Kidney TransplantationPITONNCT07884084
Effect of Probiotics on Immunosuppressant Therapy in Kidney Transplant Recipients
A study testing Probiotic formulation in people with Kidney Transplantation and Kidney Transplantation Recipients, run by Federico II University at 1 site in Italy.
Trial summary
People who receive a donor kidney must take drugs to prevent their bodies from attacking the new organ. These drugs are called immunosuppressants. Probiotics are beneficial microbes that support gut health. They are often given to reduce immunosuppressant toxicity for the gut. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplantation, Kidney Transplantation Recipients
- What is being tested?
- Probiotic formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jun 2025to 3 Oct 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- kidney transplant at least 12 months prior to enrollment
- No episodes of rejection in the 6 months prior to enrollment
- Immunosuppressive therapy with (in various combinations) corticosteroids, cyclosporine, tacrolimus, sirolimus, everolimus, or mycophenolic acid at stable doses that do not require further adjustments
Who cannot join
- Acute transplant rejection
- Acute or chronic bacterial or fungal infections
- Gastrointestinal resections
- Intensive care unit admission
- Recent (within the last 6 months) major surgeries
- Malabsorption syndromes
Show all 11Show fewer
- Enteral or parenteral nutrition
- Metastatic cancer or systemic chemotherapy
- Terminal illnesses
- Severe cognitive impairments that may reduce adherence to treatment
- Acquired or congenital immunodeficiencies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotics for Immunosuppressant Therapy Optimization
People who receive a donor kidney must take drugs to prevent their bodies from attacking the new organ. These drugs are called immunosuppressants. Probiotics are beneficial microbes that support gut health. They are often given to reduce immunosuppressant toxicity for the gut. The goal of this clinical trial is to learn if probiotics change the levels of immunosuppressants in the blood in patients who have received a kidney transplant.
The main question it aims to answer is:
Read more
- Does a short-term treatment with a probiotic mixture change the circulating levels of the immunosuppressant drugs cyclosporine A, tacrolimus, sirolimus, everolimus, mycophenolic acid, mycophenolate mofetil, and prednisolone? In addition, researchers will also see if probiotics reduce systemic inflammation or ameliorate renal function.
Study participants will be patients with kidney transplant. At different times, each participant will take either probiotics or look-alike capsules with no probiotics. Researchers will compare the levels of immunosuppressant in the blood when participants take the probiotics with those when they take the capsules with no microbes.
Study participants will have to:
- Take oral capsules containing a probiotc mixture for one month and look-alike capsules with no probiotics for another month with a one-month interval between these two treatments;
- Go to the hospital every 30 days for three months for the collection of blood samples;
- Collect feces specimens for microbiome analysis every 30 days for three months and bring them to the hospital.
- Being tested
- Probiotic formulation, Placebo
- Keywords
- kidney transplantation, immunosuppressant drugs, Cyclosporin A, Tacrolimus, Mycophenolic Acid, everolimus, prednisolone, sirolimus, probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic formulationOther
A multistrain probiotic mixture, formulated in capsules for oral administration, containing L. plantarum, L. rhamnosus, L. acidophilus, L. casei, S. thermophilus, B. lactis and an extract of the plant Boswellia serrata. Capsules also contain microcrystalline cellulose, soy lecithin and magnesium dioxide as excipients.
PlaceboOther
Placebo capsules contain only the excipients found in the probiotic preparation (microcrystalline cellulose, soy lecithin and magnesium dioxide). They are indistinguishable from probiotic capsules.
| Study group | Role | What they receive |
|---|---|---|
| Placebo first | Experimental | Patients first receive a placebo, followed by probiotics after a washout period Receives: Other: Probiotic formulation; Other: Placebo |
| probiotic first | Experimental | Patients first receive probiotic, followed by placebo after a washout period Receives: Other: Probiotic formulation; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in immunosuppressant drug blood levels
Cyclosporin A, tacrolimus and sirolimus will be measured using CMIA (Chemiluminescent Microparticle Immunoassay); everolimus using QMS (Quantitative Microsphere System); mycophenolic acid using CEDIA (Cloned Enzyme Donor Immunoassay); and prednisolone using ELISA (Enzyme-Linked Immunosorbent Assay).
