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Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up

Stopping calcineurin inhibitors in kidney transplant recipients with no HLA-DQ mismatch

Official title: 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

Run by University Hospital, Antwerp · NCT06493526 · Data updated 2026-11-12

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.

More Kidney Transplantation trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment20 (estimated)
SponsorUniversity Hospital, Antwerp
Academic / other
Locations1 site (Edegem, Antwerp)
StatusRecruiting
StartedAugust 20, 2024
Main results expectedDecember 31, 2026
Study endsJune 30, 2027
Registry record updatedAugust 21, 2024
Trial IDNCT06493526 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While this approach is novel, similar studies have shown promise in optimizing immunosuppressive therapy in transplant recipients.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.