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

Primary Purpose

End Stage Renal Disease

Status

Terminated

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

intravenous immune globulin

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

12 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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Group 1 intravenous immune globulin

Group 2 intravenous immune globulin

Arm Description

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

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

Outcomes

Primary Outcome Measures

Elimination of Donor Specific Antibodies

Secondary Outcome Measures

Negative B and T Cell Crossmatch

Full Information

NCT ID

NCT00586716

First Posted

December 21, 2007

Last Updated

November 17, 2016

Sponsor

Loma Linda University

1. Study Identification

Unique Protocol Identification Number

NCT00586716

Brief Title

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

Official Title

IVIG Treatment for Live-donor Renal Transplant Patients With a Positive Crossmatch and in Patients With High PRA

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Terminated

Why Stopped

Insufficient recruitment

Study Start Date

November 2004 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Loma Linda University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Detailed Description

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. There are two arms in the study, one in which IVIG is administered to patients who have living donors with positive crossmatch results, and another in which intravenous immune globulin is administered to patients with no living donor and have a PRA greater than 30% for 3 consecutive months and a crossmatch with a cadaveric donor while on kidney transplant waiting list. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1 intravenous immune globulin

Arm Type

Other

Arm Description

Arm Title

Group 2 intravenous immune globulin

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

intravenous immune globulin

Intervention Description

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

Primary Outcome Measure Information:

Title

Elimination of Donor Specific Antibodies

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Negative B and T Cell Crossmatch

Time Frame

1year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 12 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Okechukwu Ojogho, MD

Organizational Affiliation

Loma Linda Universtiy Adventist Health Sciences Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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