Measured: Immunosuppressant blood levels will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Secondary outcomes (15)
Changes in the blood levels of high-sensitivity C-reactive protein (hsCRP)
High-sensitivity C-reactive protein (hsCRP) will be measured in mg/L using ELISA (Enzyme-Linked ImmunoSorbent Assay).
Measured: High-sensitivity C-reactive protein (hsCRP) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Changes in the blood levels of interleukin-1β (IL-1β)
Interleukin-1β (IL-1β) will be measured in ng/L using ELISA (Enzyme-Linked ImmunoSorbent Assay).
Measured: Interleukin-1β (IL-1β) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Changes in the blood levels of interleukin-6 (IL-6)
Interleukin-6 (IL-6) will be measured in ng/L using ELISA (Enzyme-Linked ImmunoSorbent Assay).
Measured: Interleukin-1β (IL-1β) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Changes in the blood levels of tumor necrosis factor-α (TNF-α)
Tumor necrosis factor-α (TNF-α) will be measured in ng/L using ELISA (Enzyme-Linked ImmunoSorbent Assay).
Measured: Tumor necrosis factor-α (TNF-α) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Changes in the blood urea nitrogen (BUN)
Blood urea nitrogen (BUN) will be measured in mg/dL using a standard clinical chemistry analyzer.
Measured: BUN will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Changes in serum creatinine
Serum creatinine will be measured in mg/dL using a standard clinical chemistry analyzer.
Measured: Serum creatinine will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Changes in Estimated Glomerular Filtration Rate (eGFR)
eGFR will be measured in ml/min using a standard clinical chemistry analyzer.
Measured: eGFR will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Body weight
Body weight in Kg will be measured using a professional medical scale.
Measured: Body weight will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period
Body Mass Index (BMI)
Body Mass Index (BMI) will be calculated as the ratio of body weight to the square of height.
Measured: Body Mass Index (BMI) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Waist circumference
Waist circumference in cm will be measured using a tape measure.
Measured: Waist circumference will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Total body water
Total body water in Liters will be measured using Bioelectrical Impedance Analysis (BIA).
Measured: Total body water will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Extracellular water
Extracellular water in Liters will be measured using Bioelectrical Impedance Analysis (BIA).
Measured: Extracellular water will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Fat Mass (FM)
Fat Mass (FM) in Kg will be measured using Bioelectrical Impedance Analysis (BIA).
Measured: Fat Mass (FM) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Fat Free Mass (FFM)
Fat Free Mass (FFM) in Kg will be measured using Bioelectrical Impedance Analysis (BIA).
Measured: Fat Free Mass (FFM) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Phase Angle (PhA)
Phase Angle (PhA) will be calculated using the resistance and reactance values measured with BIA.
Measured: Phase Angle (PhA) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start18 Jun 2025
- Primary completion3 Oct 2025
- Study completion3 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Cataldi, Federico II University
- Investigators
- Mauro Cataldi, MD, PhD, Principal investigator, Federico II University of Naples, ITALY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884084
- Sponsor's protocol ID
- 96/2023 prot. 15107 28/3/2023
- Other IDs
- PNRR-MAD-2022-12376812
- Acronym
- PITON
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huang HW, Chen MJ. Exploring the Preventive and Therapeutic Mechanisms of Probiotics in Chronic Kidney Disease through the Gut-Kidney Axis. J Agric Food Chem. 2024 Apr 17;72(15):8347-8364. doi: 10.1021/acs.jafc.4c00263. Epub 2024 Apr 4.
PubMed 38571475Chung S, Barnes JL, Astroth KS. Gastrointestinal Microbiota in Patients with Chronic Kidney Disease: A Systematic Review. Adv Nutr. 2019 Sep 1;10(5):888-901. doi: 10.1093/advances/nmz028.
