Condition category
Urological and Genital Diseases
Date applied
29/02/2016
Date assigned
25/06/2016
Last edited
23/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Public

Primary contact

Dr Behrang Alipour

ORCID ID

Contact details

Chronic Kidney Disease Research Center (CKDRC)
Shahid Beheshti Medical University
9th Boostan Street
Pasdaran Avenue
Tehran
1265326541
Iran

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 measures

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

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

Sponsor information

Organisation

Shahid Beheshti Medical University

Sponsor details

Chronic Kidney Disease Research Center (CKDRC)
9th Boostan Street
Pasdaran Avenue
Tehran
1256545623
Iran

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes