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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00371904




Registration number
NCT00371904
Ethics application status
Date submitted
1/09/2006
Date registered
4/09/2006
Date last updated
21/05/2008

Titles & IDs
Public title
Trial of Rituximab Given Pre-Transplant to Sensitised Live Donor Kidney Recipients
Scientific title
A Prospective Open Label Randomised Multicentre Study Evaluating the Efficacy & Safety of Rituximab Given Pre-Transplant to Sensitised Renal Allograft Recipients in Addition to a "Standard" Desensitisation Regimen Consisting of PE/IVIG & MMF
Secondary ID [1] 0 0
RAPTURE
Universal Trial Number (UTN)
Trial acronym
RAPTURE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Transplantation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rituximab
Treatment: Drugs - Standard Care

Experimental: 1 -

Active comparator: 2 -


Treatment: Drugs: Rituximab
Single dose (375 mg/m2) of rituximab to be given intravenously (IV) 14 days prior to transplantation

Treatment: Drugs: Standard Care
Standard care
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Biopsy proven antibody mediated rejection
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Elimination of donor specific antibodies (DSA)
Timepoint [1] 0 0
Day - 2 , 7; Months 1, 3, 6, 9 and 12
Secondary outcome [2] 0 0
C4d in biopsies
Timepoint [2] 0 0
Day 7; Months 3 and 12
Secondary outcome [3] 0 0
Plasma exchanges
Timepoint [3] 0 0
Month 12
Secondary outcome [4] 0 0
Death
Timepoint [4] 0 0
Month 12
Secondary outcome [5] 0 0
Treated rejection
Timepoint [5] 0 0
Month 12
Secondary outcome [6] 0 0
Graft loss
Timepoint [6] 0 0
Months 3, 6 and 12
Secondary outcome [7] 0 0
Treatment failure
Timepoint [7] 0 0
Months 6 and 12
Secondary outcome [8] 0 0
Calculation of glomerular filtration rate (GFR)
Timepoint [8] 0 0
Months 1 - 12
Secondary outcome [9] 0 0
Slope of 1/serum creatinine (Ser. Cr)
Timepoint [9] 0 0
Months 6 and 12
Secondary outcome [10] 0 0
24-hour U protein
Timepoint [10] 0 0
Months 3 and 12
Secondary outcome [11] 0 0
Safety
Timepoint [11] 0 0
Month 12
Secondary outcome [12] 0 0
Cancer and infections
Timepoint [12] 0 0
Month 12

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Subjects, age > 18 years
2. Subjects receiving a single organ renal transplant from a living donor
3. Positive T-cell and/or B-cell crossmatch by complement dependent cytotoxicity (CDC) and/or positive flow cytometry crossmatch with confirmed donor-specific antibodies on solid-phase assay at screening. Positive CDC T-cell and/or B-cell crossmatch titre must be less than or equal to 1:64.
4. Subjects capable of understanding the purposes and risks of the study and who can give written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria at Study Entry (4 weeks prior to transplant):

1. Primary renal transplant lost from acute rejection less than six months prior to randomisation
2. Women of childbearing potential with a positive serum or urine pregnancy test or nursing mothers
3. Subjects with history of malignancy (other than non melanoma skin cancer that has been totally excised with no recurrence for two years)
4. Subjects with known contraindications to treatment with rituximab
5. Subjects with haemoglobin < 8.5 g/dL, WBC value of < 3000/mm3 or a platelet count of < 50,000/mm3 that is unlikely to resolve prior to randomisation
6. Subjects with a positive ABO crossmatch with donor
7. Subjects with severe diarrhoea or other gastrointestinal disorders that might interfere with the ability to absorb oral medication and is unlikely to resolve prior to randomisation
8. Subjects participating in another interventional clinical trial or requiring treatment with un-marketed investigational drugs or who would be expected to require other medications prohibited by the protocol
9. Subjects who cannot be followed for the study duration
10. Subjects with disorders or conditions that may interfere with the ability to comply with study procedures and/or requirements

Additional Exclusion Criteria at Day -2 before Transplantation:

1. All exclusion criteria as at study entry
2. Positive T- and/or B-cell CDC crossmatch at Day -2

Study design
Purpose of the study
Prevention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2009
Actual
Sample size
Target
192
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Newcastle Transplant Unit, John Hunter Hospital - Newcastle
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2305 - Newcastle
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Hunter and New England Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Melbourne Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Princess Alexandra Hospital, Brisbane, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Royal Prince Alfred Hospital, Sydney, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
Auckland City Hospital
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Monash Medical Centre
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Royal Perth Hospital
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Westmead Hospital
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Royal Adelaide Hospital
Address [8] 0 0
Country [8] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
About one third of prospective kidney transplant recipients have antibodies in their blood directed against the tissues of their only available kidney donor. Recently, "desensitisation" treatments when administered pre-transplant have allowed successful transplantation of these patients despite high rates of acute antibody mediated rejection (AAMR). The investigators propose to test in a randomised controlled trial whether rituximab, a monoclonal antibody that depletes B-lymphocytes, will safely lower antibody mediated rejection (AMR) rates when added to "standard" therapy. The investigators will also test whether rituximab enables more patients to achieve a negative crossmatch against their donor and thereby allow more transplants to proceed.
Trial website
https://clinicaltrials.gov/study/NCT00371904
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul R Trevillian, MBBS, FRACP
Address 0 0
Newcastle Transplant Unit, John Hunter Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Paul R Trevillian, MBBS, FRACP
Address 0 0
Country 0 0
Phone 0 0
+61414417311
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00371904