Prospective Pilot Feasibility Study Comparing Envarsus Once-a-day to Tacrolimus Twice-a-day Immunosuppressive Regimen on Drug Bioavailability in Hispanic First Time Kidney Transplant Recipients

NCT03438773 | Unknown Phase 1 FDA Drug

• 2 other identifiers: VLX001-17v01 01-Sep-2017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This investigator-initiated post-marketing study will evaluate the role of Hispanic ethnicity on drug dosing of Envarsus in first-time stable renal transplant recipients. Tacrolimus trough drug levels will be studied as a primary endpoint at 24 hours after drug dosing and at steady state (e.g., trough level at 3 months post conversion) and secondary compliance assessments will be done by pill counts at clinic visits. Secondary outcomes will be the safety of once a day dosing as well as assessment of graft rejection and graft failure. In addition, concentration/dose ratios will be analyzed. The results of this study will provide important information about dosing of once a day tacrolimus (Envarsus) in Hispanic kidney transplant patients, which represents the largest growing group of patients with End-Stage Renal Disease

Conditions

Kidney Transplant; Complications; Kidney Transplant Failure and Rejection

Keywords

Hispanic; First time kidney recipients

Outcome Measures

Primary Outcomes (1)

• Tacrolimus drug levels

  Tacrolimus trough drug levels will be studied as a primary endpoint at 24 hours after drug dosing and at steady state through local lab HPLC MS/MS assays.

  2 years

Study Arms (2)

Envarsus

OTHER

Study group - Envarsus once daily in addition to standard of care.

Drug: Envarsus

Tacrolimus

OTHER

Control group - Tacrolimus twice daily in addition to standard of care.

Drug: Tacrolimus

Interventions

Envarsus DRUG

Patients randomized into the Envarsus group will be prescribed Envarsus, mycophenolate and prednisone once daily.

Envarsus

Tacrolimus DRUG

Patients randomized to the Tacrolimus group will be prescribed Tacrolimus twice-daily with standard of care immunosuppression, anti-proliferative and prednisone once-daily.

Tacrolimus

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 18 years of age or older.
• The subject is a first time stable renal transplant patients, who have received their transplant at least 3 months before study entry.
• The subject is willing to commit to the study design.
• The subject is considered to have stable allograft function defined as no documented rejection episodes within one month of screening.
• The subject is not currently receiving treatment with other experimental therapies directed at their transplant.

You may not qualify if:

• The subject has undergone a prior organ or bone marrow transplant.
• The subject has taken any interacting/contraindicated drug determined by the Investigator within 30 days of administration of the protocol.
• Any study drug allergies and if there are high serum donor specific antibody levels (DSA) or a high panel reactive antibody level (PRA).
• Documented treatment of rejection within 30 days of onset of the screening visit.

Sponsors & Collaborators

• California Institute of Renal Research: lead
• Balboa Institute of Transplantation: collaborator
• University of California, San Diego: collaborator

Study Sites (1)

California Institute of Renal Research

San Diego, California, 92123, United States

RECRUITING

MeSH Terms

Conditions

Rejection, Psychology

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Arman Faravardeh, MD

  California Institute of Renal Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael C Gastauer

CONTACT

858-810-8155; mgastauer@balboaunited.org

Eva Gripp, LVN

CONTACT

858-637-4600; EGripp@balboaunited.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients randomized into the study group will be prescribed Envarsus, mycophenolate and prednisone as a regimen vs. standard therapy with twice a day tacrolimus, mycophenolate and prednisone. Patients randomized to the control group will be prescribed standard immunosuppression with tacrolimus twice a day, anti-proliferative twice a day, and prednisone once a day at doses that are standard at our institution.

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: February 20, 2018
• Study Start: July 11, 2018
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

US (1)