Clinical trial NCT02954198: Once-daily Regimen With Envarsus® to Optimize Immunosuppression Management and Outcomes in Kidney Transplant Recipients
Official title: Once-daily Regimen With Envarsus® to Optimize Immunosuppression Management and Outcomes in Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunosuppression
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2016-11-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 1. 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.

2. 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

Primary outcomes:
measure: Self-reported Medication Adherence From Baseline to 6 Months.
timeFrame: 6 months post conversion
Secondary outcomes:
measure: Percent of Participants Experiencing Acute Allograft Rejection
timeFrame: Baseline to 6 months post conversion
Other outcomes:
measure: Subject Specific Change on Medication Side Effect Scale
timeFrame: Baseline to 6 months post conversion
measure: Percent of Participants Who Experienced Kidney Transplant Graft Loss
timeFrame: Baseline to 6 months post conversion
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
citation: 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.