Kidney TransplantTARGETNCT06833463
Tacrolimus and Risk Factors for Glucose Metabolism Disorders in Kidney Transplant Patients
An observational study of Kidney Transplant, run by Chiesi Poland Sp. z o.o. at 6 sites in Poland.
Trial summary
Many people who receive a kidney transplant develop problems with how their body processes sugar (glucose). This includes conditions like prediabetes and diabetes, which can lead to more health issues, such as heart problems and infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- LCP Tacro (tacrolimus)
- How many people
- 120 participants
- Where
- 6 sitesPoland
- Study dates
- 29 May 2025to 30 Jan 2028
- 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: Adult kidney graft receipients transplanted in the participating study sites
Who may be able to join
- Age ≥ 18 years
- Recipients of a kidney transplant from a living or deceased donor
- Standard immunosuppressive regimen post-kidney transplantation (KTx) including Envarsus®
- LCP Tacrolimus therapy initiated from the day of KTx or conversion from another tacrolimus formulation to LCP Tacrolimus by day 8 at the latest, according to the institution's routine practice
- Informed patient consent to participate in the study
Who cannot join
- Diagnosis of diabetes (type 1 or type 2) treated with diet or glucose-lowering drugs
- Random glycemia/HbA1c levels justifying a diagnosis of diabetes at the time of study enrollment
- Kidney retransplantation
- Recipients of a multi-organ transplant
- Use of glucagon-like peptide-1 (GLP-1) receptor agonists for weight loss
- Use of flozins for renal or cardiac indications
- Chronic use of drugs affecting carbohydrate metabolism, such as glucocorticosteroids
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tomasz Dębowski, MD, PhD contact
6 sites in 1 country
Poland6 sites, 6 recruiting
- Recruiting
Department of Nephrology, Transplantology and Internal Diseases, Medical University of Gdansk
Gdansk, 80-952
Alicja Dębska-Ślizień, Professor, +48 58 584 4700, adeb@gumed.edu.pl
- Recruiting
Clinical Department of Nephrology, Dialysis, Transplantology and Internal Medicine
Krakow, 30-688
Katarzyna Krzanowska, Professor, +48 12 400 28 50, kasiakrzanowska@op.pl
- Not yet recruiting
Department of Internal Diseases and Transplant Nephrology, Medical University of Lodz
Lodz, 90-153
Ilona Kurnatowska, Professor, +48 42 291 95 97, kuril@wp.pl
- Recruiting
Department of Transplantology and General Surgery, Provincial Hospital
Poznan, 60-479
Maciej Głyda, Professor, +48 61 821 22 27, glydam@wp.pl
- Not yet recruiting
Department and Clinic of Nephrology, Dialysis and Internal Medicine, Medical University of Warsaw
Warsaw, 02-097
Jolanta Małyszko, Professor, +48 22 599 26 58, jmalyszko@wum.edu.pl
- Recruiting
Department and Clinic of Nephrology and Transplantation Medicine, University Clinical Hospital
Wroclaw, 50-556
Mirosław Banasik, Professor, +48 71 733 25 00, m.banasik@interia.pl
About this study
Many people who receive a kidney transplant develop problems with how their body processes sugar (glucose). This includes conditions like prediabetes and diabetes, which can lead to more health issues, such as heart problems and infections.
One of the main medications used after a kidney transplant, called tacrolimus, can contribute to these sugar problems. Tacrolimus helps protect the new kidney, but it can also harm the cells in the pancreas that produce insulin, a hormone that controls blood sugar. Other factors, such as stress on the body and insulin resistance, can make things worse.
Read more
The effect of tacrolimus on blood sugar may depend on how the body processes the drug. Some people break down tacrolimus quickly (fast metabolizers), so they need higher doses to reach the right level in their blood. Others break it down more slowly (slow metabolizers) and require lower doses. Doctors can measure how fast someone metabolizes tacrolimus using aparameter called the concentration-to-dose (C/D) ratio.
This study aims to find out what increases the risk of developing blood sugar problems after a kidney transplant. It will focus on how quickly patients process tacrolimus and whether this affects their risk of developing diabetes. The study will also look at how common these issues are in kidney transplant patients in Poland.
- Conditions
- Kidney Transplant
- Being tested
- LCP Tacro (tacrolimus)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCP Tacro (tacrolimus)Drug
Treatment with LCP Tacro will begin on the day of the kidney transplant. If a patient is switching from another form of tacrolimus to LCP Tacro, the transition will be completed no later than day 8, following the standard procedures of the medical institution.
