BridgeMD
New treatment option for Kidney Transplantation
Official title Mycophenolate-Based Therapy for Kidney Transplant Recipients Without HLA-DQ Mismatch
ClinicalTrials.gov ID: NCT06493526
What this study is testing
What is Withdrawal of calcineurin-inhibitor, continue on concentration-controlled mycophenolate mofetil and corticosteroids.?
Withdrawal of calcineurin-inhibitor, continue on concentration-controlled mycophenolate mofetil and corticosteroids. is an investigational medicine, being studied as a potential treatment for kidney transplantation.
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 learn if calcineurin-inhibitor therapy (a drug commonly used to prevent rejection) can be safely stopped in kidney transplant recipients with a relatively low risk of rejection (being recipients of a first transplant, without any signs of pre-existing immunity against the graft, and having a good HLA match with the donor (no mismatch in HLA-DQ)). Before stopping the calcineurin-inhibitors, the remaining therapy with mycophenolate mofetil and corticosteroids will be optimized.The main questions it aims to answer are: Is this approach safe, in terms of preventing rejection?
- Phase 4: studies an already-approved treatment
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
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Adults ≥ 18 years old who received a first, zero-HLA-DQ mismatched kidney transplant between 3 and 12 months before screening. ((mis)matching based...
- Maintenance immunosuppressive therapy should consist of a calcineurin-inhibitor (tacrolimus or cyclosporine), MMF and corticosteroids
- people capable of giving informed consent
- eGFR ≥ 20 ml/min/1.73m² based on CKD-EPI Creatinine-Cystatin Equation at screening
You likely can't join if
- Receipt of a non-renal transplant
- HLA identical sibling donor transplant
- ABO incompatible kidney transplantation
- cdc-PRA at transplantation \> 50%
- Ongoing treatment with immunosuppressive drugs other than CNI, MMF/MPA and cortico-steroids
- Prophylactic therapy with valganciclovir
See the full eligibility criteria
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Adults ≥ 18 years old who received a first, zero-HLA-DQ mismatched kidney transplant between 3 and 12 months before screening. ((mis)matching based on the broad Eurotransplant Match determinant for DQA1 and on the split...
- Maintenance immunosuppressive therapy should consist of a calcineurin-inhibitor (tacrolimus or cyclosporine), MMF and corticosteroids
- people capable of giving informed consent
- eGFR ≥ 20 ml/min/1.73m² based on CKD-EPI Creatinine-Cystatin Equation at screening
- Recent HLA antibody testing (\<6 weeks before screening)
- Absence of DSA (MFI \> 500) at screening and in all historical samples
- Absence of subclinical rejection on a protocol kidney transplant biopsy according to latest Banff criteria (excl. borderline lesions)
- Recent assessment of CNI and MPA AUC (performed at least 8 weeks after transplantation, but \<12 weeks before screening, )
- Recent OGTT in patients not on antidiabetic therapy (\<3 months ago)
- Receipt of a non-renal transplant
- HLA identical sibling donor transplant
- ABO incompatible kidney transplantation
- cdc-PRA at transplantation \> 50%
- Ongoing treatment with immunosuppressive drugs other than CNI, MMF/MPA and cortico-steroids
- Prophylactic therapy with valganciclovir
- History of biopsy-proven acute rejection
- Unexplained rise in creatininemia \>20% over the last 6 weeks
- Albuminuria \> 1g/day ( based on latest 24h urine collection max 6 weeks ago)
- Chronic diarrhea or gastrointestinal disorders that interfere with the absorption or oral medi-cation
- Active peptic ulcer disease
- Active hepatitis B, hepatitis C or human immunodeficiency virus infection at the day of trans-plantation
- New diagnosis of malignancy since transplantation, except successfully treated nonmetastatic basal or squamous cell carcinoma of the skin
- Pregnancy or lactation
- Patients unwilling to use reliable anticonception during the study (Male patients or their untreated female partner must use reliable contraception during my-cophenolate treatment and for at least 90 days after stopping...
The study team makes the final eligibility decision.
Where it's taking place
- Edegem, Antwerp, Belgium
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Edegem, Antwerp, Belgium. 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.