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Kidney TransplantationPhase 4MyQURENCT06493526

Mycophenolate-Based Therapy for Kidney Transplant Recipients Without HLA-DQ Mismatch

A Phase 4 study of Kidney Transplantation, run by University Hospital, Antwerp at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Transplantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteBelgium
Study dates
20 Aug 2024to 30 Jun 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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)

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rachel Hellemans, MD PhD contact

+3238213435

rachel.hellemans@uza.be

Hans de Fijter, MD PhD contact

+3238213435

nefrologie@uza.be

Belgium1 site, 1 recruiting

  • University Hospital Antwerp

    Edegem, Antwerp, 2650

    Rachel Hellemans, MD PhD, +3238213435, rachel.hellemans@uza.be

    Rachel Hellemans, MD PhD

    Recruiting

Other trials in Belgium

About this study

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

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?

Read the detailed description

In summary, this pilot, prospective, single-arm open interventional study the investigators will include immune-quiescent zero-DQ mismatched kidney transplant recipients between 3-12 months post-transplant who are on a CNI-based regimen with corticosteroids and MMF. After optimization of MMF dose, targeted at an MPA AUC12 of 60 (±15) mg.h/L, CNIs will be tapered and stopped over a 4 week peri-od. Prednisolon dose will be temporarily increased to 10 mg/day at the day of CNI withdrawal for 14 days, and continued at 5 mg/d thereafter. The primary outcome is biopsy-proven rejection at 6 months after CNI withdrawal. Secondary outcomes will look at other markers of alloreactivity (dnD-SA without clinical or histological signs of rejection), tolerability of MMF in the defined range, infec-tious complications, and possible favorable effects of CNI withdrawal (on GFR, tubular function, blood pressure, lipid profile and diabetes).

Being tested
Withdrawal of calcineurin-inhibitor, continue on concentration-controlled mycophenolate mofetil and corticosteroids.
Keywords
mycophenolate mofetil, Calcineurin Inhibitor, calcineurin inhibitor withdrawal, HLA-DQ, rejection, area under the curve, withdrawal, pharmacokinetic, concentration-controlled, mismatches
Medical subject headings
Rejection, Psychology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Withdrawal of calcineurin-inhibitor, continue on concentration-controlled mycophenolate mofetil and corticosteroids.Drug

    Mycophenolate mofetil dose will be optimized to an AUC12 of 60 h.mg/L, thereafter the calcineurin inhibitor will be withdrawn.

Study groups in NCT06493526
Study groupRoleWhat they receive
Withdrawal of calcineurin-inhibitors in zero-HLA DQ-mismatched kidney transplant recipientsExperimentalcalcineurin-inhibitor withdrawal, continue on a concentration controlled mycophenolate dose (AUC12 target 60 h.mg/L)
Receives: Drug: Withdrawal of calcineurin-inhibitor, continue on concentration-controlled mycophenolate mofetil and corticosteroids.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at 26 weeks after CNI withdrawal

Secondary outcomes (20)

  1. 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.

    Measured: at 14 weeks and 1 year after CNI withdrawal

  2. 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)

    Measured: at 14 weeks, 26 weeks and 1 year after CNI withdrawal

  3. Tolerability of MMF in the defined range

    Gastro-intestinal Symptom Rating Scale and Adverse events

    Measured: up to 1 year after CNI withdrawal

  4. Change in eGFR

    eGFR (CKDepi-cystatine formula)

    Measured: Comparing day 0 (day of CNI withdrawal) to 14 weeks, 26 weeks and 1 year after CNI withdrawal

  5. Change in creatinine clearance

    24h creatinine clearance

    Measured: Comparing day 0 (day of CNI withdrawal) to 14 weeks, 26 weeks and 1 year after CNI withdrawal

  6. Change in albuminuria

    Albuminuria in mg/day

    Measured: Comparing day 0 to 14 weeks, 26 weeks and 1 year after CNI withdrawal

  7. Change in albumin/creatinine ratio in urine

    Albumine/creatinine ratio in urine

    Measured: Comparing day 0 to 14 weeks, 26 weeks and 1 year after CNI withdrawal

  8. Change in beta-2 microglobulinuria

    beta-2 microglobulinuria in mg/day

    Measured: Comparing day 0 to 14 weeks, 26 weeks and 1 year after CNI withdrawal

  9. Change in beta-2 microglobulin/creatinine ratio in urine

    beta-2 microglobuline/creatinine ratio in urine

    Measured: Comparing day 0 to 14 weeks, 26 weeks and 1 year after CNI withdrawal

  10. Change in arterial hypertension

    Blood pressure in mmHg

    Measured: Comparing baseline to 1 year after CNI withdrawal

  11. Change in number of antihypertensive drugs

    number of antihypertensive drugs

    Measured: Comparing baseline to 1 year after CNI withdrawal

  12. Change in serum total cholesterol

    total cholesterol levels (mg/dl)

    Measured: Comparing baseline to 1 year after CNI withdrawal

  13. Change in serum LDL cholesterol

    LDL cholesterol levels (mg/dl)

    Measured: Comparing baseline to 1 year after CNI withdrawal

  14. Change in serum HDL cholesterol

    HDL cholesterol levels (mg/dl)

    Measured: Comparing baseline to 1 year after CNI withdrawal

  15. Change in serum fasting triglycerides

    fasting triglyceride levels (mg/dl)

    Measured: Comparing baseline to 1 year after CNI withdrawal

  16. Change in need for statin therapy

    type and dose of statin therapy

    Measured: Comparing baseline to 1 year after CNI withdrawal

  17. Change in HbA1C

    HbA1C (%)

    Measured: Comparing baseline to 1 year after CNI withdrawal

  18. Change in need for antidiabetic medication

    number and type of antidiabetic drugs

    Measured: Comparing baseline to 1 year after CNI withdrawal

  19. Change in fasting glucose levels

    fasting glucose level (mg/dL)

    Measured: Comparing baseline to 1 year after CNI withdrawal

  20. Change in body weight

    Body weight in kg

    Measured: Comparing baseline to 1 year after CNI withdrawal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2024
  2. Study start20 Aug 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06493526
Sponsor's protocol ID
UZA-6402
Acronym
MyQURE
Status last verified
Jun 2024
First submitted
18 Jun 2024
Last updated
21 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study of Kidney Transplantation, run by University Hospital, Antwerp at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rachel Hellemans, MD PhD (+3238213435, rachel.hellemans@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of biopsy proven rejection (time frame: at 26 weeks after CNI withdrawal). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06493526.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.

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