Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HU-SZTE-2205
Study information
Scientific title
Role of protocol biopsy in preserving kidney allograft function: an open, randomised, controlled, single centre clinical trial
Acronym
ProBiRAF
Study hypothesis
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
Human Investigation Review Board of the University of Szeged, Albert Szent-Györgyi Clinical Centre, 19/03/2002, ref: 2205
Study design
Open randomised controlled single-centre clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
15/11/2002
Overall trial end date
31/12/2016
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30 patients per year (150 in total)
Participant exclusion criteria
1. Rejection episode in the last two months
2. Taking anticoagulation therapy
3. Active infection
Recruitment start date
15/11/2002
Recruitment end date
31/12/2016
Locations
Countries of recruitment
Hungary
Trial participating centre
Pécsi u. 6.
Szeged
H-6720
Hungary
Sponsor information
Organisation
University of Szeged (Hungary)
Sponsor details
Albert Szent-Györgyi Clinical Centre
Department of Clinical Surgery
Pécsi u. 6.
Szeged
H-6720
Hungary
+36 (0)662 545 702
se@surg.szote.u-szeged.hu
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Szeged (Hungary) - Albert Szent-Györgyi Clinical Centre, Department of Clinical Surgery
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary