Kidney Disease, ChronicPhase 4TRANSPGxNCT06701825
Effectiveness and Cost-effectiveness of a Pre-emptive Genotyping Strategy in Patients Receiving Tacrolimus
A Phase 4 study testing Tacrolimus in people with Kidney Disease, Chronic and Transplant Recipient (Kidney), run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
This is a phase IV multicentre adaptive single-blinded randomized clinical trial to evaluate if preemptively genotyping populations at pretransplant chronic kidney disease susceptible of receiving tacrolimus therapy is effective, cost-effective, and feasible within the Spanish National Health System when compared to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Disease, Chronic, Transplant Recipient (Kidney), Immunosuppression
- What is being tested?
- Tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jun 2025to 31 Dec 2026
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
- Subject or their legally authorized representative has voluntarily signed the informed consent document.
- Participant is on the waiting list for a kidney transplant.
- Subject is able and willing to take part and be followed-up for the majority of the study duration, and adhere to the procedures specified in this protocol.
- Subjects must be naïve to any genotyping test of the following genes: CYP3A5.
Who cannot join
- Known hypersensitivity/allergy reaction to tacrolimus or any of the excipients.
- History of renal, heart, and/or liver transplant.
- History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere in a relevant manner with the absorption, distribution, metabolism, or excretion of the study treatment, except for renal disease.
- Any condition or situation precluding or interfering the compliance with the protocol.
- Any condition at medical discretion for which renal transplantation and/or study treatment should not be received.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital La Paz
Madrid, Madrid, 28046
Arturo Gomez Lopez de las Huertas, MD
About this study
Official title: A Multicentre, Controlled, Randomised and Single-blind, Adaptive Phase IV Protocol to Evaluate Effectiveness and Cost-effectiveness of Pre-emptive Genotyping Strategy to Optimise Tacrolimus Dosage in a Pretransplant Chronic Kidney Disease Population Cohort
This is a phase IV multicentre adaptive single-blinded randomized clinical trial to evaluate if preemptively genotyping populations at pretransplant chronic kidney disease susceptible of receiving tacrolimus therapy is effective, cost-effective, and feasible within the Spanish National Health System when compared to the current standard of care. This trial is nested within the iPHARMGx master protocol.
Read the detailed description
This is a nation-wide, multicentre, randomised, controlled, and adaptive phase IV clinical trial that aims to assess the effectiveness and cost-effective of pre-emptive pharmacogenetic testing strategies, including those impacted by genetic variants associated with adverse drug reactions (ADRs) or limited efficacy. The clinical trials will evaluate the effective and cost-effective of pre-emptive genotyping by defining a drug-gene-endpoint triad. Study subjects will be pre-emptively genotyped and, if found to have an actionable gene variant, randomly allocated to either a test group where guideline-based treatment modifications will be initiated or a control group that will be managed according to healthcare provider standard of care (SoC). Subsequently, subjects will be prospectively followed at prespecified timepoints. Detailed information on drug-gene-endpoint triads, allocation schemes, and follow-up visits will be provided in each of the subprotocols. A Data Monitoring Committee (DMC), composed of physician experts, will be appointed for each nested trial to review the data on an ongoing basis, ensuring the safety of participants and scientific validity of the study.
- Being tested
- Tacrolimus
- Keywords
- Tacrolimus, Kidney transplant, Cost-effectiveness, Pharmacogenetic, Phase IV Clinical Trial
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Tacrolimus at the dosage reccomended by the "Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for CYP3A5 Genotype and Tacrolimus Dosing" based on the subjects pharmacogenetic phenotype.
TacrolimusDrug
Subject allocated to this arm will receive tacrolimus according to clinical practice and the drug's product labelling. These subject will not receive a personalised dose based on their pharmacogenetic phenotype.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Patients in this control group will receive treatment with any formulation of Tacrolimus authorized and commercialized in Spain. They will be administered tacrolimus according to clinical practice and the drug's product labeling. Receives: Drug: Tacrolimus |
| Dose adjusted by guidelines | Experimental | Participants in this experimental group will receive treatment with any formulation of Tacrolimus authorized and commercialized in Spain. They will be administered the specific dosage of tacrolimus recommended by the Clinical Pharmacogenetics Consortium's genotype guidelines, utilizing the patient's pharmacogenetic information and characteristics. Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tacrolimus concentrations levels
Number and percentage of patients achieving tacrolimus target plasma concentrations at visit 3. Tacrolimus concentrations levels at day 4 (+/-1d) will be the effectiveness surrogate outcome. It will be considered therapeutic range levels between 7-10 ng/ml.
