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 | Recruiting Phase 4 DMC

• 2 other identifiers: PREVSENSI2023-506879-98-00
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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• Patients assigned to the control arm will receive standard treatment, in which immunosuppressant treatment is withdrawn after 6 months.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

Keywords

Renal failure; immunosuppressor; HLA sensitization; Graft failure; Calcineurin inhibitors

Outcome Measures

Primary Outcomes (1)

• Degree of HLA sensitization

  The difference between the two treatment arms in the degree of HLA sensitization at 2-years measured as cPRA (%).

  2 years

Secondary Outcomes (13)

• Mortality for any reason

  2 years

• Days of hospitalization for any reason

  2 years

• Percentage of patients effectively relisted during follow-up

  2 years

• Percentage of patients transplanted

  2 years

• Percentage of patients delisted for any reason

  2 years

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Drug: Calcineurin inhibitor withdrawal at 6 months

Investigational arm

ACTIVE COMPARATOR

Drug: Continue low dose calcineurin inhibitor (CNI)

Interventions

Continue low dose calcineurin inhibitor (CNI) DRUG

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

Investigational arm

Calcineurin inhibitor withdrawal at 6 months DRUG

CNI dose (tacrolimus or cyclosporine) will be reduced to one-half on month 3 visit and completely withdrawn on month 6 visit.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitario Vall D'Hebron

Barcelona, 0835, Spain

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Renal Insufficiency

Interventions

Calcineurin Inhibitors

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Francesc Moreso, MD, PhD

CONTACT

93 489 30 00; francescjosep.moreso@vallhebron.cat

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 6, 2024
• Study Start: January 22, 2024
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: November 6, 2024

Record last verified: 2024-11

Locations

ES (1)