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

NCT ID: NCT02954198

Last Updated: 2019-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2018-12-27

Brief Summary

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.

Detailed 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.

Conditions

Immunosuppression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tacrolimus + MMF

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

Group Type: ACTIVE_COMPARATOR

Tacrolimus

Intervention Type: DRUG

goal trough level 5-12ng/mL

Prednisone

Intervention Type: DRUG

goal dose 5mg QD

Mycophenolate mofetil

Intervention Type: DRUG

goal dose 1g BID

Envarsus + Everolimus

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

Group Type: ACTIVE_COMPARATOR

Tacrolimus

Intervention Type: DRUG

goal trough level 5-12ng/mL

Prednisone

Intervention Type: DRUG

goal dose 5mg QD

Everolimus

Intervention Type: DRUG

goal trough level 3-8ng/mL

Interventions

Tacrolimus

goal trough level 5-12ng/mL

Intervention Type: DRUG

Prednisone

goal dose 5mg QD

Intervention Type: DRUG

Mycophenolate mofetil

goal dose 1g BID

Intervention Type: DRUG

Everolimus

goal trough level 3-8ng/mL

Intervention Type: DRUG

Other Intervention Names

Envarsus; Corticosteroids; Methylprednisolone

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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.

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

4. 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.

Exclusion Criteria

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

2. Recipient of multiple organ transplant

3. Recipient of a non-renal organ

4. Proteinuria > 800 mg/24 hour

5. eGFR < 30 ml/min

6. WBC ≤ 2k/mm3

7. Plt ≤ 50k/mm3

8. Triglycerides > 500 mg/dL

9. HIV positive (HIV ab +)

10. Unable to tolerate oral medications

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

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

13. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

References

Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.

Reference Type: DERIVED

PMID: 36094829 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00059602

Identifier Type: -

Identifier Source: org_study_id