Pharmacokinetic Study of ENVARSUS in Adult De-novo Kidney Transplant Patients
NCT02500212 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2020-07-31
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.
Conditions
- Organ or Tissue Transplant; Complications
Interventions
- DRUG
-
ENVARSUS®
- DRUG
-
ADVAGRAF®
Sponsors & Collaborators
-
Chiesi Farmaceutici S.p.A.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-07-31
- Primary Completion
- 2016-06-30
- Completion
- 2016-06-30
Countries
- France
Study Locations
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