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Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates

Johns Hopkins University logo

Johns Hopkins University

Status and phase

Terminated
Phase 2

Conditions

Kidney Failure

Treatments

Drug: IVIg and rituximab

Study type

Interventional

Funder types

Other

Identifiers

NCT00986947
NA_00027111

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

IvIg with Rituximab
Experimental group
Treatment:
Drug: IVIg and rituximab

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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