Induction therapy in transplantation

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN17364752
• Date of registration: 25/04/2016
• Prospective Registration: No
• Primary sponsor: Shahid Beheshti Medical University
• Public title: Induction therapy in transplantation
• Scientific title: The appropriate dose of thymoglobulin induction therapy in kidney transplantation
• Date of first enrolment: 10/01/2013
• Target sample size: 90
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN17364752
• Study type: Interventional
• Study design: Single-centre open-label tree-arm randomized parallel trial (Treatment)
• Phase: Phase I/II

Countries of recruitment

Iran

Contacts

• Name: Behrang Alipour

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Acute transplant rejection
Signs and Symptoms
Acute transplant rejection

Intervention(s)

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.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

N/A

Source(s) of Monetary Support

Labbafinejad Hospital