AGe-adapted Benefits of Envarsus Versus Twice-daily Tacrolimus ImmunosuppressioN druGs After Kidney Transplantation

NCT03005236 | Unknown Phase 4 DMC

• 1 other identifier: AGEING
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The proportion of elderly patients with end-stage kidney disease undergoing renal replacement therapy (RRT) is steadily increasing. Although kidney transplantation remains the optimal RRT of choice, it is clear that older adults have a differential risk versus benefit profile after kidney transplantation compared to younger adults. No age-adapted immunosuppression for older adults has been shown to improve kidney allograft outcomes but recent sub-analyses of clinical trial data has hinted at improved outcomes for older kidney transplant patients receiving Envarsus versus standard twice-daily tacrolimus formulations. This feasibility study will investigate this effect to see whether a full scale randomised controlled trial is warranted and to provide information regarding study feasibility.

Conditions

Kidney Transplant Failure and Rejection

Keywords

Kidney transplant; Tacrolimus; Envarsus; Older adult; Elderly

Outcome Measures

Primary Outcomes (1)

• Recruitment rates

  6-months

Secondary Outcomes (1)

• Treatment failure (composite endpoint of mortality, graft survival, rejection, loss to follow up)

  6-months

Study Arms (2)

Envarsus

EXPERIMENTAL

Basiliximab induction with maintenance therapy of Envarsus, mycophenolate mofetil and corticosteroids. Envarsus constitutes the experimental component of immunosuppression in older kidney transplant recipients.

Drug: ENVARSUS

Standard twice daily tacrolimus

ACTIVE COMPARATOR

Basiliximab induction with maintenance therapy of standard tacrolimus, mycophenolate mofetil and corticosteroids. Standard tacrolimus constitutes the control component of immunosuppression in older kidney transplant recipients.

Drug: Standard twice daily tacrolimus

Interventions

ENVARSUS DRUG

Envarsus is a once-a-day oral formulation of tacrolimus.

Envarsus

Standard twice daily tacrolimus DRUG

Standard tacrolimus will include twice-daily formulations that are currently available.

Standard twice daily tacrolimus

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• kidney alone transplant, age ≥60, known sensitivity to tacrolimus

You may not qualify if:

• contra-indication to transplantation, multi-organ transplant, aged \<60

Sponsors & Collaborators

• University Hospital Birmingham NHS Foundation Trust: lead

MeSH Terms

Conditions

Rejection, Psychology

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Adnan Sharif, MD

  Consultant Nephrologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adnan Sharif, MD

CONTACT

0121 371 5861; adnan.sharif@uhb.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Nephrologist

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 29, 2016
• Study Start: April 1, 2017
• Primary Completion: April 1, 2019
• Study Completion: October 1, 2019
• Last Updated: December 29, 2016

Record last verified: 2016-12