Immunosuppression in Renal transplant
Conditions
Interventions
Trade Name: Envarsus
Product Name: Envarsus
Pharmaceutical Form: Tablet
INN or Proposed INN: tacrolimus monohydrate
CAS Number: 109581-93-3
Trade Name: Adoport
Product Name: Adoport
Pharmaceutical Fo
Sponsors
University Hospitals Birmingham NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Recipient of kidney transplant • Age 60 and over Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: •Contra-indication to transplantation •Known allergy to tacrolimus •Multi-organ transplant •Age under 60 •Inability to provide valid informed consent •Deemed not appropriate for inclusion by physician in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to explore the use of Envarsus®, which is a once daily tacrolimus formulation, among older kidney transplant recipients compared to twice-daily tacrolimus. The trial will compare both treatment regimens among older kidney transplant candidates (aged 60 and over) being admitted for either living or deceased-donor kidney transplantation. It is designed as a feasibility study to explore the utility of planning a larger, multi-centre study with clinical meaningful endpoints.;Secondary Objective: The secondary research objectives for this project are to collect outcomes of: 1) post transplant rates of death, graft loss, rejection, graft function 2) cardio-metabolic complications such as incidence of post transplant diabetes, high cholesterol, hypertension and weight gain 3) side effects compared to twice-daily tacrolimus 4) patient-reported outcomes and quality of life 5) pharmacokinetic profiles ;Primary end point(s): The aim of this study is to explore the use of Envarsus® among older kidney transplant recipients compared to twice-daily tacrolimus. The trial will compare two treatment regimens among older kidney transplant candidates (aged 60 and over) being admitted for either living or deceased-donor kidney transplantation: Primary Outcome 1. Feasibility of study recruitment, assessment and willingness to complete 2. Model effect sizes and power for candidate randomised controlled trial primary outcomes, both in isolation and when combined as a composite outcome, to inform design of the follow-on randomised controlled trial. ;Timepoint(s) of evaluation of this end point: 6-months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Death, graft failure, acute rejection, graft function, drug-dose studies, cardio-metabolic parameters (incidence of post-transplant diabetes, cholesterol, BP, weight, cardiovascular events etc), proteinuria, donor-specific antibody, patient-reported outcomes measures (quality of life etc.), treatment failure (any of the following: death, transplant failure, biopsy-proven acute rejection or loss to follow-up), genotyping (SNP genotyping for pharmacogenomics);Timepoint(s) of evaluation of this end point: 6-months to 5-years | — |
Countries
United Kingdom
Contacts
Public ContactChirs Counsell
University Hospitals Birmingham
Outcome results
None listed