RecruitingNCT06676696Updated Nov 6, 2024

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 Phase 4 interventional study of Continue low dose calcineurin inhibitor (CNI) and Calcineurin inhibitor withdrawal at 6 months in Renal Failure , Chronic, Graft Failure and Graft Rejection, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-06.

Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Phase 4, Interventional, and Treatment

From the registry’s dates

Registered 9 months after the study started (first participant enrolled Jan 2024, registered Nov 2024).
Started Jan 2024; still recruiting 2 years 8 months later.

Phase: Phase 4
Study type: Interventional
Enrollment: 202
Allocation: Randomized
Ages: 18 Years and older
Sex: All

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Patients assigned to the control arm will receive standard treatment, in which immunosuppressant treatment is withdrawn after 6 months.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

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

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Keywords

Renal failure
immunosuppressor
HLA sensitization
Graft failure
Calcineurin inhibitors

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's planned enrollment of 202 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 202 participants (estimated)

Study arms

Active comparator
Control Arm
Drug: Calcineurin inhibitor withdrawal at 6 months
Active comparator
Investigational arm
Drug: Continue low dose calcineurin inhibitor (CNI)

Interventions

DrugContinue 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
DrugCalcineurin 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.

What researchers measure

Primary outcomes

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

Secondary outcomes

Mortality for any reason
The difference between the two treatment arms at 2-years on mortality for any reason
Time frame: 2 years
Days of hospitalization for any reason
The difference between the two treatment arms at 2-years on days of hospitalization for any reason
Time frame: 2 years
Percentage of patients effectively relisted during follow-up
The difference between the two treatment arms at 2-years on percentage of patients effectively relisted during follow-up
Time frame: 2 years
Percentage of patients transplanted
The difference between the two treatment arms at 2-years on percentage of patients transplanted
Time frame: 2 years
Percentage of patients delisted for any reason
The difference between the two treatment arms at 2-years on percentage of patients delisted for any reason
Time frame: 2 years
Incidence of infection
The difference between the two treatment arms at 2-years on incidence of infection
Time frame: 2 years
Incidence of cardiovascular events
The difference between the two treatment arms at 2-years on incidence of cardiovascular events
Time frame: 2 years
Incidence of cancer
The difference between the two treatment arms at 2-years on incidence of cancer
Time frame: 2 years
Incidence of graft-intolerance syndrome requiring graft nephrectomy or percutaneous embolization of the non-functioning graft
The difference between the two treatment arms at 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
The difference between the two treatment arms at 2-years on erythropoietin resistance index
Time frame: 2 years
Residual renal function
The difference between the two treatment arms at 2-years on residual renal function
Time frame: 2 years
Number of circulating memory B-cells
The difference between the two treatment arms at 2-years on number of circulating memory B-cells
Time frame: 2 years
Adverse events
The difference in the incidence of adverse events (AE) in the two treatment arms
Time frame: 2 years

Study locations

1 of 1 sites recruiting

Hospital Universitario Vall D'Hebron
Barcelona, 0835, Spain
- Francesc Moreso, MD, PhD · Contact · francescjosep.moreso@vallhebron.cat · +34 93 489 30 00
Recruiting

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06676696
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Responsible party: Sponsor
First posted: Nov 6, 2024
Start date: Jan 22, 2024
Primary completion: Jan 31, 2028 (estimated)
Completion: Jan 31, 2028 (estimated)
Last update: Nov 6, 2024

Study contacts

Francesc Moreso, MD, PhD

Contact

francescjosep.moreso@vallhebron.cat

93 489 30 00

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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