Extended Release Tacrolimus vs. Twice-Daily Tacrolimus

• Status: Active, not recruiting
• Trial end date: 2022-10-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lorenzo Gallon
• Treatments: Immunosuppressive Agents; Tacrolimus

Criteria

Inclusion Criteria:

1. 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.

6. Subject (recipient) is able to understand the consent form and give written informed consent

Exclusion Criteria:

1. Delayed graft function (please see above).

2. Known sensitivity or contraindication to alemtuzumab, Envarsus® XR, tacrolimus or MMF.

3. Use of the following induction medications: basiliximab and rituximab

4. Patient with significant or active infection.

5. Patients with a positive flow cytometric crossmatch using donor lymphocytes and recipient serum.

6. Patients with PRA > 40%

7. Patients with current or historic donor specific antibodies

8. Body Mass Index (BMI) of < 18 or > 35

9. Patients who are pregnant or nursing mothers.

10. Patients whose life expectancy is severely limited by diseases other than renal disease.

11. Ongoing active substance abuse, drug or alcohol.

12. Major ongoing psychiatric illness or recent history of noncompliance.

13. Significant cardiovascular disease (e.g.):

• Significant non-correctable coronary artery disease;

• Ejection fraction below 30%;

• History of recent myocardial infarction.

14. Malignancy within 3 years, excluding non-melanoma skin cancers.

15. Serologic evidence of infection with HIV or HBVs-Ag positive.

16. Patients with a screening/baseline total white blood cell count < 4,000/mm3; platelet count < 100,000/mm3; triglyceride > 400 mg/dl; total cholesterol > 300 mg/dl.

17. Investigational drug within 30 days prior to transplant surgery.

18. Anti-T cell therapy within 30 days prior to transplant surgery.

19. Diagnosis of atypical-Hemolytic Uremic Syndrome (aHUS).

20. Subjects transplanted with a Hepatitis C NAT-positive kidney.