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Kidney TransplantNCT05423496

KidneyCare Immuno-optimization in Renal Allografts (KIRA)

A study testing KidneyCare, steroid and MMF in people with Kidney Transplant and Immunosuppression, run by CareDx.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is an unblinded, randomized, four-arm interventional research study enrolling patients who are undergoing kidney transplantation. The aim of the study is to determine whether patients at low risk of rejection can safely reduce the doses of their post-transplant immunosuppression medications using a combination of… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Transplant, Immunosuppression, Allograft
What is being tested?
KidneyCare, steroid and MMF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Aug 2022to 23 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

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

  • Participant is willing and able to give informed consent for participation in the trial
  • Patients aged 18 years or older
  • cPRA <20% \& no preformed DSA at time of transplant (using center-specific threshold)
  • Recipient (or planned recipient, if pre-transplant) of single, first-time, deceased (DBD/DCD) or living donor Kidney Transplant
  • Planned post-transplant maintenance immunosuppression regimen consisting of tacrolimus and MMF, with or without prednisone
  • Negative virtual crossmatch (performed by transplant center)
  • Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception during the trial
  • In the Investigator's opinion, is able and willing to comply with all trial requirements

Who cannot join

  • The participant may not enter the trial if ANY of the following apply:
  • Female participant who is pregnant, lactating, or planning pregnancy during the trial
  • Preformed DSA or ABO incompatible transplant
  • Chronic oral steroid use (for any reason)
  • Planned post-transplant immunosuppression regimen utilizing cyclosporine, azathioprine, mTOR inhibitors, and/or co-stimulatory blockers
  • Donor organ from identical twin or history of prior kidney transplant
Show all 19Show fewer
  • Multivisceral transplant (heart/kidney, kidney/pancreas, liver/kidney, etc.) or history of hematopoietic stem cell transplant
  • Participant with life expectancy of less than 6 months or is inappropriate for immuno-optimization (including those patients at increased risk of primary disease recurrence w/ reduction in post-transplant immunosuppression)
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
  • Participants who are currently or have previously participated in another research trial involving an investigational drug/product in the past 12 weeks
  • Any condition that would preclude protocol biopsies (e.g. patients on lifelong anticoagulation for whom anticoagulation cannot be safely held)
  • Randomization Criteria (assessed at 3 months)
  • The participant may not proceed with randomization if ANY of the following apply:
  • Maintenance immunosuppression that includes cyclosporine, azathioprine, mTOR inhibitors, and/or co-stimulatory blockers
  • Baseline proteinuria ≥0.5g/day (confirmed by repeat measurement)
  • Baseline eGFR <45mL/min (average of 3 most recent prior readings)
  • Any episodes of biopsy-proven acute rejection (TCMR ≥1A or ABMR) since the time of transplant
  • Any interval detection of de novo DSA since the time of transplant (per center-specific threshold)
  • AlloSure result >0.5% at Month 3

About this study

Official title: KidneyCare Immuno-optimization in Renal Allografts

This is an unblinded, randomized, four-arm interventional research study enrolling patients who are undergoing kidney transplantation. The aim of the study is to determine whether patients at low risk of rejection can safely reduce the doses of their post-transplant immunosuppression medications using a combination of tests that include donor-specific antibodies (DSA), histology (looking at tissue from the donor graft), and donor-derived cell-free DNA (AlloSure). Eligible participants will be randomized in a 2:1 ratio into one of two immune-optimization (intervention) arms or the corresponding observational (control) arms. Two thirds of the participants in the study will have their decision to reduce immunosuppression made based on these test results and the other third will have the decision made based on standard of care clinical assessment and laboratory testing. The study will include two additional parameters under investigation - the AlloMap Kidney gene expression profiling test and the iBox prediction algorithm, but these will not be actively used to make any decisions as part of the trial. AlloSure, AlloMap Kidney, and iBox are the three components of the KidneyCare panel developed by CareDx.

Read the detailed description

This is a prospective, multicenter, open-label randomized controlled four-arm interventional trial of kidney transplant recipients receiving KidneyCare (AlloSure-Kidney, AlloMap Kidney, and iBox) surveillance testing. Eligible patients who meet inclusion/exclusion criteria and provide consent will undergo standard immune induction per their center protocol and begin a post-transplant maintenance regimen of tacrolimus and mycophenolate mofetil (MMF), with or without steroids after transplantation. If all prerequisite criteria are satisfied at 3 months, participants will be randomized and participants in the intervention arms will begin protocolized immuno-optimization, with the objective of the study being the gradual elimination of one immunosuppressive agent (either MMF or steroids) and optimization of calcineurin inhibitors (CNI) dosing. Any immune optimization changes in the control/observational arms will occur based on clinician discretion.

Being tested
KidneyCare, steroid, MMF
Keywords
Calcineurin inhibitors, allograft loss and survival, Chronic immunosuppression, Steroid avoidance, Low-risk kidney transplant recipients, Acute rejection, KidneyCare, Immunological risk assessment, Cross-match testing, Donor-specific antibodies, Donor-derived cell-free DNA, AlloSue, AlloMap, iBox, Gene expression profiling, HistoMap assay, Immune optimization

What participants receive

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

  • KidneyCareDiagnostic test

    Using KidneyCare platform as a tool to successfully augment immunosuppressant agents through regular surveillance allowing minimization of doses and number of agents.

