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

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Roberto Gedaly
Study ID
NCT03321656
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • End Stage Renal Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tacrolimus — DRUG
    0.1-0.2 mg/kg/day orally divided into two doses every 12 hours orally
  • Envarsus XR — DRUG
    0.07-0.14 mg/kg/day every morning orally

Study Details

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.

Key Dates

Start date
Mar 28, 2019
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Tacrolimus
    0.1 - 0.2 mg/kg/day in 2 divided doses every 12 hours orally
  • Experimental: Envarsus XR
    0.07-0.14 mg/kg/day every morning orally

Primary Outcome Measure

1. Change in the percentage of donor specific antibodies [ Time Frame: Time of transplant and six months post-transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Deepa ValviLexingtonKentucky40536
Deepa Valvi, DrPH
[email protected]
8592579443
Roberto Gedaly, MD (PRINCIPAL_INVESTIGATOR)
TrisAnn Rendulic, PharmD (SUB_INVESTIGATOR)

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Deepa Valvi· Lexington, KY

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