Kidney Transplant Failure and Rejection Clinical Trial
— AGEINGOfficial title:
AGe-adapted Benefits of Envarsus Versus Twice-daily Tacrolimus ImmunosuppressioN druGs After Kidney Transplantation (AGEING) - a Feasibility Study
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | October 2019 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - kidney alone transplant, age =60, known sensitivity to tacrolimus Exclusion Criteria: - contra-indication to transplantation, multi-organ transplant, aged <60 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital Birmingham NHS Foundation Trust |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment rates | 6-months | No | |
Secondary | Treatment failure (composite endpoint of mortality, graft survival, rejection, loss to follow up) | 6-months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04057742 -
AlloSure for the Monitoring of Antibody Mediated Processes After Kidney Transplantation
|
||
Recruiting |
NCT03465397 -
Individualization of the Immunological Risk Based on Selective Biomarkers in Living-donor Renal Recipients
|
Phase 4 | |
Completed |
NCT03437577 -
Comparison of the Cognitive and Motor Effects of Treatment Between an Immediate- and Extended-release Tacrolimus (Envarsus® XR) Based Immunosuppression Regimen in Kidney Transplant Recipients
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05282966 -
Assessment of QSant™ for Underlying Allograft Rejection
|
||
Recruiting |
NCT04388930 -
The Microbiota in Kidney Donation and Transplantation
|
||
Completed |
NCT03611621 -
A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation
|
||
Recruiting |
NCT05397821 -
Pediatric Kidney Transplantation, Ureteroneocystostomy Techniques
|
||
Completed |
NCT04019353 -
Cf-DNA Assay During Treatment of Acute Rejection
|
||
Recruiting |
NCT05806749 -
Immunological Tolerance in Patients With Mismatched Kidney Transplants
|
Phase 1 | |
Recruiting |
NCT04936282 -
Treatment of Early Borderline Lesions in Low Immunological Risk Kidney Transplant Patients (TRAINING)
|
Phase 4 | |
Enrolling by invitation |
NCT05285878 -
Fingolimod for the Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation
|
Phase 2 | |
Recruiting |
NCT04526431 -
Tacrolimus Pharmacokinetic Subpopulations
|
||
Active, not recruiting |
NCT03511560 -
Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation
|
Phase 4 | |
Recruiting |
NCT03438773 -
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
|
Phase 1 | |
Completed |
NCT05388955 -
Risk Assessment Tool for Graft Survival in Pediatric Kidney Transplantation
|
||
Completed |
NCT06394596 -
Predicting Prognostic Factors in Kidney Transplantation Using A Machine Learning
|
||
Completed |
NCT04413916 -
MiRNA in Kidney Transplantation: Association With Kidney Graft Function and Disease Process
|
||
Completed |
NCT03466775 -
Anti-Angiotensin II Type 1 Receptor Antibodies and Kidney Transplant Outcomes
|
N/A | |
Active, not recruiting |
NCT04733131 -
Long-term Outcomes After Conversion to Belatacept
|
||
Active, not recruiting |
NCT03380962 -
Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant
|
Phase 1/Phase 2 |