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

NCT02954198 | Completed Results DMC

• 1 other identifier: Pro00059602
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunosuppression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percent of Participants Experiencing Acute Allograft Rejection

  Baseline to 6 months post conversion

Other Outcomes (2)

• Subject Specific Change on Medication Side Effect Scale

  Baseline to 6 months post conversion

• Percent of Participants Who Experienced Kidney Transplant Graft Loss

  Baseline to 6 months post conversion

Study Arms (2)

Tacrolimus + MMF

ACTIVE COMPARATOR

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

Drug: Tacrolimus; Drug: Prednisone; Drug: Mycophenolate mofetil

Envarsus + Everolimus

ACTIVE COMPARATOR

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

Drug: Tacrolimus; Drug: Prednisone; Drug: Everolimus

Interventions

Tacrolimus DRUG

goal trough level 5-12ng/mL

Also known as: Envarsus

Envarsus + Everolimus; Tacrolimus + MMF

Prednisone DRUG

goal dose 5mg QD

Also known as: Corticosteroids, Methylprednisolone

Envarsus + Everolimus; Tacrolimus + MMF

Mycophenolate mofetil DRUG

goal dose 1g BID

Tacrolimus + MMF

Everolimus DRUG

goal trough level 3-8ng/mL

Envarsus + Everolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients will be excluded if they are pregnant or nursing females or males with a pregnant female partner
• Recipient of multiple organ transplant
• Recipient of a non-renal organ
• Proteinuria \> 800 mg/24 hour
• eGFR \< 30 ml/min
• WBC ≤ 2k/mm3
• Plt ≤ 50k/mm3
• Triglycerides \> 500 mg/dL
• HIV positive (HIV ab +)
• Unable to tolerate oral medications
• Use of another investigational product within thirty days prior to receiving study medication
• Acute graft rejection within the past month (Banff 1A or higher) or received an ABO incompatible donor organ.
• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• 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.

  PMID: 36094829 DERIVED

MeSH Terms

Interventions

Tacrolimus; Prednisone; Adrenal Cortex Hormones; Methylprednisolone; Mycophenolic Acid; Everolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Prednisolone; Pregnadienetriols; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Sirolimus

Results Point of Contact

• Title: Dr. David Taber
• Organization: Medical University of South Carolina

taberd@musc.edu

843-792-4003

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: November 3, 2016
• Study Start: December 1, 2016
• Primary Completion: December 27, 2018
• Study Completion: December 27, 2018
• Last Updated: December 24, 2019
• Results First Posted: December 24, 2019

Record last verified: 2019-12

Locations

US (1)