- Background: PubMed 14961990Meier-Kriesche HU, Schold JD, Srinivas TR, Kaplan B. Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era. Am J Transplant. 2004 Mar;4(3):378-83. doi: 10.1111/j.1600-6143.2004.00332.x.
- Background: PubMed 35266618Lentine KL, Smith JM, Hart A, Miller J, Skeans MA, Larkin L, Robinson A, Gauntt K, Israni AK, Hirose R, Snyder JJ. OPTN/SRTR 2020 Annual Data Report: Kidney. Am J Transplant. 2022 Mar;22 Suppl 2:21-136. doi: 10.1111/ajt.16982.
- Background: PubMed 19191769El-Zoghby ZM, Stegall MD, Lager DJ, Kremers WK, Amer H, Gloor JM, Cosio FG. Identifying specific causes of kidney allograft loss. Am J Transplant. 2009 Mar;9(3):527-35. doi: 10.1111/j.1600-6143.2008.02519.x. Epub 2008 Feb 3.
- Background: PubMed 29174434Arms MA, Fleming J, Sangani DB, Nadig SN, McGillicuddy JW, Taber DJ. Incidence and impact of adverse drug events contributing to hospital readmissions in kidney transplant recipients. Surgery. 2018 Feb;163(2):430-435. doi: 10.1016/j.surg.2017.09.027. Epub 2017 Nov 22.
- Background: PubMed 23149477Couzi L, Moulin B, Morin MP, Albano L, Godin M, Barrou B, Alamartine E, Morelon E, Girardot-Seguin S, Mendes L, Misdrahi D, Cassuto E, Merville P. Factors predictive of medication nonadherence after renal transplantation: a French observational study. Transplantation. 2013 Jan 27;95(2):326-32. doi: 10.1097/TP.0b013e318271d7c1.
- Background: PubMed 33931415Gonzales HM, Fleming JN, Gebregziabher M, Posadas-Salas MA, Su Z, McGillicuddy JW, Taber DJ. Pharmacist-Led Mobile Health Intervention and Transplant Medication Safety: A Randomized Controlled Clinical Trial. Clin J Am Soc Nephrol. 2021 May 8;16(5):776-784. doi: 10.2215/CJN.15911020. Epub 2021 Apr 30.
- Background: PubMed 34620649Park S, Guo K, Heilman RL, Poggio ED, Taber DJ, Marsh CL, Kurian SM, Kleiboeker S, Weems J, Holman J, Zhao L, Sinha R, Brietigam S, Rebello C, Abecassis MM, Friedewald JJ. Combining Blood Gene Expression and Cellfree DNA to Diagnose Subclinical Rejection in Kidney Transplant Recipients. Clin J Am Soc Nephrol. 2021 Oct;16(10):1539-1551. doi: 10.2215/CJN.05530421.
- Background: PubMed 33509344Kalantar-Zadeh K, Kam-Tao Li P, Tantisattamo E, Kumaraswami L, Liakopoulos V, Lui SF, Ulasi I, Andreoli S, Balducci A, Dupuis S, Harris T, Hradsky A, Knight R, Kumar S, Ng M, Poidevin A, Saadi G, Tong A; World Kidney Day Steering Committee. Living well with kidney disease by patient and care-partner empowerment: kidney health for everyone everywhere. Kidney Int. 2021 Feb;99(2):278-284. doi: 10.1016/j.kint.2020.11.004.
- Derived from this study: PubMed 36515980Fleming JN, Cober T, Hickey J, Stach L, Kawano A, Szczepanik A, Watson A, Imamura Y, Weems J, West-Thielke P. Clinical Utility of the OmniGraf Biomarker Panel in the Care of Kidney Transplant Recipients (CLARITY): Protocol for a Prospective, Multisite Observational Study. JMIR Res Protoc. 2022 Dec 14;11(12):e41020. doi: 10.2196/41020.
- Individual participant dataSharing planned: No
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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.
James Fleming, PharmD contact
Patty West-Thielke, PharmD study director
Transplant Genomics
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Rejection, run by Transplant Genomics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. 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 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Isioma Agboli, MD (15107678609, isiomaagboli@eurofins-tgi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GFR changes between study group and matched control group (time frame: 3 years). 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 NCT05482100, which also lists 12 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 1 Aug 2022.