Measured: 4 days
Secondary outcomes (6)
Incremental cost-effectiveness ratio (ICER)
Cost-effectiveness ratio that divides the differences in costs between both treatments by the difference in effectiveness between both treatments.
Measured: Though study completion, on average 18 months
Number and percentage of patients with transplant rejection.
Transplant rejection will be considered if there is histological confirmation and/or the patient initiates any type of therapy aimed at treating rejection (e.g. corticosteroids).
Measured: Though study completion, on average 18 months
Rate of AE associated to treatment.
All adverse events associated to tacrolimus will be recorded during the study
Measured: Though study completion, on average 18 months
Number and percentage of patients achieving tacrolimus target plasma concentrations at visit 4, 5 and 6.
Measured: Week 4, 15 and 26
Healthcare expenditure related to predefined events of interest
Any costs made as a result of an AE
Measured: Though study completion, on average 18 months
Incidence of discontinuation or treatment modification
Incidence of discontinuation or treatment modification due to lack of effective related to the drug of inclusion.
Measured: Though study completion, on average 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start2 Jun 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Disease, ChronicStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase IV, multicentre, controlled, randomized, parallel and single-blind adaptive clinical trial nested within the iPHARMGx master protocol study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701825
- Sponsor's protocol ID
- 2024-516596-32-00
- Other IDs
- 2024-516596-32-00
- Acronym
- TRANSPGx
- Status last verified
- Sep 2025
- First submitted
- 20 Nov 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A copy of the database of data collected during the clinical trial will be attached as an appendix to the publication resulting from this clinical trial.
Publications
Seco-Meseguer E, Stewart S, Diago-Sempere E, Jimenez C, Macias Carmona N, Fernandez Solis J, Vila Santandreu A, Valero San Cecilio R, Lopez Jimenez V, Carmona-Rodriguez M, Lopez-Fernandez LA, Imaz-Iglesia I, Garcia-Saiz MDM, Farre M, Rodriguez-Jimenez C, Sanabria-Cabrera J, Rosas-Alonso R, Garcia-Garcia I, Borobia AM; iPHARMGx study group. Multicentre, controlled, randomised and single-blind, adaptive phase IV protocol to evaluate effectiveness and cost-effectiveness of a pre-emptive genotyping strategy to optimise tacrolimus dosage in a pretransplant chronic kidney disease population cohort: iPHARMGx TRANSPGx nested clinical trial. BMJ Open. 2026 Aug 3;16(8):e109279. doi: 10.1136/bmjopen-2025-109279.
PubMed 42547238
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Controlled, Randomised and Single-blind, Adaptive Phase IV Protocol to Evaluate Effectiveness and Cost-effectiveness of Pre-emptive Genotyping Strategy to Optimise Tacrolimus Dosage in a Pretransplant Chronic Kidney Disease Population Cohort
- ClinicalTrials.gov ID
- NCT06701825
- Acronym / sponsor ID
- TRANSPGx / 2024-516596-32-00
- Keywords
- Tacrolimus, Kidney transplant, Cost-effectiveness, Pharmacogenetic, Phase IV Clinical Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Nov 2024 (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 phase IV multicentre adaptive single-blinded randomized clinical trial to evaluate if preemptively genotyping populations at pretransplant chronic kidney disease susceptible of receiving tacrolimus therapy is effective, cost-effective, and feasible within the Spanish National Health System when compared to the current standard of care. This trial is nested within the iPHARMGx master protocol.
Detailed description
This is a nation-wide, multicentre, randomised, controlled, and adaptive phase IV clinical trial that aims to assess the effectiveness and cost-effective of pre-emptive pharmacogenetic testing strategies, including those impacted by genetic variants associated with adverse drug reactions (ADRs) or limited efficacy. The clinical trials will evaluate the effective and cost-effective of pre-emptive genotyping by defining a drug-gene-endpoint triad. Study subjects will be pre-emptively genotyped and, if found to have an actionable gene variant, randomly allocated to either a test group where guideline-based treatment modifications will be initiated or a control group that will be managed according to healthcare provider standard of care (SoC). Subsequently, subjects will be prospectively followed at prespecified timepoints. Detailed information on drug-gene-endpoint triads, allocation schemes, and follow-up visits will be provided in each of the subprotocols. A Data Monitoring Committee (DMC), composed of physician experts, will be appointed for each nested trial to review the data on an ongoing basis, ensuring the safety of participants and scientific validity of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Phase IV, multicentre, controlled, randomized, parallel and single-blind adaptive clinical trial nested within the iPHARMGx master protocol study
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Drug: TacrolimusPatients in this control group will receive treatment with any formulation of Tacrolimus authorized and commercialized in Spain. They will be administered tacrolimus according to clinical practice and the drug's product labeling. |
| Dose adjusted by guidelines | Experimental | Drug: TacrolimusParticipants in this experimental group will receive treatment with any formulation of Tacrolimus authorized and commercialized in Spain. They will be administered the specific dosage of tacrolimus recommended by the Clinical Pharmacogenetics Consortium's genotype guidelines, utilizing the patient's pharmacogenetic information and characteristics. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
- Subject or their legally authorized representative has voluntarily signed the informed consent document.
