Kidney allograft protocol biopsy program

ISRCTN	ISRCTN42131433
DOI	https://doi.org/10.1186/ISRCTN42131433
Secondary identifying numbers	HU-SZTE-2205

Submission date: 03/11/2008
Registration date: 20/11/2008
Last edited: 16/03/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
A biopsy is a procedure that involves taking a small sample of body tissue. It can be used to assess the functioning of a transplanted kidney (graft). A protocol biopsy is a biopsy taken at set intervals after transplantation. The aim of this study is to find out whether treating patients based on protocol biopsy findings improves the functioning and long-term survival of the transplanted kidney.

Who can participate?
Patients aged 18 or over who have received a kidney transplant

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in one group undergo a protocol biopsy 3 and/or 12 months after kidney transplantation, and based on the results receive appropriate treatment (e.g., steroids, drug dose reduction or withdrawal, antibiotics). Participants in the other group do not undergo a protocol biopsy and are treated based on clinical symptoms (if any occur). Kidney function and graft survival are assessed at 3 months after transplantation, then monthly until 12 months, then every 3 months until 10 years or graft loss.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University of Szeged (Hungary)

When is the study starting and how long is it expected to run for?
November 2002 to December 2016

Who is funding the study?
University of Szeged (Hungary)

Who is the main contact?
Dr Edit Szederkényi

Contact information

Dr Edit Szederkényi
Scientific

Pécsi u. 6
Szeged
H-6720
Hungary

Study information

Study design	Open randomised controlled single-centre clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Role of protocol biopsy in preserving kidney allograft function: an open, randomised, controlled, single centre clinical trial
Study acronym	ProBiRAF
Study objectives	Treatment of patients based on the protocol biopsy findings promotes preservation of the kidney allograft function, and therefore improves the long-term graft survival.
Ethics approval(s)	Human Investigation Review Board of the University of Szeged, Albert Szent-Györgyi Clinical Centre, 19/03/2002, ref: 2205
Health condition(s) or problem(s) studied	Long-term graft survival
Intervention	Intervention: ultrasound-guided protocol biopsy 3 and/or 12 months after kidney transplantation. Based on the histology, appropriate treatment: 1. Steroid intravenous (i.v.) bolus 2. CNI dose reduction or withdrawal 3. Antibiotics Control group: no protocol biopsy; treated based on clinical symptoms (if any occur). 10 years follow-up is planned, analysing data annually.
Intervention type	Procedure/Surgery
Primary outcome measure	1. Renal function measured by the serum creatinine and the estimated glomerular filtration rate (GFR) 2. Graft survival 3. Renal lesions measured by the Banff score Time points: Baseline, 3 months after transplantation, then monthly until 12 months, then every 3 months until 10 years or graft loss.
Secondary outcome measures	1. Proteinuria 2. Serum glucose 3. Total cholesterol 4. High density lipoprotein (HDL) cholesterol 5. Low density lipoprotein (LDL) cholesterol 6. Triglyceride 7. Blood pressure 8. Cardiovascular events (number of events) Time points: Baseline, 3 months after transplantation, then monthly until 12 months, then every 3 months until 10 years or graft loss.
Overall study start date	15/11/2002
Completion date	31/12/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	30 patients per year (150 in total)
Key inclusion criteria	1. Adult patients (aged greater than 18 years), either sex 2. Receiving kidney transplant 3. A stable graft function (serum creatinine less than 300 µmol/l) three months after transplantation 4. No clinical symptoms or rejection for two months 5. Taking calcineurin-inhibitor (CNI) and mycophenolate mofetil (MMF) combination immunosuppressive therapy 6. A stable immunosuppressive drug trough level (tacrolimus [Tac] 5 - 15 ng/ml, cyclosporin [CsA] 100 - 250 ng/ml) 7. Signed informed consent, good compliance
Key exclusion criteria	1. Rejection episode in the last two months 2. Taking anticoagulation therapy 3. Active infection
Date of first enrolment	15/11/2002
Date of final enrolment	31/12/2016

Locations

Countries of recruitment

Hungary

Study participating centre

Pécsi u. 6.

Szeged
H-6720
Hungary

Sponsor information

University of Szeged (Hungary)
University/education

Albert Szent-Györgyi Clinical Centre
Department of Clinical Surgery
Pécsi u. 6.
Szeged
H-6720
Hungary

Phone	+36 (0)662 545 702
Email	se@surg.szote.u-szeged.hu
Website	http://www.u-szeged.hu/indexe.html
"ROR"	https://ror.org/01pnej532

Funders

Funder type

University/education

University of Szeged (Hungary) - Albert Szent-Györgyi Clinical Centre, Department of Clinical Surgery

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

16/03/2016: Plain English summary added.