Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates

Kidney Failure Clinical Trial

Official title:

Phase 2 Study of IVIg and Rituximab for Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00986947
• Other study ID #: NA_00027111
• Status: Completed
• Phase: Phase 2
• First received: September 29, 2009
• Last updated: August 17, 2011
• Start date: September 2009
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Ages 18-75

• End-stage renal disease on dialysis

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Intervention

Drug:
• IVIg and rituximab
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).

Locations

Country	Name	City	State
United States	Johns Hopkins Medical Institutions	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to kidney transplantation		4 months	No
Secondary	Decrease in panel reactive antibody		4 months	No