Desensitization of highly pre-sensitized dialysis patients waiting for kidney transplantation by Rituximab, IVIG-L and rescue Plasmapheresis THE DRIP STUDY

Phase 3

• Conditions: niertransplantatie; Transplantation

• Registration Number: NL-OMON30466
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

-Patients older than 18 years with end stage renal failure and a current Panel Reactive Antibody level >= 80 % who are for more than two years on the waiting list for a cadaveric donor kidney, and included in the Acceptable Mismatch program of Eurotransplant.
-Written informed consent

Exclusion Criteria

Complete IgA deficiency
Overhydration
History of anaphylaxis against blood/plasma products
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
<p>Primary end point is achievement of a negative cross-match test with the donor<br /><br>kidney and transplantability.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are patient and graft survival, graft function as assessed<br /><br>by calculated creatinine clearance, proteinuria, the number and severity of<br /><br>acute (antibody mediated) rejections, blood pressure (antihypertensive<br /><br>treatment), monitoring of infections and the occurrence of malignancies.</p><br>