Induction therapy in transplantatio

Phase 1

Completed

Conditions: Acute transplant rejection
Signs and Symptoms

Registration Number: ISRCTN17364752

Lead Sponsor: Shahid Beheshti Medical University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 90

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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<br>2. CMV infection rate is measured using CMV Ag pp65 antigenemia confirmed by CMV PCR monthly for one year after transpmantation<br>3. Length of hospital stay is measured through patient note review for any hospital admission within one year of transplantation<br>4. Rate of readmission is measured through patient note review for one year after transplantation<br>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