PubMed 31165878Chen Z, Chang X, Ye Q, Gao Y, Deng R. Kidney transplantation and gut microbiota. Clin Kidney J. 2024 Aug 14;17(8):sfae214. doi: 10.1093/ckj/sfae214. eCollection 2024 Aug.
PubMed 39170931Di Renzo T, Reale A, Nazzaro S, Iovanna D, Evangelista D, Gautam V, Guida B, Carrano R, Cataldi M. Impact of Probiotics, Prebiotics and Synbiotics Supplementation in Chronic Kidney Disease: A Comprehensive Review of Clinical Trials. Nutrients. 2026 Apr 8;18(8):1176. doi: 10.3390/nu18081176.
PubMed 42074989Manes A, Di Renzo T, Dodani L, Reale A, Gautiero C, Di Lauro M, Nasti G, Manco F, Muscariello E, Guida B, Tarantino G, Cataldi M. Pharmacomicrobiomics of Classical Immunosuppressant Drugs: A Systematic Review. Biomedicines. 2023 Sep 18;11(9):2562. doi: 10.3390/biomedicines11092562.
PubMed 37761003
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics for Immunosuppressant Therapy Optimization
- ClinicalTrials.gov ID
- NCT07884084
- Acronym / sponsor ID
- PITON / 96/2023 prot. 15107 28/3/2023
- Keywords
- kidney transplantation, immunosuppressant drugs, Cyclosporin A, Tacrolimus, Mycophenolic Acid, everolimus, prednisolone, sirolimus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 3 Oct 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 20 Oct 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.
People who receive a donor kidney must take drugs to prevent their bodies from attacking the new organ. These drugs are called immunosuppressants. Probiotics are beneficial microbes that support gut health. They are often given to reduce immunosuppressant toxicity for the gut. The goal of this clinical trial is to learn if probiotics change the levels of immunosuppressants in the blood in patients who have received a kidney transplant.
The main question it aims to answer is:
- Does a short-term treatment with a probiotic mixture change the circulating levels of the immunosuppressant drugs cyclosporine A, tacrolimus, sirolimus, everolimus, mycophenolic acid, mycophenolate mofetil, and prednisolone? In addition, researchers will also see if probiotics reduce systemic inflammation or ameliorate renal function.
Study participants will be patients with kidney transplant. At different times, each participant will take either probiotics or look-alike capsules with no probiotics. Researchers will compare the levels of immunosuppressant in the blood when participants take the probiotics with those when they take the capsules with no microbes.
Study participants will have to:
- Take oral capsules containing a probiotc mixture for one month and look-alike capsules with no probiotics for another month with a one-month interval between these two treatments;
- Go to the hospital every 30 days for three months for the collection of blood samples;
- Collect feces specimens for microbiome analysis every 30 days for three months and bring them to the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo first | Experimental | Other: Probiotic formulation, Other: PlaceboPatients first receive a placebo, followed by probiotics after a washout period |
| probiotic first | Experimental | Other: Probiotic formulation, Other: PlaceboPatients first receive probiotic, followed by placebo after a washout period |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- kidney transplant at least 12 months prior to enrollment
- No episodes of rejection in the 6 months prior to enrollment
- Immunosuppressive therapy with (in various combinations) corticosteroids, cyclosporine, tacrolimus, sirolimus, everolimus, or mycophenolic acid at stable doses that do not require further adjustments
Key exclusion criteria (11 listed)
- Acute transplant rejection
- Acute or chronic bacterial or fungal infections
- Gastrointestinal resections
- Intensive care unit admission
- Recent (within the last 6 months) major surgeries
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 |
|---|---|---|
| Probiotic formulationA multistrain probiotic mixture, formulated in capsules for oral administration, containing L. plantarum, L. rhamnosus, L. acidophilus, L. casei, S. thermophilus, B. lactis and an extract of the plant Boswellia serrata. Capsules also contain microcrystalline cellulose, soy lecithin and magnesium dioxide as excipients. | Other | Placebo first, probiotic first |
| PlaceboPlacebo capsules contain only the excipients found in the probiotic preparation (microcrystalline cellulose, soy lecithin and magnesium dioxide). They are indistinguishable from probiotic capsules. | Other | Placebo first, probiotic first |
Primary outcome
Changes in immunosuppressant drug blood levels
Time frame: Immunosuppressant blood levels will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Cyclosporin A, tacrolimus and sirolimus will be measured using CMIA (Chemiluminescent Microparticle Immunoassay); everolimus using QMS (Quantitative Microsphere System); mycophenolic acid using CEDIA (Cloned Enzyme Donor Immunoassay); and prednisolone using ELISA (Enzyme-Linked Immunosorbent Assay).
