Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients.

• Status: Not yet recruiting
• Trial end date: 2020-05-03
• Target enrollment: 100
• Participant gender: All

Summary

Study to compare pharmacokinetics of tacrolimus prolonged-release (PR) capsules and Advagraf® PR capsules in stable kidney transplant patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sandoz
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• Male or female patients aged ≥18 years;

• Patients with a Body Mass Index (BMI) included in the interval [18.5-33.0] kg/m²;

• Patients who received a primary kidney transplant at least 12 months prior to study entry

Exclusion Criteria:

• Evidence or suspicion of ongoing or persistent, acute or chronic rejection;

• Requirement for dialysis within the six months prior to study entry;

• Glomerular filtration rate (GFR) <30 mL/min

• Pregnant or breastfeeding women, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test;

• Intolerance to tacrolimus, excipients (including lactose, fructose or galactose), or similar products;