Phase 3 N=29 Randomized Treatment

Extended Release Tacrolimus vs. Twice-Daily Tacrolimus

End Stage Renal Disease · Rejection of Renal Transplant

Bottom Line

View on ClinicalTrials.gov: NCT03289650 ↗

Enrolled (actual)

Serious AEs

3.5%

Results posted

Apr 2023

Primary outcome: Primary: Change in Kidney Transplant Function From 2 Weeks Post Transplant Through 12 Months Post Transplant — 2.03; -2.19 mL/min/1.73m^2

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Tacrolimus (Drug); Tacrolimus Extended Release Oral Tablet [Envarsus] (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Lorenzo Gallon
Primary completion: Feb 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Kidney Transplant Function From 2 Weeks Post Transplant Through 12 Months Post Transplant	2.03; -2.19	—
SECONDARY Change in Subpopulations of T Cells From 2 Weeks Post Transplant Through 12 Months Post Transplant	—	—
SECONDARY Number of Participants With Acute Rejection at 3 Months and 12 Months Post-Transplant	0; 1; 0; 2	—
SECONDARY Number of Participants With Graft Loss at 3 Months and 12 Months Post-Transplant	0; 0; 0; 0	—
SECONDARY Number of Subjects Deceased at at 3 Months and 12 Months Post-Transplant	0; 0; 0; 0	—
SECONDARY Number of Participants With Change in Allograft Immunohistopathology Profile	2; 2; 2; 2; 0; 1	—

Summary

The overall aim of the study is to prospectively investigate the impact of two maintenance calcineurin inhibitor immunosuppressive regimens: once-daily extended release tacrolimus and twice-daily tacrolimus on subpopulations of T and B cells and alloreactive T cells as well as on renal allograft function.

Eligibility Criteria

Inclusion Criteria

Patients who are males or females aged 18-65 years. 2. Use of the following induction medications: basiliximab and rituximab. 2. Donors aged 18-65 years. 3. No prior organ transplant 4. Patients who are single-organ recipients (kidney only). 5. Women who are of childbearing potential must have a negative serum pregnancy test before transplantation and agree to use a medically acceptable method of contraception throughout the treatment period.
Subject (recipient) is able to understand the consent form and give written informed consent

Exclusion Criteria

Delayed graft function (please see above).
Known sensitivity or contraindication to alemtuzumab, Envarsus® XR, tacrolimus or MMF.
Use of the following induction medications: basiliximab and rituximab
Patient with significant or active infection.
Patients with a positive flow cytometric crossmatch using donor lymphocytes and recipient serum.
Patients with PRA > 40%
Patients with current or historic donor specific antibodies
Body Mass Index (BMI) of 35
Patients who are pregnant or nursing mothers.
Patients whose life expectancy is severely limited by diseases other than renal disease.
Ongoing active substance abuse, drug or alcohol.
Major ongoing psychiatric illness or recent history of noncompliance.
Significant cardiovascular disease (e.g.):
Significant non-correctable coronary artery disease;
Ejection fraction below 30%;
History of recent myocardial infarction.
Malignancy within 3 years, excluding non-melanoma skin cancers.
Serologic evidence of infection with HIV or HBVs-Ag positive.
Patients with a screening/baseline total white blood cell count 400 mg/dl; total cholesterol > 300 mg/dl.
Investigational drug within 30 days prior to transplant surgery.
Anti-T cell therapy within 30 days prior to transplant surgery.
Diagnosis of atypical-Hemolytic Uremic Syndrome (aHUS).
Subjects transplanted with a Hepatitis C NAT-positive kidney.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03289650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.