15 secondary outcomes
Changes in the blood levels of high-sensitivity C-reactive protein (hsCRP)
Time frame: High-sensitivity C-reactive protein (hsCRP) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Changes in the blood levels of interleukin-1β (IL-1β)
Time frame: Interleukin-1β (IL-1β) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Changes in the blood levels of interleukin-6 (IL-6)
Time frame: Interleukin-1β (IL-1β) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Changes in the blood levels of tumor necrosis factor-α (TNF-α)
Time frame: Tumor necrosis factor-α (TNF-α) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Changes in the blood urea nitrogen (BUN)
Time frame: BUN will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Changes in serum creatinine
Time frame: Serum creatinine will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Changes in Estimated Glomerular Filtration Rate (eGFR)
Time frame: eGFR will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Body weight
Time frame: Body weight will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period
Body Mass Index (BMI)
Time frame: Body Mass Index (BMI) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Waist circumference
Time frame: Waist circumference will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Total body water
Time frame: Total body water will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Extracellular water
Time frame: Extracellular water will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Fat Mass (FM)
Time frame: Fat Mass (FM) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Fat Free Mass (FFM)
Time frame: Fat Free Mass (FFM) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Phase Angle (PhA)
Time frame: Phase Angle (PhA) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 38571475Huang HW, Chen MJ. Exploring the Preventive and Therapeutic Mechanisms of Probiotics in Chronic Kidney Disease through the Gut-Kidney Axis. J Agric Food Chem. 2024 Apr 17;72(15):8347-8364. doi: 10.1021/acs.jafc.4c00263. Epub 2024 Apr 4.
- Background: PubMed 31165878Chung S, Barnes JL, Astroth KS. Gastrointestinal Microbiota in Patients with Chronic Kidney Disease: A Systematic Review. Adv Nutr. 2019 Sep 1;10(5):888-901. doi: 10.1093/advances/nmz028.
- Background: PubMed 39170931Chen Z, Chang X, Ye Q, Gao Y, Deng R. Kidney transplantation and gut microbiota. Clin Kidney J. 2024 Aug 14;17(8):sfae214. doi: 10.1093/ckj/sfae214. eCollection 2024 Aug.
- Background: PubMed 42074989Di Renzo T, Reale A, Nazzaro S, Iovanna D, Evangelista D, Gautam V, Guida B, Carrano R, Cataldi M. Impact of Probiotics, Prebiotics and Synbiotics Supplementation in Chronic Kidney Disease: A Comprehensive Review of Clinical Trials. Nutrients. 2026 Apr 8;18(8):1176. doi: 10.3390/nu18081176.
- Background: PubMed 37761003Manes A, Di Renzo T, Dodani L, Reale A, Gautiero C, Di Lauro M, Nasti G, Manco F, Muscariello E, Guida B, Tarantino G, Cataldi M. Pharmacomicrobiomics of Classical Immunosuppressant Drugs: A Systematic Review. Biomedicines. 2023 Sep 18;11(9):2562. doi: 10.3390/biomedicines11092562.
- Individual participant dataSharing planned: Undecided
Related trials for Kidney Transplantation
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
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
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.
Mauro Cataldi, MD, PhD principal investigator
Federico II University of Naples, ITALY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic formulation in people with Kidney Transplantation and Kidney Transplantation Recipients, run by Federico II University at 1 site in Italy.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 20 Oct 2026. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in immunosuppressant drug blood levels (time frame: Immunosuppressant blood levels will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.). 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 NCT07884084, which also lists 5 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 20 Oct 2026.