Mycophenolate-Based Therapy for Kidney Transplant Recipients Without HLA-DQ Mismatch
- Conditions
- Kidney Transplantation
- Registration Number
- NCT06493526
- Lead Sponsor
- University Hospital, Antwerp
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br>In order to be eligible to participate in this study, a subject must meet all of the<br>following criteria:<br><br> - Adults = 18 years old who received a first, zero-HLA-DQ mismatched kidney transplant<br> between 3 and 12 months before screening. ((mis)matching based on the broad<br> Eurotransplant Match determinant for DQA1 and on the split Eurotransplant Match<br> determinant for DQB1<br><br> - Maintenance immunosuppressive therapy should consist of a calcineurin-inhibitor<br> (tacrolimus or cyclosporine), MMF and corticosteroids<br><br> - subjects capable of giving informed consent<br><br> - eGFR = 20 ml/min/1.73m² based on CKD-EPI Creatinine-Cystatin Equation at screening<br><br> - Recent HLA antibody testing (<6 weeks before screening)<br><br> - Absence of DSA (MFI > 500) at screening and in all historical samples<br><br> - Absence of subclinical rejection on a protocol kidney transplant biopsy according to<br> latest Banff criteria (excl. borderline lesions)<br><br> - Recent assessment of CNI and MPA AUC (performed at least 8 weeks after<br> transplantation, but <12 weeks before screening, )<br><br> - Recent OGTT in patients not on antidiabetic therapy (<3 months ago)<br><br>Exclusion Criteria:<br><br> - Receipt of a non-renal transplant<br><br> - HLA identical sibling donor transplant<br><br> - ABO incompatible kidney transplantation<br><br> - cdc-PRA at transplantation > 50%<br><br> - Ongoing treatment with immunosuppressive drugs other than CNI, MMF/MPA and<br> cortico-steroids<br><br> - Prophylactic therapy with valganciclovir<br><br> - History of biopsy-proven acute rejection<br><br> - Unexplained rise in creatininemia >20% over the last 6 weeks<br><br> - Albuminuria > 1g/day ( based on latest 24h urine collection max 6 weeks ago)<br><br> - Chronic diarrhea or gastrointestinal disorders that interfere with the absorption or<br> oral medi-cation<br><br> - Active peptic ulcer disease<br><br> - Active hepatitis B, hepatitis C or human immunodeficiency virus infection at the day<br> of trans-plantation<br><br> - New diagnosis of malignancy since transplantation, except successfully treated<br> nonmetastatic basal or squamous cell carcinoma of the skin<br><br> - Pregnancy or lactation<br><br> - Patients unwilling to use reliable anticonception during the study (Male patients or<br> their untreated female partner must use reliable contraception during my-cophenolate<br> treatment and for at least 90 days after stopping MMF treatment. Female patients who<br> can get pregnant must use at least one reliable form of contraception before, during<br> and for 6 weeks after stopping MMF treatment)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of biopsy proven rejection
- Secondary Outcome Measures
Name Time Method Incidence of biopsy proven rejection;Incidence of de novo donor specific HLA antibodies (dnDSA);Tolerability of MMF in the defined range;Change in eGFR;Change in creatinine clearance;Change in albuminuria;Change in albumin/creatinine ratio in urine;Change in beta-2 microglobulinuria;Change in beta-2 microglobulin/creatinine ratio in urine;Change in arterial hypertension;Change in number of antihypertensive drugs;Change in serum total cholesterol;Change in serum LDL cholesterol;Change in serum HDL cholesterol;Change in serum fasting triglycerides;Change in need for statin therapy;Change in HbA1C;Change in need for antidiabetic medication;Change in fasting glucose levels;Change in body weight