Effects of B-cell depletion on clinical outcomes and histopathology of renal transplantatio
Phase 4
Recruiting
- Conditions
- renal transplantationRenal and Urogenital - Kidney disease
- Registration Number
- ACTRN12610000420044
- Lead Sponsor
- Digestive Organ Transplantation Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Male or female patients at 15-65 years of age undergoing renal transplantation
Patients who have been informed of the potential risks and side effects of the study
Patients who have given written informed consent to participate in the study
Exclusion Criteria
Donor age greater than 65 years
Patients receiving a perfectly matched kidney (6 matches HLA A, B, DR)
Patients who are recipients of multiple solid organ transplants
Patients undergoing second or subsequent transplantation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Renal function estimated by Walser's equation (Am J Transplant 2004; 4: 1826-1835)[Monthly from baseline until 2 years];Renal pathology assessed according to the BANFF criteria[before reperfusion and 24 months after transplantation];Human Lymphocyte antigen (HLA) antibody assessed by flow panel reactive antibodies[before Transplantation and every 6 months until 2 years after transplantation]
- Secondary Outcome Measures
Name Time Method Incidence of acute rejection assessed by analysis of serum creatinine and renal biopsy confirmation as data linkage to medical records[12 months and 24 months post transplantation];graft failure defined by dialysis therapy for more than 2 weeks or creatinine levels higher than 10 mg/dl and checked by regular outpatient and telephone follow-up[monthly until 24 months post transplantation];patient death checked by regular outpatient and telephone follow-up[monthly until 24 months post transplantation]