Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates

NCT00986947 | Terminated Phase 2 Results

• 1 other identifier: NA_00027111
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Failure

Outcome Measures

Primary Outcomes (1)

• Time to Kidney Transplantation

  4 months

Secondary Outcomes (1)

• Decrease in Panel Reactive Antibody

  4 months

Study Arms (1)

IvIg with Rituximab

EXPERIMENTAL

Drug: IVIg and rituximab

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).

Also known as: Gamunex and Rituxan

IvIg with Rituximab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Immunoglobulins, Intravenous; Rituximab

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal

Results Point of Contact

• Title: Andrew Singer, MD
• Organization: Johns Hopkins University School of Medicine

registerclinicaltrials@jhmi.edu

410-550-6484

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: September 30, 2009
• Study Start: September 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: June 1, 2017
• Results First Posted: June 1, 2017

Record last verified: 2017-05

Locations

US (1)