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Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile

NCT03321656 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-03-24

No results posted yet for this study

Summary

This will be a single center, prospective, open-label, randomized, controlled trial comparing Envarsus XR® to twice-daily tacrolimus. The targeted population will be patients with end stage renal disease listed for primary solitary kidney transplant. Transplant Surgery is not part of the study.

Conditions

Interventions

DRUG

Tacrolimus

0.1-0.2 mg/kg/day orally divided into two doses every 12 hours orally

DRUG

Envarsus XR

0.07-0.14 mg/kg/day every morning orally

Sponsors & Collaborators

  • Veloxis Pharmaceuticals

    collaborator INDUSTRY

  • Roberto Gedaly

    lead OTHER

Principal Investigators

  • Roberto Gedaly, MD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-03-28
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03321656 on ClinicalTrials.gov