Actively Recruiting
Mycophenolate-Based Therapy for Kidney Transplant Recipients Without HLA-DQ Mismatch
Led by University Hospital, Antwerp · Updated on 2024-08-21
20
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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? Is this approach well tolerated? Will this approach lead to better kidney function and/or other beneficial effects?
CONDITIONS
Official Title
Mycophenolate-Based Therapy for Kidney Transplant Recipients Without HLA-DQ Mismatch
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older who received a first kidney transplant with zero-HLA-DQ mismatch between 3 and 12 months before screening
- Receiving maintenance immunosuppressive therapy consisting of calcineurin-inhibitor (tacrolimus or cyclosporine), mycophenolate mofetil, and corticosteroids
- Able to provide informed consent
- Estimated glomerular filtration rate (eGFR) of at least 20 ml/min/1.73m² at screening
- Recent HLA antibody testing within 6 weeks before screening
- No donor-specific antibodies (DSA) with mean fluorescence intensity (MFI) over 500 at screening and in all past samples
- No subclinical rejection on recent protocol kidney biopsy (excluding borderline lesions)
- Recent assessment of calcineurin-inhibitor and mycophenolic acid area under the curve (AUC) between 8 weeks post-transplant and less than 12 weeks before screening
- Recent oral glucose tolerance test in patients not on antidiabetic therapy within 3 months before screening
You will not qualify if you...
- History of receiving a non-renal transplant
- Kidney transplant from an HLA-identical sibling donor
- ABO incompatible kidney transplant
- Panel reactive antibody (cdc-PRA) over 50% at transplantation
- Treatment with immunosuppressive drugs other than calcineurin-inhibitor, mycophenolate mofetil/mycophenolic acid, and corticosteroids
- Prophylactic therapy with valganciclovir
- History of biopsy-proven acute rejection
- Unexplained increase in creatinine level over 20% in the last 6 weeks
- Albuminuria over 1 gram per day based on recent 24-hour urine collection
- Chronic diarrhea or gastrointestinal disorders affecting absorption or oral medication
- Active peptic ulcer disease
- Active hepatitis B, hepatitis C, or HIV infection at the time of transplantation
- New diagnosis of malignancy since transplantation, except successfully treated non-metastatic basal or squamous cell skin cancer
- Pregnancy or breastfeeding
- Unwillingness to use reliable contraception during the study for male patients or their untreated female partners during and after mycophenolate treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
Research Team
R
Rachel Hellemans, MD PhD
CONTACT
H
Hans de Fijter, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here