Once-daily Regimen With Envarsus® to Optimize Immunosuppression Management and Outcomes in Kidney Transplant Recipients

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Immunosuppression

Treatments: Drug: Prednisone; Drug: Everolimus; Drug: Mycophenolate mofetil; Drug: Tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT02954198

Pro00059602

Details and patient eligibility

About

With the availability of well-studied once-daily formulations of tacrolimus, the ability to achieve a true once-daily immunosuppressant regimen along with everolimus and steroids may finally be achievable and have the potential to optimize immunosuppression safety and efficacy in kidney transplantation.

Full description

A once-daily immunosuppressant regimen comprising of Envarsus-everolimus-prednisone will have 6-month treatment failure rates that are non-inferior to the twice-daily regimen of Envarsus-mycophenolate mofetil-prednisone and will have improved patient-reported adherence.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion criteria

2. Male or female adult (≥18 years old) with a history of solitary kidney transplant within 3 months (±2 months) of transplant with self-reported medication adherence issues, as indicated by a MMAS-8 of at least 1.

3. Patients must be capable of understanding the purposes and risks of the study and have the ability to give written informed consent and be willing to participate and comply with the study.

4. Women of childbearing potential must have a negative pregnancy test within the 48 hours prior to receiving study medication.

5. Women of childbearing potential and sexually active males must be willing to use contraception, as indicated in Section 6 of the protocol. Subjects who are not of reproductive potential (status post bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or vasectomy), not sexually active, whose current partner(s) is not of reproductive potential, or whose sexual activity is exclusively homosexual are eligible without requiring the use of contraception.

6. Exclusion criteria

7. Patients will be excluded if they are pregnant or nursing females or males with a pregnant female partner

8. Recipient of multiple organ transplant

9. Recipient of a non-renal organ

10. Proteinuria > 800 mg/24 hour

11. eGFR < 30 ml/min

12. WBC ≤ 2k/mm3

13. Plt ≤ 50k/mm3

14. Triglycerides > 500 mg/dL

15. HIV positive (HIV ab +)

16. Unable to tolerate oral medications

17. Use of another investigational product within thirty days prior to receiving study medication

18. Acute graft rejection within the past month (Banff 1A or higher) or received an ABO incompatible donor organ.

19. A condition or disorder that, in the opinion of the investigator, may adversely affect the outcome of the study or the safety of the subject

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Tacrolimus + MMF

Active Comparator group

Description:

Tacrolimus IR BID (5-12ng/mL) + mycophenolate mofetil 1g BID + prednisone x at least 3 months, then converted to Tacrolimus Daily (5 -12ng/mL) + mycophenolate mofetil 1g BID + prednisone x 6 months

Treatment:

Drug: Tacrolimus

Drug: Mycophenolate mofetil

Drug: Prednisone

Envarsus + Everolimus

Active Comparator group

Description:

Tacrolimus IR BID (5-12ng/mL) + mycophenolate mofetil 1g BID + prednisone x at least 3 months, then converted to Envarsus Daily (2-5ng/mL) + Everolimus Daily (3-8ng/mL) + prednisone x 6 months

Treatment:

Drug: Tacrolimus

Drug: Everolimus

Drug: Prednisone