NCT02954198

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

Completed NA Results posted Last updated 24 December 2019

What this trial tests

NA trial testing Tacrolimus in Immunosuppression in 40 participants. Completed in 27 December 2018.

Timeline

1 December 2016

Primary endpoint
27 December 2018

27 December 2018

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 December 2016
Primary completion	27 December 2018
Estimated completion	27 December 2018
Sites	1 location across United States

Drugs / interventions tested

• Tacrolimus (TACROLIMUS) — full drug profile →
• Prednisone (prednisone) — full drug profile →
• Mycophenolate mofetil (MYCOPHENOLATE MOFETIL) — full drug profile →
• Everolimus (everolimus) — full drug profile →

Conditions studied

• Immunosuppression — all drugs for Immunosuppression →

Sponsor

Medical University of South Carolina

Who can join

18 and older, any sex, with Immunosuppression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Self-reported Medication Adherence From Baseline to 6 Months. Primary · 6 months post conversion

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.

Baseline

Group	Value	95% CI
Control: Envarsus + MMF	80
Intervention: Envarsus + Everoliumus	45

6 months post-conversion

Group	Value	95% CI
Control: Envarsus + MMF	59
Intervention: Envarsus + Everoliumus	47

Percent of Participants Experiencing Acute Allograft Rejection Secondary · Baseline to 6 months post conversion

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.

Group	Value	95% CI
Control: Envarsus + MMF	0
Intervention: Envarsus + Everoliumus	0

Subject Specific Change on Medication Side Effect Scale Secondary · Baseline to 6 months post conversion

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

Group	Value	95% CI
Control: Envarsus + MMF	71	± 67
Intervention: Envarsus + Everoliumus	37	± 38

6 month post-conversion

Group	Value	95% CI
Control: Envarsus + MMF	93	± 86
Intervention: Envarsus + Everoliumus	38	± 34

Percent of Participants Who Experienced Kidney Transplant Graft Loss Secondary · Baseline to 6 months post conversion

Measure and compare time-to-event analysis between the two arms graft loss (time to event analysis)

Group	Value	95% CI
Control: Envarsus + MMF	0
Intervention: Envarsus + Everoliumus	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months from Baseline to end of study.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control: Envarsus + MMF

Serious: 1/20 (5%)

Deaths: 0/20

Intervention: Envarsus + Everoliumus

Serious: 1/20 (5%)

Deaths: 0/20

Serious adverse events (2 terms)

Reaction	System	Control: Envarsus + MMF	Intervention: Envarsus + E…
JC virus induced Progressive Multifocal Leukoencephalopathy	Infections and infestations	—	—
Perinephric fluid collection	Renal and urinary disorders	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	Control: Envarsus + MMF	Intervention: Envarsus + E…
Cytomegalovirus infection	Infections and infestations	—	—
Interstitial Fibrosis and Tubular Atrophy	Renal and urinary disorders	—	—
Borderline kidney rejection	Renal and urinary disorders	—	—
BK infection	Infections and infestations	—	—
Lymphocele	Immune system disorders	—	—
Diabetic foot ulcer	Skin and subcutaneous tissue disorders	—	—
Neutropenia	Investigations	—	—
Graft dysfunction	Renal and urinary disorders	—	—
Cardiovascular Event	Cardiac disorders	—	—

Most-reported serious reactions: JC virus induced Progressive Multifocal Leukoencephalopathy, Perinephric fluid collection.

Data from ClinicalTrials.gov NCT02954198 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.