Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT00986947
Phase
PHASE2
Status
Terminated

Conditions

  • Kidney Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • IVIg and rituximab — DRUG
    A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses. If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA).

Study Details

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.

Key Dates

Start date
Sep 30, 2009
Status verified
May 2017
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: IvIg with Rituximab

Primary Outcome Measure

Time to Kidney Transplantation [ Time Frame: 4 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Medical InstitutionsBaltimoreMaryland21205-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins Medical Institutions· Baltimore, MD

Related Studies