Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000420044
Ethics application status
Approved
Date submitted
10/05/2010
Date registered
26/05/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of B-cell depletion on clinical outcomes and histopathology of renal transplantation
Scientific title
The effect of B-cell depletion versus no induction therapy on clinical outcomes and histopathology in renal transplant recipients
Secondary ID [1] 1070 0
CRG120700129(Cochrane Renal Group)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
renal transplantation 243785 0
Condition category
Condition code
Renal and Urogenital 257399 257399 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
B cell depletion by intravenous infusion of 500mg of rituximab in saline over one hour once only before reperfusion.
The intervention group also receives immunosuppressive therapy including tacrolimus, mycophenolate mofetil and corticosteroids.
Intervention code [1] 256380 0
Prevention
Intervention code [2] 256477 0
Treatment: Other
Intervention code [3] 256517 0
Treatment: Drugs
Comparator / control treatment
control arm receives exactly the same immunosuppressive regimen (tacrolimu+mycophenolate mofetil+steroids) except no B cell depletion
Control group
Active

Outcomes
Primary outcome [1] 240854 0
Renal function estimated by Walser's equation (Am J Transplant 2004; 4: 1826-1835)
Timepoint [1] 240854 0
Monthly from baseline until 2 years
Primary outcome [2] 258477 0
Renal pathology assessed according to the BANFF criteria
Timepoint [2] 258477 0
before reperfusion and 24 months after transplantation
Primary outcome [3] 258478 0
Human Lymphocyte antigen (HLA) antibody assessed by flow panel reactive antibodies
Timepoint [3] 258478 0
before Transplantation and every 6 months until 2 years after transplantation
Secondary outcome [1] 257524 0
Incidence of acute rejection assessed by analysis of serum creatinine and renal biopsy confirmation as data linkage to medical records
Timepoint [1] 257524 0
12 months and 24 months post transplantation
Secondary outcome [2] 264211 0
graft failure defined by dialysis therapy for more than 2 weeks or creatinine levels higher than 10 mg/dl and checked by regular outpatient and telephone follow-up
Timepoint [2] 264211 0
monthly until 24 months post transplantation
Secondary outcome [3] 264212 0
patient death checked by regular outpatient and telephone follow-up
Timepoint [3] 264212 0
monthly until 24 months post transplantation

Eligibility
Key inclusion criteria
Male or female patients at 15-65 years of age undergoing renal transplantation
Patients who have been informed of the potential risks and side effects of the study
Patients who have given written informed consent to participate in the study
Minimum age
15 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Donor age greater than 65 years
Patients receiving a perfectly matched kidney (6 matches HLA A, B, DR)
Patients who are recipients of multiple solid organ transplants
Patients undergoing second or subsequent transplantation

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 2108 0
Taiwan, Province Of China
State/province [1] 2108 0

Funding & Sponsors
Funding source category [1] 243686 0
Charities/Societies/Foundations
Name [1] 243686 0
Digestive Organ Transplantation Foundation
Country [1] 243686 0
Taiwan, Province Of China
Primary sponsor type
Charities/Societies/Foundations
Name
Digestive Organ Transplantation Foundation
Address
7, Chung-shan South Rd, Taipei 100, Taiwan
Country
Taiwan, Province Of China
Secondary sponsor category [1] 256159 0
Government body
Name [1] 256159 0
National Science Council, Taiwan
Address [1] 256159 0
7, Chung-shan South Rd, Taipei 100, Taiwan
Country [1] 256159 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 30239 0
Address 30239 0
Country 30239 0
Phone 30239 0
Fax 30239 0
Email 30239 0
Contact person for public queries
Name 13486 0
Dr, Meng-Kun, Tsai
Address 13486 0
Assistant Professor, Department of Surgery, National Taiwan University Hospital, 7, Chung-Shan South Rd, Taipei 100, Taiwan
Country 13486 0
Taiwan, Province Of China
Phone 13486 0
+886 2 23123456-65622
Fax 13486 0
Email 13486 0
mengkuntsai@ntu.edu.tw
Contact person for scientific queries
Name 4414 0
Ms, Ming-Hui, Lin
Address 4414 0
Study Coordinator, Department of Surgery, National Taiwan University Hospital, 7, Chung-Shan South Rd, Taipeim 100, Taiwan
Country 4414 0
Taiwan, Province Of China
Phone 4414 0
+886 2 23123456-65622
Fax 4414 0
Email 4414 0
octn@ntuh.gov.tw

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo inconclusive

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA systematic review of the use of rituximab as induction therapy in renal transplantation.2015https://dx.doi.org/10.1016/j.trre.2014.12.001
N.B. These documents automatically identified may not have been verified by the study sponsor.