Pharmacokinetics, Effectiveness and Tolerability of Prolonged-release Tacrolimus After Paediatric Kidney Transplantation
NCT ID: NCT06057545
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
30 participants
INTERVENTIONAL
2023-04-25
2025-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The aim of this study is to assess pharmacokinetic profiles of Envarsus® as well as effectiveness and tolerability of this drug in children and adolescents ≥ 8 and ≤ 18 years of age.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dosing Strategies for de Novo Once-daily Extended Release Tacrolimus (LCPT) in Kidney Transplant Recipients
NCT03713645
PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus
NCT04496401
Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared With Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in de Novo Kidney Transplant Patients
NCT02432833
Efficacy of Envarsus XR and Digital Health Technology in Reducing Tacrolimus Fluctuation and Frequency of Dose Changes
NCT04711291
Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation
NCT03511560
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A - Envarsus followed by Prograf
4 weeks treatment sequence 1 (Envarsus) followed by 4 weeks treatment sequence 2 (Prograf)
Envarsus®
Treatment sequence: 4 weeks prolonged-release tacrolimus (Envarsus®) once daily
Prograf
Treatment sequence: 4 weeks intermediate-release tacrolimus (Prograf®) twice daily
Group B - Prograf followed by Envarsus
4 weeks treatment sequence 2 (Prograf) followed by 4 weeks treatment sequence 1 (Envarsus)
Envarsus®
Treatment sequence: 4 weeks prolonged-release tacrolimus (Envarsus®) once daily
Prograf
Treatment sequence: 4 weeks intermediate-release tacrolimus (Prograf®) twice daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Envarsus®
Treatment sequence: 4 weeks prolonged-release tacrolimus (Envarsus®) once daily
Prograf
Treatment sequence: 4 weeks intermediate-release tacrolimus (Prograf®) twice daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. aged ≥ 8 years but ≤ 18 years who are under tacrolimus (Prograf®) therapy and who are able to swallow tablets with a minimum dose of 0.75 mg / day Envarsus®
3. not less than 6 months after transplantation
4. stable kidney function (delta eGFR \< 10 ml/min/1.73 m2 (CKID formula) over the last 3 months)
5. women of childbearing potential and women without childbearing potential
6. patient/parents/legal guardian(s) must be capable of understanding purpose and risks of the study
7. signed informed consent obtained by patient and parents/legal guardians
Exclusion Criteria
2. pregnancy/breast feeding
3. instable kidney function
4. hypersensitivity to any of the components of the medications used
5. not eligible for any reason according to the investigator's valuation
6. known positive HIV-1 or HCV test
7. participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)
8 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Essen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lars Pape, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Essen, Pediatrics II
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Cologne, Pediatrics
Cologne, , Germany
University Hospital of Essen, Pediatrics II
Essen, , Germany
University Hospital of Hamburg-Eppendorf
Hamburg, , Germany
University Hospital of Heidelberg
Heidelberg, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Lutz Weber, Prof. Dr.
Role: primary
Lars Pape, Prof. Dr.
Role: primary
Jun Oh, Prof. Dr.
Role: primary
Burkhard Tönshoff, Prof. Dr.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Karaterzi S, Tonshoff B, Ahlenstiel-Grunow T, Baghai M, Beck B, Buscher A, Eifler L, Giese T, Lezius S, Muller C, Oh J, Zapf A, Weber LT, Pape L. A multi-center interventional study to assess pharmacokinetics, effectiveness, and tolerability of prolonged-release tacrolimus after pediatric kidney transplantation: study protocol for a prospective, open-label, randomized, two-phase, two-sequence, single dose, crossover, phase III b trial. Front Nephrol. 2024 Feb 20;4:1331510. doi: 10.3389/fneph.2024.1331510. eCollection 2024.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro-Tac
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.