Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant

NCT03386305 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 5024
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the medication adherence, clinical efficacy, and safety of EnvarsusXR in stable post liver transplant patient using a Phase III randomized controlled study. The primary outcome is change in medication adherence from baseline to the end of the study, assessed using a validated instrument (BAASIS- Basel Assessment of Adherence with Immunosuppressive medication Scales) and standard deviation of Tacrolimus levels.

Conditions

Post Liver Transplant

Outcome Measures

Primary Outcomes (1)

• Change in Medication Adherence

  Self reported using BAASIS instrument. BAASIS measures taking, skipping and dose reduction of drugs, with a recall period of 4 weeks. It consists of 4 questions with a 6 point response scale (ranging from never to every day). An additional overall adherence is ranked on a scale of 0 to 100 using a visual analog scale.

  From baseline to 6 months

Secondary Outcomes (1)

• Change in Quality of life

  From baseline to 6 months

Study Arms (2)

EnvarsusXR arm

EXPERIMENTAL

Patients are converted to once daily EnvarsusXR (study drug). The patients continue taking this medication for 9 months of the study. Initial dosage will be 0.8 times the total daily dose of tacro bid, due to higher bioavailability. All subsequent dose adjustments will be based on maintenance of target tacro trough levels within range of 5-12 ng/ml.

Drug: EnvarsusXR

Standard of care arm

ACTIVE COMPARATOR

Post Liver Transplant patients take Tacrolimus twice daily as a part of standard of care. Those participating in the study will continue to take tacrolimus twice daily, as apart of their regular care. As a part of the study, they will complete the medication adherence and quality of life instruments.

Drug: Tacrolimus

Interventions

EnvarsusXR DRUG

Patients randomized to study drug will be converted to EnvarsusXR once daily.

Also known as: Immunosuppression

EnvarsusXR arm

Tacrolimus DRUG

Patients continue to take Tacrolimus BID, as a part of routine care.

Also known as: Standard of Care

Standard of care arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are 1 year post liver transplant, but within 5 years of transplant
• Serum Creatinine\<= 2.5 mg/dl; AST,ALT, AP and GGT\<=2 times ULN
• Patient must be on a stable tacrolimus dose, with tacrolimus trough levels between 5-12 ng/ml for 4 or more weeks before enrolment

You may not qualify if:

• Cognitive impairment which precludes participation
• Projected survival, in the opinion of the provider, of less than three months
• Any other solid organ transplant (kidney or pancreas)
• Use of any drug which is known to interfere with tacrolimus metabolism

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead
• Veloxis Pharmaceuticals: collaborator

Study Sites (1)

Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Interventions

Immunosuppression Therapy; Tacrolimus; Standard of Care

Intervention Hierarchy (Ancestors)

Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Macrolides; Lactones; Organic Chemicals; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Manisha Verma, MBBS, MPH

  Einstein Healthcare Network

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Chair, Transplantation

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 29, 2017
• Study Start: December 13, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)