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose metabolism disorders during tacrolimus treatment
Percentage of patients diagnosed with:
- Impaired fasting glucose and/or glucose intolerance (prediabetes)
- Post-transplant diabetes mellitus (PTDM) requiring pharmacotherapy,
Measured: The endpoint will be determined at 3, 6, and 12 months after transplantation
Risk factors for glucose metabolism disorders
Odds ratio for glucose metabolism disorders (prediabetes, PTDM) for the following variables: the rate of tacrolimus metabolism, cumulative tacrolimus exposure, cumulative glicocorticosteroid exposure, age, sex, body mass index
Measured: 3, 6, and 12 months after transplantation
Secondary outcomes (1)
Fasting glucose
Changes in mean fasting glucose levels
Measured: over a period of 1-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start29 May 2025
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi Poland Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alicja Dębska-Ślizień, Professor, Principal investigator, Department of Nephrology, Transplantology and Internal Diseases, Medical University of Gdansk, Gdansk, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833463
- Sponsor's protocol ID
- CHI-PL-ENV-03
- Acronym
- TARGET
- Status last verified
- Apr 2026
- First submitted
- 13 Feb 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tacrolimus and Risk Factors for Glucose Metabolism Disorders in Kidney Transplant Patients
- ClinicalTrials.gov ID
- NCT06833463
- Acronym / sponsor ID
- TARGET / CHI-PL-ENV-03
- Conditions
- Kidney Transplant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chiesi Poland Sp. z o.o.Industry (pharma, biotech, devices)
- Study start
- 29 May 2025 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 18 Feb 2025 (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.
Many people who receive a kidney transplant develop problems with how their body processes sugar (glucose). This includes conditions like prediabetes and diabetes, which can lead to more health issues, such as heart problems and infections.
One of the main medications used after a kidney transplant, called tacrolimus, can contribute to these sugar problems. Tacrolimus helps protect the new kidney, but it can also harm the cells in the pancreas that produce insulin, a hormone that controls blood sugar. Other factors, such as stress on the body and insulin resistance, can make things worse.
The effect of tacrolimus on blood sugar may depend on how the body processes the drug. Some people break down tacrolimus quickly (fast metabolizers), so they need higher doses to reach the right level in their blood. Others break it down more slowly (slow metabolizers) and require lower doses. Doctors can measure how fast someone metabolizes tacrolimus using aparameter called the concentration-to-dose (C/D) ratio.
This study aims to find out what increases the risk of developing blood sugar problems after a kidney transplant. It will focus on how quickly patients process tacrolimus and whether this affects their risk of developing diabetes. The study will also look at how common these issues are in kidney transplant patients in Poland.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult kidney graft receipients transplanted in the participating study sites
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Recipients of a kidney transplant from a living or deceased donor
- Standard immunosuppressive regimen post-kidney transplantation (KTx) including Envarsus®
- LCP Tacrolimus therapy initiated from the day of KTx or conversion from another tacrolimus formulation to LCP Tacrolimus by day 8 at the latest, according to the institution's routine practice
- Informed patient consent to participate in the study
Key exclusion criteria (7 listed)
- Diagnosis of diabetes (type 1 or type 2) treated with diet or glucose-lowering drugs
- Random glycemia/HbA1c levels justifying a diagnosis of diabetes at the time of study enrollment
- Kidney retransplantation
- Recipients of a multi-organ transplant
- Use of glucagon-like peptide-1 (GLP-1) receptor agonists for weight loss
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 |
|---|---|---|
| LCP Tacro (tacrolimus)Treatment with LCP Tacro will begin on the day of the kidney transplant. If a patient is switching from another form of tacrolimus to LCP Tacro, the transition will be completed no later than day 8, following the standard procedures of the medical institution. | Drug | – |
Primary outcome
Glucose metabolism disorders during tacrolimus treatment
Time frame: The endpoint will be determined at 3, 6, and 12 months after transplantation
Percentage of patients diagnosed with: * Impaired fasting glucose and/or glucose intolerance (prediabetes) * Post-transplant diabetes mellitus (PTDM) requiring pharmacotherapy,
Risk factors for glucose metabolism disorders
Time frame: 3, 6, and 12 months after transplantation
Odds ratio for glucose metabolism disorders (prediabetes, PTDM) for the following variables: the rate of tacrolimus metabolism, cumulative tacrolimus exposure, cumulative glicocorticosteroid exposure, age, sex, body mass index
1 secondary outcome
Fasting glucose
Time frame: over a period of 1-12 months
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 2 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Kidney Transplant
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Hypothermic Kidney Machine Perfusion With Omnisol
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Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
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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.
Tomasz Dębowski, MD, PhD contact
Alicja Dębska-Ślizień, Professor principal investigator
Department of Nephrology, Transplantology and Internal Diseases, Medical University of Gdansk, Gdansk, Poland
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant, run by Chiesi Poland Sp. z o.o. at 6 sites in Poland.
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: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Poland. 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?
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?
Contact Roman Hożejowski, MD (+48 22 620 14 21, r.hozejowski@chiesi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose metabolism disorders during tacrolimus treatment (time frame: The endpoint will be determined at 3, 6, and 12 months after transplantation). The study lists 2 primary outcomes in all. 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 2 Apr 2026.