Intravenous Immune Globulin (IVIG) Treatment Protocol in Kidney Transplant Patients

NCT00586716 | Terminated Results

• 1 other identifier: 54298
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Elimination of Donor Specific Antibodies

  1 year

Secondary Outcomes (1)

• Negative B and T Cell Crossmatch

  1year

Study Arms (2)

Group 1 intravenous immune globulin

OTHER

Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list

Drug: intravenous immune globulin

Group 2 intravenous immune globulin

OTHER

Intravenous immune globulin for patients who have living donors with positive crossmatch results.

Drug: intravenous immune globulin

Interventions

intravenous immune globulin DRUG

0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments

Group 1 intravenous immune globulin; Group 2 intravenous immune globulin

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• diagnosed with end stage renal disease
• currently receiving either hemodialysis or peritoneal dialysis
• active on the kidney or kidney/pancreas transplant list
• medical clearance of the kidney donor if live related transplant
• elevated panel reactive antibody (PRA) greater that 30% for 3 consecutive monthly tests and one positive crossmatch with a cadaveric donor while on the transplant waiting list

You may not qualify if:

• received IVIG within 6 months prior to enrollment
• HIV positive
• Positive Hepatitis Be-antigen and/or hepatitis B viral DNA
• Selective IgA deficiency or known antibodies to IgA
• Allergy to human immune globulin
• Pregnant or breast feeding

Sponsors & Collaborators

• Loma Linda University: lead

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

A limitation to this study is early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. Pedro Baron
• Organization: Loma Linda University Medical Center

PBaron@llu.edu

909-558-6792

Study Officials

• Okechukwu Ojogho, MD

  Loma Linda Universtiy Adventist Health Sciences Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 4, 2008
• Study Start: November 1, 2004
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2009
• Last Updated: January 9, 2017
• Results First Posted: June 6, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share