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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

NCT06676696 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2024-11-06

No results posted yet for this 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* Patients assigned to the control arm will receive standard treatment, in which immunosuppressant treatment is withdrawn after 6 months.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.

Conditions

  • Renal Failure , Chronic
  • Graft Failure
  • Graft Rejection
  • Allograft
  • Renal Failure Chronic Requiring Dialysis

Interventions

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CNI dose (tacrolimus or cyclosporine) will be reduced to one-half on month 3 visit and completely withdrawn on month 6 visit.

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-22
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06676696 on ClinicalTrials.gov