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
Condition(s) studied
Investigational drug(s) / intervention(s)
Continue low dose calcineurin inhibitor (CNI): CNI dose (tacrolimus or cyclosporine) will be adjusted to maintain low tacrolimus or cyclosporine whole blood trough levels from month 3 to month 24 or End of Study
Calcineurin inhibitor withdrawal at 6 months: CNI dose (tacrolimus or cyclosporine) will be reduced to one-half on month 3 visit and completely withdrawn on month 6 visit.
Study summary
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* Patients assigned to the control arm will receive standard treatment, in which immunosuppressant treatment is withdrawn after 6 months.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.
Eligibility
Primary outcome measure(s)
- Degree of HLA sensitization — 2 years
The difference between the two treatment arms in the degree of HLA sensitization at 2-years measured as cPRA (%).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospital Universitario Vall D'Hebron | Barcelona | Spain | Recruiting |
More Hospital Universitari Vall d'Hebron Research Institute trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06676696 on ClinicalTrials.gov ↗ ← All trials in Spain