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Compares treatment options for Renal Failure , Chronic
Official title 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
What this study is testing
What is Continue low dose calcineurin inhibitor (CNI)?
Continue low dose calcineurin inhibitor (CNI) is an investigational medicine, being studied as a potential treatment for renal failure , chronic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Patients already relisted or candidates to relist to deceased donor kidney transplantation according to the treating physician criteria
You likely can't join 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
See the full eligibility 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...
- 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%
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.