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Recruiting NCT06676696

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

Phase IV Interventional Renal Failure , Chronic Graft Failure Graft Rejection Allograft

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Continue low dose calcineurin inhibitor (CNI), Calcineurin inhibitor withdrawal at 6 months.
Who it may be relevant to
Registry conditions: Renal Failure , Chronic, Graft Failure, Graft Rejection, Allograft. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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arm: * Patients assigned to the control arm will receive standard treatment, in which immunosuppressant treatment is withdrawn after 6 months.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.

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.

Primary outcome measures

  • Degree of HLA sensitization [Time frame: 2 years]
Secondary outcome measures (12)
  • Mortality for any reason [Time frame: 2 years]
  • Days of hospitalization for any reason [Time frame: 2 years]
  • Percentage of patients effectively relisted during follow-up [Time frame: 2 years]
  • Percentage of patients transplanted [Time frame: 2 years]
  • Percentage of patients delisted for any reason [Time frame: 2 years]
  • Incidence of infection [Time frame: 2 years]
  • Incidence of cardiovascular events [Time frame: 2 years]
  • Incidence of cancer [Time frame: 2 years]
  • Incidence of graft-intolerance syndrome requiring graft nephrectomy or percutaneous embolization of the non-functioning graft [Time frame: 2 years]
  • Erythropoietin resistance index [Time frame: 2 years]
  • Residual renal function [Time frame: 2 years]
  • Number of circulating memory B-cells [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Patient must be able to understand and provide written informed consent
  • Patients older than 18 years who had received at least one previous renal transplant
  • Patients with a retained kidney graft failed for any reason which survived at least 3 months
  • Patients on dialysis, either hemodialysis or peritoneal dialysis. Patients can be on dialysis for a maximum of 6 months at the time of randomization, as long as the patients have taken an uninterrupted immunosuppressive regimen of calcineurin inhibitors (tacrolimus or cyclosporine) and steroids since dialysis was restarted
  • Patients already relisted or candidates to relist to deceased donor kidney transplantation according to the treating physician criteria
  • Patients taking immunosuppressants tacrolimus or cyclosporine
  • cPRA at the time of randomization ≤ 90%

Exclusion criteria

  • Patients who have received another solid organ transplantation (liver, lung, heart or pancreas)
  • Patients waiting for a living related / unrelated kidney transplant
  • Graft survival of the failed graft lower than 3 months
  • Patients in dialysis more than 6 months at the time of randomization
  • Patients not accomplishing criteria to relist in the transplantation list according to the treating physician criteria
  • Pregnant women
  • Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Patients should use one of the acceptable birth control measures recommended in the document "Recommendations related to contraception and pregnancy testing in clinical trials" published by the Clinical Trials Facilitation and Coordination Group (CTFG) (version 1.1, published 21/09/2020). Recommended birth control measures include oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, or sexual abstinence. If sexually active, the subject must have been using one of the accepted birth control methods at least one month prior to study entry.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Hospital Universitario Vall D'Hebron — Barcelona

Identifiers

NCT: NCT06676696 · PREVSENSI · 2023-506879-98-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