Status:
WITHDRAWN
KidneyCare Immuno-optimization in Renal Allografts (KIRA)
Lead Sponsor:
CareDx
Conditions:
Kidney Transplant
Immunosuppression
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
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) surv...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05423496
Start Date
August 1 2022
End Date
February 23 2023
Last Update
March 27 2023
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