Renal Failure , ChronicPhase 4NCT06676696
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 study testing Continue low dose calcineurin inhibitor (CNI) and Calcineurin inhibitor withdrawal at 6 months in people with Renal Failure , Chronic and Graft Failure, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure , Chronic, Graft Failure, Graft Rejection
- What is being tested?
- Continue low dose calcineurin inhibitor (CNI) and Calcineurin inhibitor withdrawal at 6 months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jan 2024to 31 Jan 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Vall D'Hebron
Barcelona, 0835
Francesc Moreso, MD, PhD, +34 93 489 30 00, francescjosep.moreso@vallhebron.cat
About this study
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
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:
Read more
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
- Being tested
- Continue low dose calcineurin inhibitor (CNI), Calcineurin inhibitor withdrawal at 6 months
- Keywords
- Renal failure, immunosuppressor, HLA sensitization, Graft failure, Calcineurin inhibitors
- Medical subject headings
- Renal Insufficiency, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Calcineurin inhibitor withdrawal at 6 monthsDrug
CNI dose (tacrolimus or cyclosporine) will be reduced to one-half on month 3 visit and completely withdrawn on month 6 visit.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Not described Receives: Drug: Calcineurin inhibitor withdrawal at 6 months |
| Investigational arm | Active comparator | Not described Receives: Drug: Continue low dose calcineurin inhibitor (CNI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of HLA sensitization
The difference between the two treatment arms in the degree of HLA sensitization at 2-years measured as cPRA (%).
Measured: 2 years
Secondary outcomes (13)
Mortality for any reason
The difference between the two treatment arms at 2-years on mortality for any reason
Measured: 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
Measured: 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
Measured: 2 years
Percentage of patients transplanted
The difference between the two treatment arms at 2-years on percentage of patients transplanted
Measured: 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
Measured: 2 years
Incidence of infection
The difference between the two treatment arms at 2-years on incidence of infection
Measured: 2 years
Incidence of cardiovascular events
The difference between the two treatment arms at 2-years on incidence of cardiovascular events
Measured: 2 years
Incidence of cancer
The difference between the two treatment arms at 2-years on incidence of cancer
Measured: 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
Measured: 2 years
Erythropoietin resistance index
The difference between the two treatment arms at 2-years on erythropoietin resistance index
Measured: 2 years
Residual renal function
The difference between the two treatment arms at 2-years on residual renal function
Measured: 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
Measured: 2 years
Adverse events
The difference in the incidence of adverse events (AE) in the two treatment arms
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start22 Jan 2024
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure , ChronicStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676696
- Sponsor's protocol ID
- PREVSENSI
- Other IDs
- 2023-506879-98-00, 2023
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06676696
- Acronym / sponsor ID
- PREVSENSI
- Conditions
- Renal Failure , Chronic, Graft Failure, Graft Rejection, Allograft, Renal Failure Chronic Requiring Dialysis
- Keywords
- Renal failure, immunosuppressor, HLA sensitization, Graft failure, Calcineurin inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Drug: Calcineurin inhibitor withdrawal at 6 months |
| Investigational arm | Active comparator | Drug: Continue low dose calcineurin inhibitor (CNI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Investigational arm |
| Calcineurin inhibitor withdrawal at 6 monthsCNI dose (tacrolimus or cyclosporine) will be reduced to one-half on month 3 visit and completely withdrawn on month 6 visit. | Drug | Control Arm |
Primary outcome
Degree of HLA sensitization
Time frame: 2 years
The difference between the two treatment arms in the degree of HLA sensitization at 2-years measured as cPRA (%).
13 secondary outcomes
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
Adverse events
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continue low dose calcineurin inhibitor (CNI) and Calcineurin inhibitor withdrawal at 6 months in people with Renal Failure , Chronic and Graft Failure, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesc Moreso, MD, PhD (93 489 30 00, francescjosep.moreso@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of HLA sensitization (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.