Trasplante renal y inmunosupresión
Conditions
Interventions
Trade Name: Envarsus
Pharmaceutical Form: Tablet
INN or Proposed INN: TACROLIMUS
CAS Number: 104987-11-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: not less then
Concentration
Sponsors
Consorci Mar Parc de Salut
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with a stable kidney transplant after the first year of the transplant, with low immunological risk. 2. At least during the last 3 months before entering the trial, both the 8 patients treated with Advagraf® and the 8 patients treated with Envarsus® should not have presented relevant changes in the dose (consider relevant changes> 1 mg in dose) and blood levels should be between 4 and 10 ng / ml. 3. Patients treated with Myfortic® that have not presented relevant changes in the dose, during the last 3 months before entering the study. 4. Patients treated with a dose of Prednisone of 5 mg / day at least during the 3 months before entering the study. 5. Patients =18 years. 6. Caucasian patients. 7. BMI between 18.5-29.9 Kg / m2. 8. Patient who have given their written consent to participate in the trial. 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 6 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Drug interaction that may interfere with the bioavailability of tacrolimus (Annex 1). 2. Patients with a history of neoplasic gastrointestinal disease (gastrointestinal disease or gastrointestinal surgery) 3. Changes in intestinal transit (diarrhea or constipation), or any significant increase in bowel movements per day during the last week of inclusion in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable;Main Objective: To assess the influence of fasting or food intake on the bioavailability and pharmacokinetic characteristics of tacrolimus in the preparation Envarsus® compared to Advagraf® in stable patients with kidney transplantation.;Secondary Objective: To compare tolerability (when we refer to the amount and severity of adverse effects) between Envarsus® and Advagraf® | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Spain
Contacts
Public ContactHospital del Mar
Consorci Mar Parc de Salut
Outcome results
None listed