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 designOpen randomised controlled single-centre clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRole of protocol biopsy in preserving kidney allograft function: an open, randomised, controlled, single centre clinical trial
Study acronymProBiRAF
Study objectivesTreatment 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) studiedLong-term graft survival
InterventionIntervention: 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 typeProcedure/Surgery
Primary outcome measure1. 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 measures1. 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 date15/11/2002
Completion date31/12/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants30 patients per year (150 in total)
Key inclusion criteria1. 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 criteria1. Rejection episode in the last two months
2. Taking anticoagulation therapy
3. Active infection
Date of first enrolment15/11/2002
Date of final enrolment31/12/2016

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

16/03/2016: Plain English summary added.