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Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR

NCT04773392 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-11-10

No results posted yet for this study

Summary

The purpose of this study is to determine if the combination of once-daily tacrolimus extended-release (EnvarsusXR) and Azathioprine is non inferior with respect to the composite outcome of acute rejection, graft and patient survival as compared to a combination of twice-daily immediate release tacrolimus and mycophenolate mofetil/mycophenolic acid.

Conditions

  • Kidney Transplantation
  • Kidney Transplant Rejection

Interventions

DRUG

Twice-daily Tacrolimus

Within 48 hours of transplantation, immediate release tacrolimus (IRT) (0.1 mg/kg /day) will be administered twice a day.

DRUG

Once-daily envarsus XR

Within 48 hours of transplantation, Envarsus XR (0.13mg/kg/day) will be administered once a day.

DRUG

Induction Immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG)

Induction immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG) per protocol. The dose of Basiliximab will be a standard of two 20 mg doses and total rATG will not exceed 6 mg/kg.

DRUG

Methylprednisolone, prednisone

Methylprednisolone intraoperatively (500mg) and immediately post transplantation (200mg on post operative day (POD) #1, 150mg on POD#2, 100mg on POD#3) then oral prednisone (50mg on POD #4, 20mg on POD #5). Oral prednisone will be tapered down to a minimal dose of 5mg within 6 weeks post transplantation.

DRUG

Mycophenolate mofetil (MMF) or Mycophenolic acid (MPA)

Mycophenolate mofetil (MMF) (up to 1000mg) or Mycophenolic acid (MPA) (up to 720mg) will be administered twice a day.

DRUG

Azathioprine

Azathioprine (1-3 mg/kg) will be administered once a day.

Sponsors & Collaborators

  • Veloxis Pharmaceuticals

    collaborator INDUSTRY

  • University of Southern California

    lead OTHER

Principal Investigators

  • Santhi Voora, MD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-23
Primary Completion
2024-02-23
Completion
2024-02-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04773392 on ClinicalTrials.gov