Actively Recruiting
Study to Compare the Outcome of Receiving Continued Immunosuppression Versus Stopping Immunosuppression at 6 Months to Safely Prevent Human Leukocyte Antigen (HLA) Sensitization in Patients With Late Renal Graft Failure
Led by Hospital Universitari Vall d'Hebron Research Institute · Updated on 2024-11-06
202
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to compare the degree of HLA sensitization at 2 years in patients with late renal graft failure (\> 3 months) when receiving reduced immunosuppressant treatment versus stopping immunosuppression at 6 months. The main question this study aims to answer is: Does maintaining long-term immunosuppression in patients with a late renal graft failure (\> 3 months) safely reduce the risk of HLA sensitization? To answer this question, patients will be assigned to a control arm or investigational arm: * Patients assigned to the control arm will receive standard treatment, in which immunosuppressant treatment is withdrawn after 6 months. * Patients assigned to the investigatonal arm will continue immunosuppressant treatment at low doses for 2 years. Patients recruited in this clinical trial will be followed for up to 2 years. During this time, patients will visit the clinic every 3 months for checkups and tests.
CONDITIONS
Official Title
Study to Compare the Outcome of Receiving Continued Immunosuppression Versus Stopping Immunosuppression at 6 Months to Safely Prevent Human Leukocyte Antigen (HLA) Sensitization in Patients With Late Renal Graft Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide written informed consent
- Aged over 18 years
- Received at least one previous kidney transplant
- Kidney graft failure lasting at least 3 months
- On dialysis (hemodialysis or peritoneal) for 6 months or less
- Taken continuous immunosuppressive treatment with tacrolimus or cyclosporine and steroids since dialysis restart
- Candidates for relisting on deceased donor kidney transplant list as per physician
- Currently taking tacrolimus or cyclosporine
- cPRA at randomization less than or equal to 90%
You will not qualify if you...
- Received another solid organ transplant (liver, lung, heart, or pancreas)
- Waiting for a living related or unrelated kidney transplant
- Kidney graft survival less than 3 months
- On dialysis for more than 6 months at randomization
- Not meeting criteria to relist for transplant by physician
- Pregnant women
- Females of childbearing age not using or planning to use acceptable birth control during the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitario Vall D'Hebron
Barcelona, Spain, 0835
Actively Recruiting
Research Team
F
Francesc Moreso, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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