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Veloxis de Novo Kidney Transplant ECSWD

NCT03828682 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-05-13

No results posted yet for this study

Summary

This study is designed to evaluate the safety and efficacy of LCPT in combination with rATG, mycophenolate and early corticosteroid withdrawal (CSWD) in de novo kidney transplant recipients.

Conditions

  • Kidney Transplantation
  • Immunosuppression

Interventions

DRUG

Tacrolimus Extended Release Oral Tablet [Envarsus]

Tacrolimus Extended Release Oral Tablet \[Envarsus\]

DRUG

Mycophenolate Mofetil

Mycophenolate mofetil capsules or tablets

DRUG

Mycophenolic Acid Oral Product

mycophenolic acid tablets

DRUG

Tacrolimus

Twice daily tacrolimus

DRUG

Methylprednisolone

Methylprednisolone taper

DRUG

Prednisone

Prednisone taper

DRUG

Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin]

Rabbit Anti-Human T-Lymphocyte Globulin

Sponsors & Collaborators

  • Veloxis Pharmaceuticals

    collaborator INDUSTRY

  • Simon Tremblay, PharmD, PhD

    lead OTHER

Principal Investigators

  • Simon Tremblay, PharmD, PhD · University of Cincinnati

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-21
Primary Completion
2021-07-31
Completion
2022-06-30
FDA Drug
Yes

Countries

  • United States

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 NCT03828682 on ClinicalTrials.gov