We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000252819
Ethics application status
Approved
Date submitted
23/02/2012
Date registered
29/02/2012
Date last updated
7/09/2020
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

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
Gender
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Address [1] 269883 0
The Commonwealth of Australia as represented by the National Blood Authority (ABN 87 361 602 478), Level 2, 243 Northbourne Avenue, Lyneham ACT 2602
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
bill.mulley@monashhealth.org
Contact person for public queries
Name 16420 0
Dr 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
bill.mulley@monashhealth.org
Contact person for scientific queries
Name 7348 0
Dr 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
bill.mulley@monashhealth.org

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 other documents available
Summary results
No Results