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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06474273




Registration number
NCT06474273
Ethics application status
Date submitted
19/06/2024
Date registered
25/06/2024
Date last updated
15/06/2025

Titles & IDs
Public title
TACKLE-IT Trial - Treat Acute T Cell Rejection With Evidence and Confidence in Kidney Transplant Recipients
Scientific title
A Multicenter Randomized Controlled Trial to Treat Acute t Cell Mediated Rejection in Kidney and Kidney-pancreas Transplant Recipients
Secondary ID [1] 0 0
GWCT051274
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rejection; Transplant, Kidney 0 0
Rejection; Transplant, Pancreas 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Methylprednisolone
Treatment: Drugs - Prednisone

Experimental: Lower dose IV methylprednisolone x Lower dose oral prednisone - Lower dose IV MP (250 mg daily x 3 days in adults or 150 mg/m² daily x 3, or to a max 250 mg/dose in children (\<18 years), with lower dose (25mg daily x 7 days, or 15mg/m² for those \< 18 years ) oral prednisone augmentation then return to standard prednisone.

Experimental: Lower dose IV methylprednisolone x Higher dose oral prednisone - Lower dose IV MP (250 mg daily x 3 in adults or 150 mg/m² daily x 3, or to a max 250 mg/dose in children (\<18 years), with higher dose (50mg daily x 7 , or 30mg/m² daily x 7 for those \< 18 years) oral prednisone augmentation then return to standard prednisone.

Active comparator: Higher dose IV methylprednisolone x lower dose oral prednisone - Higher dose IV MP (500mg daily x 3 in adults or 300 mg/m² daily x 3 or to a max 500 mg/dose in children (\<18 years), with lower dose (25mg daily x 7 days, or 15mg/m² for those \< 18 years) oral prednisone augmentation then return to standard prednisone.

Active comparator: Higher dose IV methylprednisolone x higher dose oral prednisone - Higher dose IV MP (500 mg daily x 3 in adults or 300 mg/m² daily x 3 or to a max 500 mg/dose in children (\<18 years), with higher dose (50mg daily x 7 days, or 30mg/m² for those \< 18 years) oral prednisone augmentation, then return to standard prednisone.


Treatment: Drugs: Methylprednisolone
IV Methylprednisolone

Treatment: Drugs: Prednisone
Oral prednisone augmentation
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Histological resolution of biopsy-proven acute rejection
Timepoint [1] 0 0
12 weeks post-randomization
Primary outcome [2] 0 0
Improvement in allograft function
Timepoint [2] 0 0
12 weeks post-randomization
Primary outcome [3] 0 0
Avoidance of rescue therapies within 12 weeks post-randomization to achieve histological resolution and/or improvement in allograft function
Timepoint [3] 0 0
12 weeks post-randomization
Secondary outcome [1] 0 0
Estimated glomerular filtration rate (eGFR)
Timepoint [1] 0 0
At 12, 24 and 48 weeks post-randomization
Secondary outcome [2] 0 0
All cause death and death-censored graft loss
Timepoint [2] 0 0
At 12 weeks post-randomization
Secondary outcome [3] 0 0
Urine albumin: creatinine ratios
Timepoint [3] 0 0
At 12, 24 and 48 weeks post-randomization
Secondary outcome [4] 0 0
Quality of life (QoL)
Timepoint [4] 0 0
Baseline (at randomization), 12 weeks , 24 weeks , and 48 weeks post-randomization
Secondary outcome [5] 0 0
Cancer
Timepoint [5] 0 0
Anytime from randomization to 48 weeks
Secondary outcome [6] 0 0
Trajectories of serum creatinine changes
Timepoint [6] 0 0
From randomization to 48 weeks post-randomization
Secondary outcome [7] 0 0
Development of acute antibody mediated rejection (ABMR) and mixed rejection (concomitant ABMR + TCMR)
Timepoint [7] 0 0
48 weeks post-randomization
Secondary outcome [8] 0 0
Infections (including those requiring antimicrobials and hospitalisation)
Timepoint [8] 0 0
Anytime from randomization to 48 weeks post-randomization
Secondary outcome [9] 0 0
Development of chronic fibrosis in the allograft
Timepoint [9] 0 0
Baseline to 12 weeks post-randomization

Eligibility
Key inclusion 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).
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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 interventional drug trials.
* Use of other investigational agents.
* Unable to adhere to the study protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2030
Actual
Sample size
Target
540
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Hospital - Lambton
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 0 0
The Sydney Children's Hospital Network - Westmead
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [9] 0 0
Royal Perth Children's hospital - Nedlands
Recruitment hospital [10] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [11] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2305 - Lambton
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
2014 - South Brisbane
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment postcode(s) [9] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
Manitoba
Country [3] 0 0
Canada
State/province [3] 0 0
Nova Scotia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Canada
State/province [6] 0 0
Saskatchewan
Country [7] 0 0
New Zealand
State/province [7] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Manitoba
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Germaine Wong, PhD, FRACP
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Chandana Guha, MEcon
Address 0 0
Country 0 0
Phone 0 0
+61 9845 1229
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06474273