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Budesonide for Immunosuppression After Liver Transplantation to Reduce Side Effects

NCT03315052 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-09-23

No results posted yet for this study

Summary

Our hypothesis is that budesonide will provide effective hepatic ISP that will replace prednisone and allow lower systemic drug levels of FK, thus reducing the steroid- and calcineurin-associated complications often observed in the OLT population. This study is intended to investigate the therapeutic potential of this ISP combination.

Conditions

  • Acute Cellular Graft Rejection
  • Liver Transplant Rejection

Interventions

DRUG

Budesonide

Oral steroid with high first-pass metabolism in liver

DRUG

Tacrolimus（FK506）

Calcineurin immunosuppressant

DRUG

Mycophenolate Mofetil

Immunosupressant

DRUG

Prednisone

Immunosuppresant

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2021-01-31
Completion
2022-01-31
FDA Drug
Yes

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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 NCT03315052 on ClinicalTrials.gov