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New treatment option for Rejection; Transplant, Kidney
Official title TACKLE-IT Trial - Treat Acute T Cell Rejection With Evidence and Confidence in Kidney Transplant Recipients
ClinicalTrials.gov ID: NCT06474273
What this study is testing
What is Methylprednisolone?
Methylprednisolone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for rejection; transplant, kidney.
Also referred to as IV MP.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- After a kidney or a simultaneous 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- Participants or their legal guardian must be able to understand and provide written informed consent;
- 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...
You likely can't join if
- Mixed rejection.
- Active or chronic active ABMR.
- Chronic active TCMR. \ Patients with concomitant acute TCMR and chronic active TCMR will not be excluded from the trial.
- Isolated v1 without inflammation.
- Concurrent renal disease, such as recurrent glomerulonephritis or polyomavirus nephropathy.
- Active malignancies or active infection that preclude immunosuppression augmentation.
See the full eligibility criteria
- Participants or their legal guardian must be able to understand and provide written informed consent;
- 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).
- Mixed rejection.
- Active or chronic active ABMR.
- Chronic active TCMR. \ Patients with concomitant acute TCMR and chronic active TCMR will not be excluded from the trial.
- 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.
- Enrolment in other treatment drug trials.
- Use of other investigational agents.
- Unable to adhere to the study protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Lambton, New South Wales, Australia
- Randwick, New South Wales, Australia
- Westmead, New South Wales, Australia
- South Brisbane, Queensland, Australia
- Woolloongabba, Queensland, Australia
- Adelaide, South Australia, Australia
- Clayton, Victoria, Australia
- Nedlands, Western Australia, Australia
- Perth, Western Australia, Australia
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Winnipeg, Manitoba, Canada
- Halifax, Nova Scotia, Canada
- London, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
- Saskatoon, Saskatchewan, Canada
- Grafton, Auckland, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lambton, New South Wales, Australia; Randwick, New South Wales, Australia; Westmead, New South Wales, Australia; South Brisbane, Queensland, Australia; Woolloongabba, Queensland, Australia; Adelaide, South Australia, Australia and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.