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Envarsus® Once Daily With Everolimus in Elderly Kidney Transplant Recipients: Pharmacokinetic and Clinical Study

NCT02970630 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-03-01

No results posted yet for this study

Summary

Prospective, single-arm, open-label, multicentre study with the principal aim to estimate tacrolimus pharmacokinetic parameters in elderly de-novo kidney transplant recipients of ECD (Extended Criteria Donor) kidney grafts treated with Envarsus® prolonged release tablets in combination with everolimus tablets.

Conditions

  • Kidney Transplantation

Interventions

DRUG

Tacrolimus

once a day

DRUG

Everolimus

twice daily

Sponsors & Collaborators

  • Cromsource

    collaborator INDUSTRY

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Paolo Rigotti, MD · Az Osp Padova, Osp. Civile Padova

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-02-22
Completion
2018-02-22

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02970630 on ClinicalTrials.gov