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

Immunosuppression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02954198
• Other study ID #: Pro00059602
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: December 27, 2018

Study information

• Verified date: December 2019
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 27, 2018
• Est. primary completion date: December 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immunosuppression

Intervention

Drug:
• Tacrolimus
goal trough level 5-12ng/mL
• Prednisone
goal dose 5mg QD
• Mycophenolate mofetil
goal dose 1g BID
• Everolimus
goal trough level 3-8ng/mL

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subject Specific Change on Medication Side Effect Scale	Examine subject specific change on a validated Medication Side Effect Scale at the time of the conversion versus six months post-conversion, compared between the two arms. Side effect burden scale is from 0 to 180. A lower score is less side effect burden, a higher score is more side effect burden.	Baseline to 6 months post conversion
Other	Percent of Participants Who Experienced Kidney Transplant Graft Loss	Measure and compare time-to-event analysis between the two arms graft loss (time to event analysis)	Baseline to 6 months post conversion
Primary	Self-reported Medication Adherence From Baseline to 6 Months.	Percent of subjects reporting high medication adherence at baseline compared to 6 months post-conversion, using the Morisky Medication Adherence scale (MMAS). The MMAS rates medication adherence on a scale of 0 to 8. 0 is high adherence, 1-2 is medium adherence, and greater than or equal to 3 is low adherence.	6 months post conversion
Secondary	Percent of Participants Experiencing Acute Allograft Rejection	Estimate the composite of treatment failure rate, defined as acute allograft rejection with a Banff grade 1A or higher, graft loss, or death at six months post-conversion, in patients converted to a once-daily immunosuppressant regimen of Envarsus®, everolimus, and prednisone versus patients converted to a twice-daily regimen of Envarsus®, MMF, and prednisone.	Baseline to 6 months post conversion