Clinical trial • Phase IV • Nephrology
TACROLIMUS for Chronic kidney disease | Kidney transplant (pre-transplant)
Phase IV trial of TACROLIMUS for Chronic kidney disease | Kidney transplant (pre-transplant).
Overview
- Trial Therapeutic Area
- Nephrology
- Trial Disease
- Chronic kidney disease | Kidney transplant (pre-transplant)
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 05-11-2024
- First CTIS Authorization Date
- 17-01-2025
Trial design
Randomised, control arm: tacrolimus standard of care as determined by the healthcare provider. intervention arm: tacrolimus dose prescribed according to the most recent clinical pharmacogenetic guideline treatment/dosing recommendations for the participant's genetic profile., adaptive Phase IV trial across 6 sites in Spain.
- Randomised
- Yes
- Comparator
- Control arm: tacrolimus standard of care as determined by the healthcare provider. Intervention arm: tacrolimus dose prescribed according to the most recent clinical pharmacogenetic guideline treatment/dosing recommendations for the participant's genetic profile.
- Adaptive
- True, adaptive clinical trial design (described as adaptive in protocol; further details and rationale referenced in the iPHARMGx master protocol).
- Biomarker Stratified
- True, CYP3A5 genotype (genotype-guided dosing according to clinical pharmacogenetic guideline).
- Target Sample Size
- 114
Eligibility
Recruits 114 paediatric patients.
- Vulnerable Population
- Minors are included (there are specific consent documents for legal guardians and an assent form for mature minors). Written informed consent is required from participants prior to any study procedures; where applicable the legally authorised representative (tutor) may sign. Specific subject information and informed consent forms exist for adults, for tutors/legal guardians, and an assent form for mature minors.
Inclusion criteria
- {"criterion_text":"- Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.\n- Subject or their legally authorized representative has voluntarily signed the informed consent document.\n- Participant is on the waiting list for a kidney transplant.\n- 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.\n- Subjects must be naïve to any genotyping test of the following genes: CYP3A5."}
Exclusion criteria
- {"criterion_text":"- Known hypersensitivity/allergy reaction to tacrolimus or any of the excipients.\n- History of renal, heart, and/or liver transplant.\n- 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.\n- Any condition or situation precluding or interfering the compliance with the protocol.\n- Any condition at medical discretion for which renal transplantation and/or study treatment should not be received."}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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.","definition_or_measurement_approach":"Tacrolimus concentrations measured at day 4 (+/-1 day); therapeutic range defined as 7-10 ng/ml."}
Secondary endpoints
- {"endpoint_text":"- Ratio that divides the differences in costs between both treatments by the difference in effectiveness between both treatments.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Number and percentage of patients achieving tacrolimus target plasma concentrations.","definition_or_measurement_approach":""}
- {"endpoint_text":"- 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).","definition_or_measurement_approach":"Transplant rejection defined by histological confirmation and/or initiation of therapy aimed at treating rejection (for example corticosteroids)."}
- {"endpoint_text":"- Rate of adverse events associated to treatment.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Healthcare expenditure related to predefined events of interest: Any costs made as a result of an adverse event.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence of discontinuation or treatment modification due to lack of effective related to the drug of inclusion.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Identification of new actionable genes/relevant polymorphisms within the predefined population subsets.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Novel prognostic and predictive genetic biomarkers of tacrolimus safety and effectiveness will be assessed trough techniques only available at Nation Centre of Oncological Investigations (CNIO) and genome-wide association studies when applicable.","definition_or_measurement_approach":"Assessment using techniques available at CNIO and genome-wide association studies when applicable."}
Recruitment
- Planned Sample Size
- 114
- Recruitment Window Months
- 24
- Consent Approach
- Written informed consent is required prior to any study procedures. The subject or their legally authorised representative must voluntarily sign the informed consent document. Specific subject information and consent documents are provided for adults, for tutors/legal guardians (consent by tutor), and an assent form exists for mature minors. The protocol states participants must be willing and able to provide written informed consent and/or have consent provided by a legally authorised representative where applicable.
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 114
Spain
- Earliest CTIS Part Ii Submission Date
- 18-12-2024
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 492
- Number Of Sites
- 6
- Number Of Participants
- 114
Sites
- Site Name
- Hospital Universitario De Canarias
- Department Name
- Nephrology
- Contact Person Name
- Juan Fernandez Solis
- Contact Person Email
- juanfdezsolis@outlook.com
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Nephrology
- Contact Person Name
- Nicolás Macías Carmona
- Contact Person Email
- nicolas.macias@salud.madrid.org
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Nephrology
- Contact Person Name
- Verónica López Jiménez
- Contact Person Email
- veronicaa.lopez.sspa@juntadeandalucia.es
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Nephrology
- Contact Person Name
- María Molina Gómez
- Contact Person Email
- mmolinago.germanstrias@gencat.cat
- Site Name
- Hospital Universitario La Paz
- Department Name
- Nephrology
- Contact Person Name
- Carlos Jiménez
- Contact Person Email
- cjmartin@salud.madrid.org
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Nephrology
- Contact Person Name
- Rosalía Valero San Cecilio
- Contact Person Email
- rosalia.valero@scsalud.es
Sponsor
Primary sponsor
- Full Name
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
- Organisation Type
- Patient organisation/association
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Tacrolimus STADA 0,5 mg cápsulas duras EFG
- Active Substance
- TACROLIMUS
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised/marketed
- Investigational Product Name
- Advagraf 0.5 mg prolonged-release hard capsules
- Active Substance
- TACROLIMUS
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised/marketed
- Investigational Product Name
- Conferoport 0,5 mg cápsulas duras de liberación prolongada EFG
- Active Substance
- TACROLIMUS
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised/marketed
- Investigational Product Name
- Adoport 0,5 mg cápsulas duras EFG
- Active Substance
- TACROLIMUS
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised/marketed
- Investigational Product Name
- Prograf 0,5 mg Cápsulas duras
- Active Substance
- TACROLIMUS
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised/marketed
- Investigational Product Name
- Modigraf 0.2 mg oral granules, suspension
- Active Substance
- TACROLIMUS
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised/marketed
- Investigational Product Name
- Envarsus 0.75 mg prolonged-release tablets
- Active Substance
- TACROLIMUS
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised/marketed
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