- Participant is on the waiting list for a kidney transplant.
- Subject is able and willing to take part and be followed-up for the majority of the study duration, and adhere to the procedures specified in this protocol.
- Subjects must be naïve to any genotyping test of the following genes: CYP3A5.
Key exclusion criteria (5 listed)
- Known hypersensitivity/allergy reaction to tacrolimus or any of the excipients.
- History of renal, heart, and/or liver transplant.
- History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere in a relevant manner with the absorption, distribution, metabolism, or excretion of the study treatment, except for renal disease.
- Any condition or situation precluding or interfering the compliance with the protocol.
- Any condition at medical discretion for which renal transplantation and/or study treatment should not be received.
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 |
|---|---|---|
| TacrolimusTacrolimus at the dosage reccomended by the "Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for CYP3A5 Genotype and Tacrolimus Dosing" based on the subjects pharmacogenetic phenotype. | Drug | Standard of care |
| TacrolimusSubject allocated to this arm will receive tacrolimus according to clinical practice and the drug's product labelling. These subject will not receive a personalised dose based on their pharmacogenetic phenotype. | Drug | Dose adjusted by guidelines |
Primary outcome
Tacrolimus concentrations levels
Time frame: 4 days
Number and percentage of patients achieving tacrolimus target plasma concentrations at visit 3. Tacrolimus concentrations levels at day 4 (+/-1d) will be the effectiveness surrogate outcome. It will be considered therapeutic range levels between 7-10 ng/ml.
6 secondary outcomes
Incremental cost-effectiveness ratio (ICER)
Time frame: Though study completion, on average 18 months
Number and percentage of patients with transplant rejection.
Time frame: Though study completion, on average 18 months
Rate of AE associated to treatment.
Time frame: Though study completion, on average 18 months
Number and percentage of patients achieving tacrolimus target plasma concentrations at visit 4, 5 and 6.
Time frame: Week 4, 15 and 26
Healthcare expenditure related to predefined events of interest
Time frame: Though study completion, on average 18 months
Incidence of discontinuation or treatment modification
Time frame: Though study completion, on average 18 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 11 Sep 2025.
- Derived from this study: PubMed 42547238Seco-Meseguer E, Stewart S, Diago-Sempere E, Jimenez C, Macias Carmona N, Fernandez Solis J, Vila Santandreu A, Valero San Cecilio R, Lopez Jimenez V, Carmona-Rodriguez M, Lopez-Fernandez LA, Imaz-Iglesia I, Garcia-Saiz MDM, Farre M, Rodriguez-Jimenez C, Sanabria-Cabrera J, Rosas-Alonso R, Garcia-Garcia I, Borobia AM; iPHARMGx study group. Multicentre, controlled, randomised and single-blind, adaptive phase IV protocol to evaluate effectiveness and cost-effectiveness of a pre-emptive genotyping strategy to optimise tacrolimus dosage in a pretransplant chronic kidney disease population cohort: iPHARMGx TRANSPGx nested clinical trial. BMJ Open. 2026 Aug 3;16(8):e109279. doi: 10.1136/bmjopen-2025-109279.
- Individual participant dataSharing planned: Yes. A copy of the database of data collected during the clinical trial will be attached as an appendix to the publication resulting from this clinical trial.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus in people with Kidney Disease, Chronic and Transplant Recipient (Kidney), run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 5 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 11 Sep 2025. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Alberto M. Borobia, MD, PhD (+34 912071466, alberto.borobia@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tacrolimus concentrations levels (time frame: 4 days). 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 NCT06701825, which also lists 1 linked publication.
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 2025.