Condition category
Surgery
Date applied
03/11/2008
Date assigned
20/11/2008
Last edited
16/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Edit Szederkényi

ORCID ID

Contact details

Pécsi u. 6
Szeged
H-6720
Hungary

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

http://www.u-szeged.hu/indexe.html

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

Publication citations

Additional files

Editorial Notes

16/03/2016: Plain English summary added.