Mycophenolate-Based Therapy for Kidney Transplant Recipients Without HLA-DQ Mismatch
NCT Number: NCT06493526
Acronym: MyQURE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Kidney Transplantation
Interventions: DRUG: Withdrawal of calcineurin-inhibitor, continue on concentration-controlled mycophenolate mofetil and corticosteroids.
Sponsor: University Hospital, Antwerp
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2027-06-30
Locations: University Hospital Antwerp, Edegem, Antwerp, 2650, Belgium

Summary:
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?

Primary Outcome Measures: Incidence of biopsy proven rejection, Biopsy will be performed as clinically indicated, or in case DSA develop (directed against HLA -A, HLA-B, HLA-DR or HLA-DQ with a MFI \> 500 and remaining present in a repeated test after 6 weeks (± 2 weeks)) to exclude subclinical rejection., at 26 weeks after CNI withdrawal
Secondary Outcome Measures: Incidence of biopsy proven rejection, Biopsy will be performed as clinically indicated, or in case DSA develop (directed against HLA -A, HLA-B, HLA-DR or HLA-DQ with a MFI \> 500 and remaining present in a repeated test after 6 weeks (± 2 weeks)) to exclude subclinical rejection., at 14 weeks and 1 year after CNI withdrawal|Incidence of de novo donor specific HLA antibodies (dnDSA), • HLA antibody testing (Luminex SAB): at baseline (unless performed \< 6 weeks ago), day 98, day 182, day 364 (and in case of suspected rejection), at 14 weeks, 26 weeks and 1 year after CNI withdrawal|Tolerability of MMF in the defined range, Gastro-intestinal Symptom Rating Scale and Adverse events, up to 1 year after CNI withdrawal|Change in eGFR, eGFR (CKDepi-cystatine formula), Comparing day 0 (day of CNI withdrawal) to 14 weeks, 26 weeks and 1 year after CNI withdrawal|Change in creatinine clearance, 24h creatinine clearance, Comparing day 0 (day of CNI withdrawal) to 14 weeks, 26 weeks and 1 year after CNI withdrawal|Change in albuminuria, Albuminuria in mg/day, Comparing day 0 to 14 weeks, 26 weeks and 1 year after CNI withdrawal|Change in albumin/creatinine ratio in urine, Albumine/creatinine ratio in urine, Comparing day 0 to 14 weeks, 26 weeks and 1 year after CNI withdrawal|Change in beta-2 microglobulinuria, beta-2 microglobulinuria in mg/day, Comparing day 0 to 14 weeks, 26 weeks and 1 year after CNI withdrawal|Change in beta-2 microglobulin/creatinine ratio in urine, beta-2 microglobuline/creatinine ratio in urine, Comparing day 0 to 14 weeks, 26 weeks and 1 year after CNI withdrawal|Change in arterial hypertension, Blood pressure in mmHg, Comparing baseline to 1 year after CNI withdrawal|Change in number of antihypertensive drugs, number of antihypertensive drugs, Comparing baseline to 1 year after CNI withdrawal|Change in serum total cholesterol, total cholesterol levels (mg/dl), Comparing baseline to 1 year after CNI withdrawal|Change in serum LDL cholesterol, LDL cholesterol levels (mg/dl), Comparing baseline to 1 year after CNI withdrawal|Change in serum HDL cholesterol, HDL cholesterol levels (mg/dl), Comparing baseline to 1 year after CNI withdrawal|Change in serum fasting triglycerides, fasting triglyceride levels (mg/dl), Comparing baseline to 1 year after CNI withdrawal|Change in need for statin therapy, type and dose of statin therapy, Comparing baseline to 1 year after CNI withdrawal|Change in HbA1C, HbA1C (%), Comparing baseline to 1 year after CNI withdrawal|Change in need for antidiabetic medication, number and type of antidiabetic drugs, Comparing baseline to 1 year after CNI withdrawal|Change in fasting glucose levels, fasting glucose level (mg/dL), Comparing baseline to 1 year after CNI withdrawal|Change in body weight, Body weight in kg, Comparing baseline to 1 year after CNI withdrawal