Kidney Transplant; ComplicationsNCT04280276
TruGraf Utilization in High IPV Levels
A study testing TruGraf test in people with Kidney Transplant; Complications, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Intra-patient variability (IPV) in tacrolimus is associated with premature graft loss. The rate of acute rejection episodes is higher in these patients, and acute rejection impacts negatively on graft survival. The prevalence of patients with high IPV is higher in African American patients (1-5). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant; Complications
- What is being tested?
- TruGraf test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2020to 1 Mar 2022
- 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
Inclusion Criteria: Patients who meet all of the following criteria are eligible for enrollment:
- Are 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 or subsequent deceased-donor or living donor kidney transplantation.
- Stable serum creatinine (current serum creatinine <2.3 mg/dl, <20% increase compared to the average of the previous 3 serum creatinine levels)
- Kidney transplant patients who >90 days (+/- 2 weeks) post-transplant will be included in this study
- Patients with at least 3 tacrolimus trough levels( deemed as appropriately 12-hour trough levels) within 3-36 months post-transplant
Exclusion Criteria: Patients who meet any of these criteria are not eligible for enrollment:
- Inability or unwillingness to provide informed consent.
- Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
- Recipients of previous non-renal solid organ and/or islet cell transplantation.
- Infection with HIV.
- Infection with BK nephropathy.
- Patients that have nephrotic range proteinuria (urine protein >3 gm/day).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Utilizing TruGraf Testing in Recipients of Kidney Transplantation With High Intra-patient Variability in Tacrolimus Exposure: A Pilot Study
Intra-patient variability (IPV) in tacrolimus is associated with premature graft loss. The rate of acute rejection episodes is higher in these patients, and acute rejection impacts negatively on graft survival. The prevalence of patients with high IPV is higher in African American patients (1-5). At the kidney transplant program of the University of Maryland, our investigators follow over 2.800 patients, with approximately 50% of the patients being of African American heritage, thus an ideal setting for the study.
Read the detailed description
Study Population: Kidney transplant recipients with stable renal function with regular follow-up at the University of Maryland post-transplant clinic with at least 3 levels deemed as appropriately 12-hour trough levels within 3-36 months post-transplant.
Group 1 - patients with high IPV (designated as ≥ 30%). Group 2 - patients with normal IPV (< 30%). Will assess risk of subclinical acute rejection in patients with high IPV compared to normal IPV. All tacrolimus 12 h trough levels in patients with stable allograft function at least 3 months post-transplant.
Calculation of IPV: CV (%) = (SD/mean Tac trough concentration) x 100 (if stable total daily dose). To take into account dose changes, obtained levels will be corrected for the corresponding daily dose of tacrolimus to help correctly calculate IPV (CV C0/D-IPV) (6-7).
Patients will be tested with TruGraf one time during the study.
- Conditions
- Kidney Transplant; Complications
- Being tested
- TruGraf test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruGraf testDiagnostic test
To obtain longitudinal TruGraf testing in patients with stable creatinine, high and normal IPV in tacrolimus levels, between 3 and 18 months post-transplant at the University of Maryland post-transplant clinic.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Patients with high IPV (designated as ≥ 30%). | Active comparator | Patients with high IPV (designated as ≥ 30%). Receives: Diagnostic Test: TruGraf test |
| Group 2 - patients with normal IPV (< 30%). | Active comparator | Patients with normal IPV (< 30%). Will assess risk of subclinical acute rejection in patients with high IPV compared to normal IPV. All tacrolimus 12 h trough levels in patients with stable allograft function at least 3 months post-transplant. Receives: Diagnostic Test: TruGraf test |
What is being measured
The primary outcome is the main question the study is designed to answer.
TruGraf test validity on immunosuppression damage
The TruGraf test is a non-invasive blood test that measures molecular gene expression profiles associated with clinical conditions previously only diagnosed by biopsy in kidney transplant recipients. The results of the TruGraf test provide additional information about the adequacy of immunosuppression and may be used to support decisions in patient management.
Measured: up to 18 months post-transplant
Secondary outcomes (1)
Renal function associated with premature graft loss
Utilization of TruGraf testing in patients with stable creatinine, high and normal intrapatient variability (IPV) in tacrolimus levels, between 3 and 18 months post-transplant. This information will aid in determining if local practices should be updated for patient care
Measured: up to 18 months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start2 Mar 2020
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Why it stopped: Sponsor, TGI, was acquired by Eurofins Inc. New owner requested all IIT's be terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Transplant Genomics, Inc.
