Comparing 4 approaches for rejection
Official title: A Multicenter Randomized Controlled Trial to Treat Acute T Cell Mediated Rejection in Kidney and Kidney-Pancreas Transplant Recipients
A Multicenter Randomized Controlled Trial to Treat Acute t Cell Mediated Rejection in Kidney and Kidney-pancreas Transplant Recipients
- Phase 3
- 4 groups
- Sites in Calgary, Edmonton and 8 more cities
- Recruiting
Interventions
- Medication
Methylprednisolone
IV Methylprednisolone
- Medication
Prednisone
Oral prednisone augmentation
Canadian Sites (18)
18 listed, none recruiting
- Not yet recruiting
Foothills Medical Centre
Calgary, Alberta
- Not yet recruiting
Alberta Children's Hospital
Calgary, Alberta
- Not yet recruiting
Stollery Children's Hospital
Edmonton, Alberta
- Not yet recruiting
University of Alberta Hospital
Edmonton, Alberta
- Not yet recruiting
BC Children's Hospital
Vancouver, British Columbia
- Not yet recruiting
HSC Winnipeg Children's
Winnipeg, Manitoba
- Not yet recruiting
Health Sciences Center, University of Manitoba
Winnipeg, Manitoba
- Not yet recruiting
QEII Health Sciences Centre, Nova Scotia Health Authority
Halifax, Nova Scotia
- Not yet recruiting
London Health Science Centre
London, Ontario
- Not yet recruiting
St Mike's Hospital (Unity Health)
Toronto, Ontario
- Not yet recruiting
University of Toronto - Hospital for Sick Kids
Toronto, Ontario
- Not yet recruiting
Toronto General Hospital Research Institute (UHN)
Toronto, Ontario
- Not yet recruiting
Centre Hospitalier de l'université de Montréal (CHUM)
Montreal, Quebec
- Not yet recruiting
Glen Site
Montreal, Quebec
- Not yet recruiting
CHU Ste-Justine
Montreal, Quebec
- Not yet recruiting
Montreal Children's Hospital
Montreal, Quebec
- Not yet recruiting
CHU de Quebec
Québec, Quebec
- Not yet recruiting
St. Paul's Hospital
Saskatoon, Saskatchewan
Eligibility Criteria
See who this study is looking for18 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Participants or their legal guardian must be able to understand and provide written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →;
- +Stated willingness to comply with all study procedures and availability for the duration of the study;
- +All ethnic and gender groups will have equal access to the study;
- +All children (aged 2+ years) and adults who have received a kidney or SPK transplant with biopsy proven \*acute TCMR (≥ Banff borderline (minimum i1 score) whether clinical or subclinical).
- +Individuals with the following are eligible for inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →:
- +i. Concurrent acute TCMR and microvascular inflammation (MVI) defined as g+ptc, but without ABMR diagnosis.
- +ii. Concurrent acute TCMR and chronic active TCMR.
Exclusion
- −Individuals meeting any of the following criteria will be excluded from participation:
- −Mixed rejection.
- −Active or chronic active ABMR.
- −Chronic active TCMR.
- −Isolated v1 without inflammation.
- −Concurrent renal disease, such as recurrent glomerulonephritis or polyomavirus nephropathy.
- −Active malignancies or active infection that preclude immunosuppression augmentation.
- −Use of other immunomodulatory agents, including, but not limited to, Rituximab, Anti-TNF monoclonal antibody, Belatacept, Abatacept, Janus kinase inhibitors, Eculizumab, Pegcetacoplan.
- −EnrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → in other interventionalInterventional studyA study where participants are given something to see what happens.Read more → drug trials.
- −Use of other investigational agents.
- −Unable to adhere to the study protocolProtocolThe detailed plan a study must follow.Read more →.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 4 groups in this study.
Groups A and B receive Methylprednisolone and Prednisone.
Registry label: A: Lower dose IV methylprednisolone x Lower dose oral prednisone · B: Lower dose IV methylprednisolone x Higher dose oral prednisone
Groups C and D, the comparison group, receive Methylprednisolone and Prednisone.
Registry label: C: Higher dose IV methylprednisolone x lower dose oral prednisone · D: Higher dose IV methylprednisolone x higher dose oral prednisone
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 2 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 540 people.
The study is currently expected to finish around June 2030.
The main measurement is taken over: 12 weeks post-randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Histological resolution of biopsy-proven acute rejection — measured over 12 weeks post-randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
Improvement in allograft function for clinical rejection; and defined by an average of at least 2 serum creatinine at baselineBaselineYour starting measurements, taken before treatment begins.Read more → and at least 2 serum creatinine from 11-13 weeks — measured over 11 to 13 weeks post-randomization.
Avoidance of rescue therapies within 12 weeks post-randomization to achieve histological resolution and/or improvement in allograft function — measured over 12 weeks post-randomization.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06474273 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About MethylprednisoloneDrug
IV Methylprednisolone
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PrednisoneDrug
Oral prednisone augmentation
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 2 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 2 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 12 weeks post-randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
The study as a whole is currently expected to finish around 2030-06.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 540 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 10 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Halifax, Nova Scotia, Canada; London, Ontario, Canada, and 4 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
After a kidney or a kidney-pancreas transplant, some patients may face problems with their new organs. This happens because the body sometimes makes a mistake and tries to get rid of the organ. This problem is called rejection. One type of rejection is known as Acute T cell mediated rejection (TCMR). This can lead to many problems or even stop the transplant from working. Doctors give strong steroids to treat this problem, but there are no rules for how much steroid to give. Too much steroids can cause problems like heart and bone problems, bad infections, and weight gain. That is why we need to find the right dose of steroids for each person to treat this. TACKLE-IT is a study that will try to find the right steroid dose for treating rejection.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.