Condition category
Signs and Symptoms
Date applied
29/02/2016
Date assigned
25/04/2016
Last edited
18/04/2016
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 to replace the work of the failed kidneys is needed. Kidney transplantation is the best treatment for end-stage renal disease. One of the biggest risks after a patient has had a kidney transplant is that the immune system (the body’s natural defense) attacks the new kidney as it recognizes it as foreign tissue (acute transplant rejection). The main way of preventing this from happening is by treating patients with drugs that suppress the activity of the immune system to ensure the transplant survives (induction therapy). Thymoglobin is a medication commonly used to help prevent and treat rejection in kidney transplant patients. It can be very effective however the best possible dose to use is not yet known. The aim of this study is to compare three different doses of thymoglobin in order to find the most safe and effective dose.

Who can participate?
Adult kidney transplant recipients.

What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group receive a total of 4.5 mg/kg thymoglobulin over three days, which involves receiving 1.5 mg/kg each day through a drip for six hours. Those in the second group receive a total of 4.5 mg/kg thymoglobulin, which is all given through a drip over six hours on one day. Those in the third group receive a total of 6 mg/kg thymoglobulin over three days, which involves receiving 2 mg/kg each day through a drip for six hours. Participants in all groups are followed up six months and one year after their transplant in order to find out the amount who have suffered from transplant rejection and serious infections.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with taking part in this study.

Where is the study run from?
Labbafinejad Hospital (Iran)

When is the study starting and how long is it expected to run for?
November 2012 to April 2015

Who is funding the study?
Labbafinejad Hospital (Iran)

Who is the main contact?
Dr Behrang Alipour

Trial website

Contact information

Type

Scientific

Primary contact

Dr Behrang Alipour

ORCID ID

Contact details

Shahid Beheshti Medical University
Chronic Kidney Disease Research Center (CKDRC)
9th Boostan Street
Pasdaran Avenue
Tehran
1256958585
Iran

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The appropriate dose of thymoglobulin induction therapy in kidney transplantation

Acronym

Study hypothesis

Giving thymoglobulin in a 4.5 mg /kg in 3 days protocol is safe with lower infectious complications in comparison with higher doses or bolus protocols.

Ethics approval

Urology Nephrology Research Center, Shahid Beheshti Medical University (UNRC-SBMU), 01/01/2013

Study design

Single-centre open-label tree-arm randomized parallel trial

Primary study design

Interventional

Secondary study design

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

Acute transplant rejection

Intervention

Participants are randomly allocated to one of three groups.

Group 1: Participants are treated with a total of 4.5 mg/kg in 3 days, receiving 1.5 mg/kg in each days infused over 6 hours
Group 2: Participants are treated with a total of 4.5 mg/kg single bolus dose), infused over 6 hours in one day
Group 3: Participants are treated with total dose 6 mg/kg in 3 days, receiving 2 mg/kg in each day infused over 6 hours

The first dose of thymoglobulin is given over six hours beginning intra-operatively (peri perfusion of the allograft). Subsequent doses are given over at least four hours and withheld if the platelet count drops below 50,000 per mm3 or the white blood cell (WBC) count drops below 2,000 per mm3. An initial WBC of >2000/ mm2 and PLT of > 75000/mm2 is required to start treatment. If the platelet count is between 50,000–75,000 per mm3 or the WBC count is between 2,000–3,000 per mm3 the thymoglobulin dose is halved.

Intervention type

Drug

Phase

Phase I/II

Drug names

Thymoglobulin

Primary outcome measures

Rate and severity of acute rejection during the first year post-transplantation is measured using kidney biopsy at 6 months post-transplantation.

Secondary outcome measures

1. Time to and the rate of serious infections are measured using history of admissions and blood culture and urine culture taken at each time admission for one year after transplantation
2. CMV infection rate is measured using CMV Ag pp65 antigenemia confirmed by CMV PCR monthly for one year after transpmantation
3. Length of hospital stay is measured through patient note review for any hospital admission within one year of transplantation
4. Rate of readmission is measured through patient note review for one year after transplantation
5. Incidence of hematologic abnormalities and renal function are assessed by measuring serum creatinine and estimating glomerular filtration rate using CKD-EPI using CKD-EPI and checking CBC (diff) monthly at each visit for one year after transplantation

Overall trial start date

20/11/2012

Overall trial end date

15/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 18 and 65 years
2. Positive Panel Reactive Antibody (PRA) (> 0%) at the time of transplantation
3. History of previous transplantation
4. Extended criteria donor (ECD)
5. Cold ischemia time > 6 hours

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. Multiple organ transplants
2. Serological evidence of human immunodeficiency virus or active hepatitis B and C in recipients or donors

Recruitment start date

10/01/2013

Recruitment end date

21/02/2013

Locations

Countries of recruitment

Iran

Trial participating centre

Labbafinejad Hospital
9th Boostan Street Pasdaran Avenue
Tehran
1256365485
Iran

Sponsor information

Organisation

Shahid Beheshti Medical University

Sponsor details

Chronic Kidney Disease Research Center (CKDRC)
9th Boostan Street
Pasdaran Avenue
Tehran
2152565458
Iran

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Labbafinejad Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in an ISI journal.

Intention to publish date

31/12/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes