Pharmacokinetic Study of ENVARSUS in Adult De-novo Kidney Transplant Patients

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Open-label, multicentre, randomized clinical trial to compare the pharmacokinetics of ENVARSUS® tablets and ADVAGRAF® capsules administered once daily in adult de-novo kidney transplant patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• Recipients of a kidney transplant from a deceased donor or a living donor

Exclusion Criteria:

• Recipient of any transplanted organ other than a kidney;

• Recipients of a bone marrow or stem cell transplant;

• Recipients of a kidney from a cardiac death donor;

• Recipients of a kidney from an ABO incompatible donor;