PHASE IV, OPEN, UNICENTRIC AND PILOT CLINICAL TRIAL TO EVALUATE THE INFLUENCE ON THE BIODISPONIBILITY AND PHARMACOKINETIC CHARACTERISTICS OF ENVARSUS® COMPARED WITH ADVAGRAF® OF FAST OR INGESTIONIN STABLE PATIENTS WITH RENAL TRANSPLANTATIO

Phase 1

• Conditions: Trasplante renal y inmunosupresión; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2017-004450-41-ES
• Lead Sponsor: Consorci Mar Parc de Salut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-30
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 16

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified