An Evaluation of IV Gamma Globulin As a Method to Improve Kidney Transplant Survival in Patients With End-Stage Renal Disease Who Are Highly Sensitized to Transplant Antigens
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: End-Stage Renal Disease; Kidney Transplantation
Intervention: Intravenous immune globulin (IVIG) (Biological)
Phase: Phase 3
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
This study is designed to test the clinical and laboratory observations that suggest IVIG
given before and after kidney transplant to patients who are sensitized (highly sensitive)
to certain transplant antigens could result in reduced sensitization and reduced rates of
Some ESRD patients are highly sensitive to certain transplant antigens (foreign substances
that activate the immune system) and must wait for a long time before a well-matched kidney
becomes available. Transplant rejection is more likely among highly sensitized patients
than in patients who are not highly sensitized. There is no proven method to improve a
highly-sensitized patient's chances of receiving and keeping a transplanted kidney.
Official title: Evaluation of Intravenous Gamma Globulin (IVIG) As an Agent to Lower Allosensitization and Improve Allograft Survival in Highly-Sensitized Adult End-Stage Renal Disease (ESRD) Patients (IG02)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Penalized months of dialysis during the study
Kidney transplantation is the treatment of choice for patients with end-stage renal disease
(ESRD). However, many patients do not receive this treatment due to immune sensitization to
HLA antigens. IVIG has been shown to somewhat reduce anti-HLA antibody activity. By blocking
this activity, IVIG may make transplants more feasible and increase graft survival in
Patients are randomized to receive IV infusion of either 2 g/kg (maximum dose 180 g) IVIG
10% S/D (Gamimune-N, 10%, manufactured by Bayer) or placebo (0. 1% human albumin,
manufactured by Bayer) at time of dialysis at study entry and monthly for 3 months. If
patients have not received a transplant at 1 year, they receive a "booster" dose of IVIG or
placebo; patients receive another booster at 24 months if transplant still has not occurred.
If transplant occurs, patients receive 2 g/kg (up to 180 g) IVIG or placebo monthly for 4
months, beginning at time of transplant. Before and after initiation of IVIG/albumin placebo
treatment, specific immune parameters, including panel reactive antibodies (PRA) levels,
MLR, serum inhibition of MLR, and cytokine gene transcription in the MLR, and AECA levels
are measured. Outcomes studied include time on dialysis and graft survival rates.
Minimum age: 12 Years.
Maximum age: N/A.
You may be eligible for this study if you:
- Are 12 years of age or older.
- Have end-stage renal disease.
- Currently receive either hemo- or peritoneal dialysis.
- Have an elevated (> 50%) level of panel reactive antibodies (PRA level) on 3
consecutive monthly tests.
- Agree to practice sexual abstinence or to use effective means of birth
control/contraception during the study and for 1 year after.
You will not be eligible for this study if you:
- Have received IVIG for any reason within 6 months prior to enrollment.
- Are HIV positive.
- Are Hepatitis B e-antigen/hepatitis B viral DNA-positive.
- Have selective IgA deficiency or have known antibodies to IgA.
- Are allergic to human immune globulin.
- Are pregnant or breast-feeding.
Locations and Contacts
Ann Limberger, Rockville, Maryland 20850, United States
National Institute of Allergy and Infectious Diseases (NIAID)
Last updated: February 1, 2013