- Responsible party
- Principal investigator, Roberto Kalil, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280276
- Sponsor's protocol ID
- HP-00089343
- Status last verified
- Dec 2024
- First submitted
- 11 Feb 2020
- Last updated
- 16 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing TruGraf Testing in Recipients of Kidney Transplantation With High Intra-patient Variability in Tacrolimus Exposure: A Pilot Study
- ClinicalTrials.gov ID
- NCT04280276
- Acronym / sponsor ID
- HP-00089343
- Conditions
- Kidney Transplant; Complications
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor, TGI, was acquired by Eurofins Inc. New owner requested all IIT's be terminated.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Transplant Genomics, Inc.
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 21 Feb 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.
Intra-patient variability (IPV) in tacrolimus is associated with premature graft loss. The rate of acute rejection episodes is higher in these patients, and acute rejection impacts negatively on graft survival. The prevalence of patients with high IPV is higher in African American patients (1-5). At the kidney transplant program of the University of Maryland, our investigators follow over 2.800 patients, with approximately 50% of the patients being of African American heritage, thus an ideal setting for the study.
Detailed description
Study Population: Kidney transplant recipients with stable renal function with regular follow-up at the University of Maryland post-transplant clinic with at least 3 levels deemed as appropriately 12-hour trough levels within 3-36 months post-transplant.
Group 1 - patients with high IPV (designated as ≥ 30%). Group 2 - patients with normal IPV (< 30%). Will assess risk of subclinical acute rejection in patients with high IPV compared to normal IPV. All tacrolimus 12 h trough levels in patients with stable allograft function at least 3 months post-transplant.
Calculation of IPV: CV (%) = (SD/mean Tac trough concentration) x 100 (if stable total daily dose). To take into account dose changes, obtained levels will be corrected for the corresponding daily dose of tacrolimus to help correctly calculate IPV (CV C0/D-IPV) (6-7).
Patients will be tested with TruGraf one time during the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Patients with high IPV (designated as ≥ 30%). | Active comparator | Diagnostic Test: TruGraf testPatients with high IPV (designated as ≥ 30%). |
| Group 2 - patients with normal IPV (< 30%). | Active comparator | Diagnostic Test: TruGraf testPatients with normal IPV (< 30%). Will assess risk of subclinical acute rejection in patients with high IPV compared to normal IPV. All tacrolimus 12 h trough levels in patients with stable allograft function at least 3 months post-transplant. |
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 |
|---|---|---|
| TruGraf testTo obtain longitudinal TruGraf testing in patients with stable creatinine, high and normal IPV in tacrolimus levels, between 3 and 18 months post-transplant at the University of Maryland post-transplant clinic. | Diagnostic test | Group 1 - Patients with high IPV (designated as ≥ 30%)., Group 2 - patients with normal IPV (< 30%). |
Primary outcome
TruGraf test validity on immunosuppression damage
Time frame: up to 18 months post-transplant
The TruGraf test is a non-invasive blood test that measures molecular gene expression profiles associated with clinical conditions previously only diagnosed by biopsy in kidney transplant recipients. The results of the TruGraf test provide additional information about the adequacy of immunosuppression and may be used to support decisions in patient management.
1 secondary outcome
Renal function associated with premature graft loss
Time frame: up to 18 months post-transplant
Results and safety
The study was stopped early (reason given: Sponsor, TGI, was acquired by Eurofins Inc. New owner requested all IIT's be terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Kidney Transplant; Complications
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingEarly Phase 1
Fecal Microbiota Transplantation in Kidney Stone Patients
Kidney Stones, Urinary Stone Disease / Nephrolithiasis
Not yet recruitingPhase 3
To Assess the Efficacy and Safety of Pegcetacoplan for the Prevention of Recurrent C3G or Primary IC-MPGN in Kidney Transplant Recipients
C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
RecruitingObservational study
The KidneyCARE (Community Access to Research Equity) Study
Chronic Kidney Disease, Dialysis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 test in people with Kidney Transplant; Complications, run by University of Maryland, Baltimore 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: stopped early, as of the sponsor's last update on 16 Dec 2024. 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?
The study was stopped early (reason given: Sponsor, TGI, was acquired by Eurofins Inc. New owner requested all IIT's be terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TruGraf test validity on immunosuppression damage (time frame: up to 18 months post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2024.