Study on the effect of switching to Envarsus in renal transplant patients with tacrolimus-associated tremor

Phase 1

Conditions: Tacrolimus-associated tremor
MedDRA version: 20.0Level: PTClassification code 10044565Term: TremorSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2017-000784-33-ES

Lead Sponsor: Fundació Clínic per a la Recerca Biomèdica

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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;