Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates

Phase 2

Terminated

• Conditions: Kidney Failure
• Interventions: Drug: IVIg and rituximab

• Registration Number: NCT00986947
• Lead Sponsor: Johns Hopkins University

Brief Summary

Some patients who need kidney transplants have high levels of antibodies that make them incompatible with most potential deceased donor kidney offers. These patients are considered highly-sensitized and are very difficult to transplant because the likelihood that they will receive a compatible organ is very low. There are some medications and procedures that can decrease the antibody levels and this can increase the chance of finding a compatible donor for these patients. In this study the investigators will give two medications (IVIg and Rituximab) to highly-sensitized patients who are on the waiting list for a deceased donor kidney transplant. After the investigators administer these medications, the investigators will continue to check for compatibility as organ offers are received. If a compatible organ offer is received, the investigators will perform the transplant using that organ. The investigators hypothesize that these medications will lower antibody levels and increase the chance that a these patients are able to receive a compatible kidney transplant.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Results First Submitted: 2017-03-21
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-01
• Last Update Submitted: 2017-05-01
• Results First Posted: 2017-06-01
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Ages 18-75
• End-stage renal disease on dialysis
• Panel Reactive Antibody (PRA) > 60%
• Have been evaluated for and are currently listed for deceased donor renal transplantation

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Exclusion Criteria

• Have contraindication to transplantation
• Have contraindication to receiving IVIG
• Have allergy to IVIG
• Have received IVIG for desensitization previously without effect
• Pregnant women or those intending to become pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IvIg with Rituximab	IVIg and rituximab	-

Primary Outcome Measures

Name	Time	Method
Time to Kidney Transplantation	4 months

Secondary Outcome Measures

Name	Time	Method
Decrease in Panel Reactive Antibody	4 months

Trial Locations

Locations (1)

Johns Hopkins Medical Institutions; 🇺🇸 Baltimore, Maryland, United States