ANZCTR - Registration

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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]

CRG120700129(Cochrane Renal Group)

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

renal transplantation

Condition category

Condition code

Renal and Urogenital

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]

Prevention

Intervention code [2]

Treatment: Other

Intervention code [3]

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]

Renal function estimated by Walser's equation (Am J Transplant 2004; 4: 1826-1835)

Timepoint [1]

Monthly from baseline until 2 years

Primary outcome [2]

Renal pathology assessed according to the BANFF criteria

Timepoint [2]

before reperfusion and 24 months after transplantation

Primary outcome [3]

Human Lymphocyte antigen (HLA) antibody assessed by flow panel reactive antibodies

Timepoint [3]

before Transplantation and every 6 months until 2 years after transplantation

Secondary outcome [1]

Incidence of acute rejection assessed by analysis of serum creatinine and renal biopsy confirmation as data linkage to medical records

Timepoint [1]

12 months and 24 months post transplantation

Secondary outcome [2]

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]

monthly until 24 months post transplantation

Secondary outcome [3]

patient death checked by regular outpatient and telephone follow-up

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Taiwan, Province Of China

State/province [1]

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Digestive Organ Transplantation Foundation

Address [1]

7, Chung-shan South Rd, Taipei 100, Taiwan

Country [1]

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]

Government body

Name [1]

National Science Council, Taiwan

Address [1]

7, Chung-shan South Rd, Taipei 100, Taiwan

Country [1]

Taiwan, Province Of China

Ethics approval

Ethics application status

Approved

Summary

Brief summary

Can B cell depletion during the early phase of renal transplantation reduce HLA antibody production and lessen chronic allograft rejection?

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr, Meng-Kun, Tsai

Address

Assistant Professor, Department of Surgery, National Taiwan University Hospital, 7, Chung-Shan South Rd, Taipei 100, Taiwan

Country

Taiwan, Province Of China

Phone

+886 2 23123456-65622

Fax

[email protected]

Contact person for scientific queries

Name

Ms, Ming-Hui, Lin

Address

Study Coordinator, Department of Surgery, National Taiwan University Hospital, 7, Chung-Shan South Rd, Taipeim 100, Taiwan

Country

Taiwan, Province Of China

Phone

+886 2 23123456-65622

Fax

[email protected]

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		inconclusive

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A systematic review of the use of rituximab as induction therapy in renal transplantation.	2015	https://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.

Trial Review

Documents added manually

Documents added automatically