Transplant Recipient (Kidney)NCT07815938
Immune Monitoring-Guided Individualized Tacrolimus Therapy in Renal Transplant Recipients: An Observational Study and PK/PD Modeling
An observational study of Transplant Recipient (Kidney), run by Zhongnan Hospital.
Trial summary
This study aims to resolve the clinical limitation that therapeutic drug monitoring (TDM) alone cannot accurately reflect the net immune status after kidney transplantation. Within 12 months post-transplantation, we will systematically characterize dynamic trajectories of biomarkers including TTV DNA load, lymphocyte… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant Recipient (Kidney)
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients receiving primary allogeneic kidney transplantation
Who may be able to join
- Aged 18-65 years, no gender restriction.
- Patients receiving primary allogeneic kidney transplantation.
- Maintenance immunosuppressive regimen based on tacrolimus after transplantation, with complete records of tacrolimus dosage, administration time and therapeutic drug monitoring data available.
- Expected follow-up duration of at least 12 months at this center, and ability to complete scheduled blood and urine sample collection.
- Subjects who fully understand the study protocol with good compliance, and provide written informed consent.
Who cannot join
- Combined multi-organ transplantation (e.g., combined liver-kidney transplantation).
- ABO-incompatible transplantation or patients with high preformed donor-specific antibody (DSA) titers requiring special induction regimens due to high immunological risk.
- Patients with active HIV, HCV or HBV infection, or preoperative severe active infection requiring systematic anti-infective therapy.
- Patients with delayed graft function or graft loss within 1 week after surgery.
- Patients with severe hepatic or renal dysfunction.
- Participants enrolled in other interventional clinical trials.
- Pregnant or breastfeeding women.
- Other conditions judged inappropriate for study participation by investigators.
About this study
This study aims to resolve the clinical limitation that therapeutic drug monitoring (TDM) alone cannot accurately reflect the net immune status after kidney transplantation. Within 12 months post-transplantation, we will systematically characterize dynamic trajectories of biomarkers including TTV DNA load, lymphocyte subsets and cytokines, and quantify their correlations with BK virus infection (over-immunosuppression) and acute rejection (insufficient immunosuppression). By integrating tacrolimus pharmacokinetics (PK), pharmacogenomics and immune monitoring indicators, a population pharmacokinetic-pharmacodynamic (PopPK/PD) model will be established to provide evidence supporting the paradigm shift from concentration-based dosing to immune effect-guided precision dosing.
- Conditions
- Transplant Recipient (Kidney)
- Being tested
- No interventional treatment, only observational data collection without clinical drug adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventional treatment, only observational data collection without clinical drug adjustmentOther
No interventional treatment, only observational data collection without clinical drug adjustment
What is being measured
The primary outcome is the main question the study is designed to answer.
Tacrolimus trough blood concentration
Measured: Routine follow-up time points within 12 months after kidney transplantation (1 week, 2 weeks, 1 month, monthly from 2 to 12 months post-operation)
Secondary outcomes (2)
Immune monitoring biomarkers (TTV DNA load, lymphocyte subsets, cytokines)
Measured: Collected simultaneously with tacrolimus sampling at all follow-up visits within 12 months post-transplantation
BK virus infection, acute cellular rejection
Measured: Recorded and confirmed on the day of event occurrence during 12-month full follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant Recipient (Kidney)Studies 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
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815938
- Sponsor's protocol ID
- 2026018k
- Other IDs
- 82574502
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Monitoring-Guided Individualized Tacrolimus Therapy in Renal Transplant Recipients: An Observational Study and PK/PD Modeling
- ClinicalTrials.gov ID
- NCT07815938
- Acronym / sponsor ID
- 2026018k
- Conditions
- Transplant Recipient (Kidney)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Collaborators
- Fudan University
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Sep 2026 (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 study aims to resolve the clinical limitation that therapeutic drug monitoring (TDM) alone cannot accurately reflect the net immune status after kidney transplantation. Within 12 months post-transplantation, we will systematically characterize dynamic trajectories of biomarkers including TTV DNA load, lymphocyte subsets and cytokines, and quantify their correlations with BK virus infection (over-immunosuppression) and acute rejection (insufficient immunosuppression). By integrating tacrolimus pharmacokinetics (PK), pharmacogenomics and immune monitoring indicators, a population pharmacokinetic-pharmacodynamic (PopPK/PD) model will be established to provide evidence supporting the paradigm shift from concentration-based dosing to immune effect-guided precision dosing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving primary allogeneic kidney transplantation
Key inclusion criteria (5 listed)
- Aged 18-65 years, no gender restriction.
- Patients receiving primary allogeneic kidney transplantation.
- Maintenance immunosuppressive regimen based on tacrolimus after transplantation, with complete records of tacrolimus dosage, administration time and therapeutic drug monitoring data available.
- Expected follow-up duration of at least 12 months at this center, and ability to complete scheduled blood and urine sample collection.
- Subjects who fully understand the study protocol with good compliance, and provide written informed consent.
Key exclusion criteria (8 listed)
- Combined multi-organ transplantation (e.g., combined liver-kidney transplantation).
- ABO-incompatible transplantation or patients with high preformed donor-specific antibody (DSA) titers requiring special induction regimens due to high immunological risk.
- Patients with active HIV, HCV or HBV infection, or preoperative severe active infection requiring systematic anti-infective therapy.
- Patients with delayed graft function or graft loss within 1 week after surgery.
- Patients with severe hepatic or renal dysfunction.
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 |
|---|---|---|
| No interventional treatment, only observational data collection without clinical drug adjustmentNo interventional treatment, only observational data collection without clinical drug adjustment | Other | – |
Primary outcome
Tacrolimus trough blood concentration
Time frame: Routine follow-up time points within 12 months after kidney transplantation (1 week, 2 weeks, 1 month, monthly from 2 to 12 months post-operation)
2 secondary outcomes
Immune monitoring biomarkers (TTV DNA load, lymphocyte subsets, cytokines)
Time frame: Collected simultaneously with tacrolimus sampling at all follow-up visits within 12 months post-transplantation
BK virus infection, acute cellular rejection
Time frame: Recorded and confirmed on the day of event occurrence during 12-month full follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant Recipient (Kidney), run by Zhongnan Hospital.
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 8 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: opening soon, as of the sponsor's last update on 11 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Tacrolimus trough blood concentration (time frame: Routine follow-up time points within 12 months after kidney transplantation (1 week, 2 weeks, 1 month, monthly from 2 to 12 months post-operation)). 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 11 Sep 2026.