Trials / Recruiting
RecruitingNCT06676696
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
A Multi-centre, Open, Prospective, Randomized, Parallel-group, 24-month 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
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 202 (estimated)
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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arm: * Patients assigned to the control arm will receive standard treatment, in which immunosuppressant treatment is withdrawn after 6 months.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.
Conditions
- Renal Failure , Chronic
- Graft Failure
- Graft Rejection
- Allograft
- Renal Failure Chronic Requiring Dialysis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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 |
| DRUG | 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at 6 months | CNI dose (tacrolimus or cyclosporine) will be reduced to one-half on month 3 visit and completely withdrawn on month 6 visit. |
Timeline
- Start date
- 2024-01-22
- Primary completion
- 2028-01-31
- Completion
- 2028-01-31
- First posted
- 2024-11-06
- Last updated
- 2024-11-06
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT06676696. Inclusion in this directory is not an endorsement.