Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000252819
Ethics application status
Approved
Date submitted
23/02/2012
Date registered
29/02/2012
Date last updated
23/02/2024
Date data sharing statement initially provided
20/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled trial of intravenous immunoglobulin (IVIg) compared with pulse methyl-prednisolone for the treatment of chronic active antibody mediated rejection
Scientific title
A Randomised Controlled trial of intravenous immunoglobulin (IVIg) compared with pulse methyl-prednisolone in Renal Transplant recipients with chronic active antibody mediated rejection to determine histological change on biopsy
Secondary ID [1] 263061 0
Nil
Universal Trial Number (UTN)
Trial acronym
VIPAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic active antibody mediated rejection of the renal allograft 270796 0
Condition category
Condition code
Renal and Urogenital 270987 270987 0 0
Kidney disease
Inflammatory and Immune System 286123 286123 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment with intravenous methylprednisolone, 3 doses at 250mg/dose over 3 consecutive days and intravenous immunoglobulin (1gm/kg), 3 doses once per month over 3 months. The above is then repeated after 3 months if there is ongoing active rejection on follow-up biopsy. A further 2 biopsies are preformed at 6 and 12 months. Biopsies entail a local anaesthetic to the skin over the kidney and then passing a 14 gauge needle into the transplant kidney to remove a tiny core of tissue. The participant must stay in a day procedude facility for 4 hours after the procedure to monitor for complications such as bleeding. These are diagnostic procedure and are not therapeutic.
Intervention code [1] 269413 0
Treatment: Drugs
Comparator / control treatment
Treatment with intravenous methylprednisolone, 3 doses at 250mg/dose over 3 consecutive days. The above is then repeated after 3 months if there is ongoing active rejection on follow-up biopsy. A further 2 biopsies are preformed at 6 and 12 months.
Control group
Active

Outcomes
Primary outcome [1] 279653 0
chronic allograft damage index (CADI score)
Timepoint [1] 279653 0
12 months
Secondary outcome [1] 294129 0
change in renal function (GFR)
Timepoint [1] 294129 0
12 months
Secondary outcome [2] 294130 0
graft loss as determined by a return to dialysis or death.
Timepoint [2] 294130 0
during follow-up period (indefinite)
Secondary outcome [3] 294131 0
patient survival as assessed by patients vital status.
Timepoint [3] 294131 0
during follow-up period (indefinite)
Secondary outcome [4] 294132 0
change in proteinuria as assessed by serial (3 monthly)urine samples analysed for protein to creatinine ratios.
Timepoint [4] 294132 0
12 months
Secondary outcome [5] 294133 0
change in donor specific antibody mean fluorescence index
Timepoint [5] 294133 0
12 months
Secondary outcome [6] 432091 0
Change in intragraft gene expression assessed using the Nanostring B-HOT panel. This used residual kidney biopsy tissue to assess mRNA expression using the Nanostring platform.
Timepoint [6] 432091 0
Secondary outcome [7] 432092 0
Change in intragraft gene expression assessed using the Nanostring B-HOT panel. This used residual kidney biopsy tissue to assess mRNA expression using the Nanostring platform.
Timepoint [7] 432092 0
sampled at enrolment, 3, 6 and 12 months

Eligibility
Key inclusion criteria
Renal transplant recipient
>6 months post-transplant

Biopsy evidence of cAMR defined by
- Activity - Peritubular capillaritis >10% and/or glomerulitis (g1 or greater)
- Chronic Changes - Transplant glomerulopathy or IFTA or peritubular capillary basement membrane multi-lamellation or fibrous intimal thickening of arteries.

Evidence of antibody activity
- DSAb and/or
- Positive C4d staining
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Damage to extensive
- IFTA >50%
- eGFR <25ml/min
- proteinuria >3gm/day
Too aggressive
- Banff PTC score =3
- Vascular rejection
- CMR
Concomitant biopsy findings
- Recurrent or de novo GN
- Diabetic nephropathy
- Interstitial nephritis
- BKVAN

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/03/2012
Actual
21/09/2012
Date of last participant enrolment
Anticipated
29/07/2022
Actual
21/10/2019
Date of last data collection
Anticipated
Actual
15/12/2022
Sample size
Target
50
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
Recruitment hospital [1] 11466 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 11467 0
Westmead Hospital - Westmead
Recruitment hospital [3] 11468 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [4] 11469 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [5] 11470 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [6] 11471 0
Box Hill Hospital - Box Hill
Recruitment hospital [7] 11472 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 23486 0
3168 - Clayton
Recruitment postcode(s) [2] 23487 0
2145 - Westmead
Recruitment postcode(s) [3] 23488 0
6009 - Nedlands
Recruitment postcode(s) [4] 23489 0
2050 - Camperdown
Recruitment postcode(s) [5] 23490 0
3065 - Fitzroy
Recruitment postcode(s) [6] 23491 0
3128 - Box Hill
Recruitment postcode(s) [7] 23492 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 269883 0
Government body
Name [1] 269883 0
National Blood Authority
Country [1] 269883 0
Australia
Primary sponsor type
Individual
Name
Dr William Mulley
Address
Department of Nephrology
Monash Medical Centre
246 Clayton Rd
Clayton
Vic 3168
Country
Australia
Secondary sponsor category [1] 268899 0
None
Name [1] 268899 0
Address [1] 268899 0
Country [1] 268899 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286769 0
Southern Health Human Research Ethics Committee B
Ethics committee address [1] 286769 0
Research Directorate
Southern Health
Monash Medical Centre
Locked Bag 29
Clayton South
Vic 3169
Ethics committee country [1] 286769 0
Australia
Date submitted for ethics approval [1] 286769 0
Approval date [1] 286769 0
22/02/2012
Ethics approval number [1] 286769 0
12036B

Summary
Brief summary
This trial seeks to determine if one of 2 currently used treatment regimens for chronic antibody mediated rejection of the renal allograft is superior to the other in terms of preventing chronic damage. The 2 arms include conversion to tacrolimus, mycophenolate and oral prednisolone with pulse methylprednisolone. Arm one has the addition of 3x monthly doses of IVIg. A second round of therapy will be offered if at 3 months a renal biopsy shows ongoing rejection.
Chronic damage will be assessed by chronic allograft damage index scores at 12 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33173 0
Dr William Mulley
Address 33173 0
Department of Nephrology
Monash Health
246 Clayton Rd
Clayton 3168
Victoria
Country 33173 0
Australia
Phone 33173 0
61 3 9594 3518
Fax 33173 0
Email 33173 0
[email protected]
Contact person for public queries
Name 16420 0
William Mulley
Address 16420 0
Department of Nephrology
Monash Medical Centre
246 Clayton Rd
Clayton
Vic 3168
Country 16420 0
Australia
Phone 16420 0
61 3 9594 3518
Fax 16420 0
Email 16420 0
[email protected]
Contact person for scientific queries
Name 7348 0
William Mulley
Address 7348 0
Department of Nephrology
Monash Medical Centre
246 Clayton Rd
Clayton
Vic 3168
Country 7348 0
Australia
Phone 7348 0
61 3 9594 3518
Fax 7348 0
Email 7348 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.