Plain English Summary
Background and study aims
In a healthy person, the kidneys are responsible for filtering out the waste products and excess water in the blood, and converting them into urine. If the kidneys suddenly stop working (acute kidney injury) or are suffering from severe, long-term disease of the kidneys (chronic kidney failure) then the body is unable to get rid of the waste products building up in the blood. Eventually, the kidneys are no longer able to support the body’s needs (end stage renal disease) and so a treatment which replaces the work of the failed kidney is needed. Kidney transplantation is the best treatment for end-stage renal disease, however there is a risk that the new kidney (graft) will fail. Chronic allograft nephropathy is the biggest cause of graft failure in kidney transplant patients. Losartan is a type of medication called an angiotensin II receptor blocker (ARB), which is mainly used to treat high blood pressure. Lab-based studies have shown that it can decrease the production of chemicals in the body called TGF β and miR 21, which are major causes of chronic allograft nephropathy, by blocking the genes that code for them. The aim of this study is to find out whether losartan can reduce fibrosis and improve graft function in kidney transplant patients.
Who can participate?
Adults who have had their first kidney transplant from an unrelated, living donor.
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group receive take tablets containing 25mg losartan every day for six months after their transplant. Participants in the second group receive no losartan, but can be treated with medication to lower blood pressure (except ACE inhibitors or other angiotensin II receptor blockers). After six months, participants have a sample of blood taken to measure how effectively the new kidney is working.
What are the possible benefits and risks of participating?
Participants who take the losartan may benefit from a lower chance of loss of function of their new kidney. There is a small risk of developing hyperkalemia (high potassium) when taking losartan, however patients will be closely monitored to avoid this. There is a risk of bleeding, discomfort or bruising during and after blood samples are taken.
Where is the study run from?
Labbafinejad Hospital (Iran)
When is the study starting and how long is it expected to run for?
September 2013 to November 2015
Who is funding the study?
Shahid Beheshti Medical University (Iran)
Who is the main contact?
Dr Behrang Alipour
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effect of the renin-angiotensin system inhibitors after renal transplantation on chronic allograft nephropathy through down regulation of TGF β and miR 21 in kidney transplant patients Labbafinejad center of Tehran
Acronym
Study hypothesis
Losartan is effective at reducing fibrosis and TGF-β, and slowing the decline of kidney function in kidney transplant patients.
Ethics approval
Urology Nephrology Research Center, Shahid Behehsti Medical University (UNRC-SMBU)
Study design
Single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No specific participant information sheet available, please use the contact details below to request a further information.
Condition
Allograft nephritis
Intervention
Participants are randomly allocated to one of two groups.
Intervention group: Participants receive 25mg oral losartan daily for six months post transplantation.
Control group: Participants receive nothing or other antihypertensive drug except ACEi, ARB.
Participants in both groups are followed up at 6 months.
Intervention type
Drug
Phase
Phase I/II
Drug names
Losartan
Primary outcome measure
1. Graft function is determined by measuring eGFR at 48 hours, 3 and 6 months post transplantation
2. Fibrosis is measured by measuring TGF-β and miR 21 levels using real time PCR at 48 hours, 3 and 6 months post transplantation
Secondary outcome measures
No secondary outcome measures.
Overall trial start date
10/09/2013
Overall trial end date
19/11/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. First kidney transplantation of living unrelated donor
2. Compliance to losartan
3. No allergic reaction to losartan
4. Agreement to participate in the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Second transplant
2. Cadaveric transplant
3. Acute rejection during first week after transplantation
4. Delayed graft function during first week after transplantation
Recruitment start date
19/11/2013
Recruitment end date
21/12/2013
Locations
Countries of recruitment
Iran
Trial participating centre
Labbafinejad Hospital
Boostan 9th Street
Pasdaran Avenue
Tehran
1213226544
Iran
Funders
Funder type
University/education
Funder name
Shahid Beheshti Medical University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in the Iranian Journal of Kidney Diseases.
Intention to publish date
19/11/2016
Participant level data
Not expected to be available
Basic results (scientific)
Publication list