Stopping calcineurin inhibitors in kidney transplant recipients with no HLA-DQ mismatch
Safety of Calcineurin-Inhibitor Withdrawal in Zero-HLA DQ-Mismatched Kidney Transplant Recipients on a Concentration Controlled Mycophenolate Dose: A Prospective, Single Arm Pilot Study
This study is testing if kidney transplant patients with a good match can safely stop taking calcineurin inhibitors while adjusting their other medications to see how it affects their kidney health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Edegem, Antwerp) |
| Trial ID | NCT06493526 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether it is safe to withdraw calcineurin-inhibitor therapy in kidney transplant recipients who have a low risk of rejection due to a good HLA match. The study involves optimizing the dose of mycophenolate mofetil and corticosteroids before tapering off the calcineurin inhibitors over a four-week period. The primary focus is to assess the incidence of biopsy-proven rejection six months after the withdrawal, along with secondary outcomes related to kidney function and tolerability of the treatment regimen.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have received a first kidney transplant with no HLA-DQ mismatch between 3 to 12 months prior.
Not a fit: Patients who have had previous transplants, show signs of pre-existing immunity, or have a mismatch in HLA-DQ will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective immunosuppressive strategies for kidney transplant recipients.
How similar studies have performed: While this approach is novel, similar studies have shown promise in optimizing immunosuppressive therapy in transplant recipients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Eurotransplant Match determinant for DQB1 * Maintenance immunosuppressive therapy should consist of a calcineurin-inhibitor (tacrolimus or cyclosporine), MMF and corticosteroids * subjects 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) Exclusion Criteria: * 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 MMF treatment. Female patients who can get pregnant must use at least one reliable form of contraception before, during and for 6 weeks after stopping MMF treatment)
Where this trial is running
Edegem, Antwerp
- University Hospital Antwerp — Edegem, Antwerp, Belgium (Recruiting)
Study contacts
- Principal investigator: Rachel Hellemans, MD PhD — Antwerp University Hospital, Department of Nephrology, Drie Eikenstraat 655, 2650 Edegem, BELGIUM
- Study coordinator: Rachel Hellemans, MD PhD
- Email: rachel.hellemans@uza.be
- Phone: +3238213435
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.