AMC-DRIP
- Conditions
- Highly sensitized renal transplant recipients, desensitization, high PRA, kidney transplantation.Hoog gesensibiliseerde niertransplantatie patienten, desensibilisatie, hoge PRA, niertransplantatie
- Registration Number
- NL-OMON26482
- Lead Sponsor
- Dr. Ajda T. Rowshani; Nephrologist-Clinical ImmunologistAcademic Medical CenterDepartment of Internal Medicine, F4-215PO Box 22700100 DE Amsterdam, The NetherlandsTel: +31-20-5663365 page 58816Fax: +31-20-6914904E-mail:T.Rowshani@AMC.UVA.
- Brief Summary
ot applicable.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 17
Inclusion Criteria
Patients older than 18 years with end stage renal failure and a current PRA higher than 80 % who are for more than two years on the waiting list for a cadaveric donor kidney, and included in the AM program. Only heart beating donors will be accepted.
Exclusion Criteria
A. Complete IgA deficiency
B. Overhydration
C. History of anaphylaxis against blood/plasma products
D. Significant cardiac or pulmonary disease, hepatitis C or HIV infection, or malignancy
within the last 5 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point is achievement of a negative cross-match test with the donor kidney and transplantability.
- Secondary Outcome Measures
Name Time Method Secondary objectives are <br>1. Patient and graft survival;<br>2. Graft function as assessed by calculated creatinine clearance, proteinuria, the number and severity of acute (antibody mediated) rejections, blood pressure (antihypertensive treatment), monitoring of infections and the occurrence of malignancies.