  • steroidDrug

    optimization of steroids

  • MMFDrug

    optimization of MMF

Study groups in NCT05423496
Study groupRoleWhat they receive
Steroid Control ArmActive comparator133 patient undergoing KidneyCare Surveillance with Immune optimization at clinician discretion
Receives: Diagnostic Test: KidneyCare
Steroid Immuno-optimization ArmExperimental267 patient undergoing KidneyCare Surveillance with protocolized AlloSure-guided immuno-optimization of steroids/CNI
Receives: Diagnostic Test: KidneyCare; Drug: steroid
Tacrolimus and mycophenolate mofetil (MMF) Control ArmActive comparator133 patient undergoing KidneyCare Surveillance with Immune optimization at clinician discretion
Receives: Diagnostic Test: KidneyCare
MMF Immuno-optimization ArmExperimental267 patient undergoing KidneyCare Surveillance with protocolized AlloSure-guided immuno-optimization of MMF/CNI
Receives: Diagnostic Test: KidneyCare; Drug: MMF

What is being measured

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

  1. Estimated glomerular filtration rate (eGFR) at 12 months, non-inferiority

    Demonstrate the safety and efficacy of KidneyCare as tool to successfully adjust immunosuppressant agents using regular surveillance for safe drug minimization. (safety endpoint)

    Measured: 12 months

  2. Estimated glomerular filtration rate (eGFR) at 24 months, non-inferiority

    Demonstrate the safety and efficacy of KidneyCare as tool to successfully adjust immunosuppressant agents using regular surveillance for safe drug minimization. (safety endpoint)

    Measured: 24 months

  3. Interstitial fibrosis/tubular atrophy (IF/TA) quantified by Banff Working Group biopsy grade(s) at 12-months post-transplant

    Demonstrate the safety and efficacy of KidneyCare as tool to successfully adjust immunosuppressant agents using regular surveillance for safe drug minimization. (safety)

    Measured: 12 months

  4. Interstitial fibrosis/tubular atrophy (IF/TA) quantified by Banff Working Group biopsy grade(s) at 24-months post-transplant

    Demonstrate the safety and efficacy of KidneyCare as tool to successfully adjust immunosuppressant agents using regular surveillance for safe drug minimization. (safety)

    Measured: 24 months

  5. Transplant glomerulopathy (TG) at 12-months post-transplant, quantified by biopsy-based histopathology grade(s)

    Demonstrate the safety and efficacy of KidneyCare as tool to successfully adjust immunosuppressant agents using regular surveillance for safe drug minimization. (safety)

    Measured: 12 months

  6. Transplant glomerulopathy (TG) at 24-months post-transplant, quantified by biopsy-based histopathology grade(s)

    Demonstrate the safety and efficacy of KidneyCare as tool to successfully adjust immunosuppressant agents using regular surveillance for safe drug minimization. (safety)

    Measured: 24 months

  7. Total number of biopsies performed post-transplant, including both surveillance and clinically indicated biopsies

    Demonstrate the safety and efficacy of KidneyCare as tool to successfully adjust immunosuppressant agents using regular surveillance for safe drug minimization. (efficacy)

    Measured: 24 months

  8. Number of clinically indicated biopsies planned and performed in the first 12- months post- transplant

    Demonstrate the safety and efficacy of KidneyCare as tool to successfully adjust immunosuppressant agents using regular surveillance for safe drug minimization. (efficacy)

    Measured: 12 months

  9. Number of clinically indicated biopsies planned and performed in the 24-months post- transplant

    Demonstrate the safety and efficacy of KidneyCare as tool to successfully adjust immunosuppressant agents using regular surveillance for safe drug minimization. (efficacy)

    Measured: 24 months

Secondary outcomes (2)

  1. Histological assessment of tissue biopsy with paired AlloSure dd-cfDNA result - performed both 'For Cause' and 'Surveillance', using standard biopsy and HistoMap molecular assessment using nCounter.

    Identify correlation between dd-cfDNA and histopathological allograft rejection based on all clinical biopsies.

    Measured: 24 months

  2. Results of DSA testing, performed as outlined in the testing schedule

    Compare rates of de-novo DSA antibody formation in immuno-optimization and control groups.

    Measured: 24 months

Timeline

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

  1. First posted21 Jun 2022
  2. Study startAug 2022 (estimated)
  3. Primary completion23 Feb 2023 (estimated)
  4. Study completion23 Feb 2023 (estimated)

Why it stopped: Business decision based on clinical utility considerations

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05423496
Sponsor's protocol ID
SN-C-00013
Status last verified
Mar 2023
First submitted
31 May 2022
Last updated
27 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing KidneyCare, steroid and MMF in people with Kidney Transplant and Immunosuppression, run by CareDx.

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 8 inclusion and 19 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: withdrawn, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimated glomerular filtration rate (eGFR) at 12 months, non-inferiority (time frame: 12 months). The study lists 9 primary outcomes in all. 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 NCT05423496.

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 27 Mar 2023.

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