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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

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 ) vs higher dose (50mg daily x 7 days, or or 30mg/m2 for those \< 18 years) oral prednisone augmentation.

Experimental: Lower dose IV methylprednisolone x Higher 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 higher dose (50mg daily x 7 days, or or 30mg/m2 for those \< 18 years) oral prednisone augmentation.

Active comparator: Higher dose IV methylprednisolone x lower dose oral prednisone - Higher dose IV MP (500 mg daily x 3 days 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.

Active comparator: Higher dose IV methylprednisolone x higher dose oral prednisone - Higher dose IV MP (500 mg daily x 3 days 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.


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-randomisation 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
Trajectories of serum creatinine changes
Timepoint [4] 0 0
From randomization to 48 weeks
Secondary outcome [5] 0 0
Development of acute antibody mediated rejection (ABMR) and mixed rejection (concomitant ABMR + TCMR)
Timepoint [5] 0 0
48 weeks post randomization
Secondary outcome [6] 0 0
Development of chronic fibrosis in the allograft
Timepoint [6] 0 0
Baseline to 12 weeks post-randomisation
Secondary outcome [7] 0 0
Infections (requiring antimicrobials and hospitalisation)
Timepoint [7] 0 0
Anytime from randomization to 48 weeks
Secondary outcome [8] 0 0
Quality of life (QoL)
Timepoint [8] 0 0
At randomization, 12 weeks post-randomization, 24 weeks post-randomization, and 48 weeks post-randomization
Secondary outcome [9] 0 0
Infections (all types)
Timepoint [9] 0 0
Anytime from randomization to 48 weeks
Secondary outcome [10] 0 0
Cancer
Timepoint [10] 0 0
Anytime from randomization to 48 weeks

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.
* Higher grade acute TCMR, =Banff 2A.
* 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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 4
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
1/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2029
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 Children's Hospital Melbourne - Parkville
Recruitment hospital [10] 0 0
Royal Perth Children's hospital - Nedlands
Recruitment hospital [11] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [12] 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
3052 - Parkville
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment postcode(s) [10] 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
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
Canada
State/province [5] 0 0
Saskatchewan
Country [6] 0 0
New Zealand
State/province [6] 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
9845 1229
Fax 0 0
Email 0 0
chandana.guha@sydney.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data collected for the study, including individual patient data and a data dictionary that defines each field in the data set, will be made available as deidentified participant data to researchers who propose to use the data for individual patient data meta-analysis. Data will be shared following approval of the proposal by the corresponding author and a signed data access agreement, beginning 2 years following main publication.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
Study protocol, SAP, ICF will be provided 3 months after registration. The Clinical study report and code will be provided after completion of the trial.
Available to whom?
All IPD data arising from the trial will be shared 2 years after publication of the main results.
Available for what types of analyses?
How or where can data be obtained?


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