Tacrolimus-associated tremor MedDRA version: 20.0 Level: PT Classification code 10044565 Term: Tremor System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Envarsus prolonged-release tablets
Product Name: tacrolimus
Product Code: EU/1/14/935/004
Pharmaceutical Form: Tablet
Sponsors
Fundació Clínic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult kidney allograft recipients from a deceased or living donor (= 18 years old) who underwent transplantation between 12 and 18 months before inclusion in the study; - Patients receiving a stable un-interrupted oral dose of Advagraf® and achieving stable tacrolimus (TAC) trough concentrations between 5-10 ng/mL, since the last visit (steady state conditions); - Patients without signs of rejection in the per protocol biopsy performed at month 12 after transplantation; - Patients experiencing clinically significant tremor measured by DyCare wireless sensor (a wearable tool to evaluate movement disorders). - Patients that have signed the informed consent form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Patients receptors of simultaneous liver-kindey, heart-kidney or reno-pancreatic transplant; - Diagnosis of Parkinson's disease, or other neurological syndromes characterized by the occurrence of tremor; - Patients who participated in a clinical trial in the last 30 days; - Patient unable to swallow study medication; - Current abuse of drugs or alcohol; - Patient or donor with current diagnosis or history of malignancy (except basal-cell carcinoma or treated squamous cell carcinoma of the skin); - Known hypersensitivity to tacrolimus; - Pregnant or lactating women and all women physiologically capable of becoming pregnant UNLESS willing to use a highly efficacious method of contraception throughout the duration of the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the impact of conversion from prolonged-release tacrolimus Advagraf to Envarsus on the presence and severity of tremor;Secondary Objective: 1. Assessment of changes in pharmacodynamic and immunologic biomarkers related to neurotoxicity. 2. Study of the modification of the genetic profile induced by the conversion in peripheral blood samples. 3. Assess the impact of the switch from Advagraf to Envarsus on the quality of life of patients. 4. Evaluate dose adjustments in the conversion process. 5. Assess graft and patient survival after switching. 6. Evaluate renal function parameters and incidence of common ADRs related to immunosuppressant therapies.;Primary end point(s): Tremor assessment (RMS) using DyCare wireless gyroscope and accelerometer sensor before tacrolimus dosing (T0) and after two, four and six hours (T+2, +4, +6) , at Pre-conversion and same timing after 5 days, 1, 2 and 3 months of conversion.;Timepoint(s) of evaluation of this end point: 5, 30, 60 and 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change of blood and urine biomarkers related with neurotoxicity (before conversion, 30 days and 3 months after conversion): • Plasma: miRNA analysis (miR-210) • Urine samples: CXCL10 • Cytokine analysis: IL-12, IL-10 • Residual NFAT gene expression of IL-2, IFN-gamma - Modification of the genetic profile induced by conversion in peripheral blood samples: - Changes in the quality of life of the patients (quality of life in essential tremor questionnaire, QUEST) 3 months after the switch comparing to baseline score (pre-switch). - Treatment failures (death, graft failure, local BPAR (biopsy- proven acute rejection) or lost to follow-up).;Timepoint(s) of evaluation of this end point: 5, 30, 60 and 90 days | — |
Countries
Spain
Contacts
Public ContactApplicant
Fundació Clínic per a la Recerca Biomèdica
Outcome results
None listed