- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000935
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
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)
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 kidney rejection.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 transplant recipients.
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Maryland
-
Rockville, Maryland, United States, 20850
- Ann Limberger
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
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.
Exclusion Criteria
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intravenous Immune Globulin (Human)
|
given at a dose of 20mL/kg Intravenous Immune Globulin (Human) (IVIG 10% solvent/detergent)
|
Placebo Comparator: Intravenous Immune Globulin (Human) Placebo
|
given at a dose of 20mL/kg Intravenous Immune Globulin (Human) (IVIG 10% solvent/detergent)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Penalized months of dialysis during the study
Time Frame: 1 year post transplant
|
1 year post transplant
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stanley Jordan, MD, Department of Pediatrics, Cedars-Sinai Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DAIT IG02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
-
Individual Participant Data Set
Information identifier: SDY355Information comments: ImmPort study identifier is SDY355.
-
Study Protocol
Information identifier: SDY355Information comments: ImmPort study identifier is SDY355.
-
Study summary, -design, -demographics, -lab tests, -study files
Information identifier: SDY355Information comments: ImmPort study identifier is SDY355.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Kidney Transplantation
-
Astellas Pharma IncAstellas Pharma Europe B.V.CompletedKidney Transplantation | Renal Transplantation | Transplantation, Kidney | Grafting, Kidney | Transplantation, RenalBelgium, Germany, Spain, Sweden, Italy, Switzerland, United Kingdom, Austria, France, Poland, Czech Republic, Netherlands
-
Bristol-Myers SquibbCompletedKidney Transplantation: Transplantation, Kidney
-
Nantes University HospitalTerminated
-
Hospices Civils de LyonCompletedKidney Transplantation | Pancreas-kidney TransplantationFrance
-
Astellas Pharma Europe Ltd.CompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationCzechia, France, Italy, Poland, United Kingdom
-
The Hospital for Sick ChildrenCompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationCanada
-
Astellas Pharma Europe Ltd.TerminatedLiver Transplantation | Kidney Transplantation | Heart TransplantationBelgium, France, Germany, Poland, Spain, United Kingdom
-
Astellas Pharma Europe Ltd.CompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationSpain, Australia, France, Germany, Canada, Italy, United Kingdom, Belgium, South Africa, Switzerland, Sweden, United States, Austria, Brazil, Czechia, Denmark, Finland, Hungary, Ireland, Mexico, Netherlands, New Zealand, Poland
-
Astellas Pharma Europe Ltd.CompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationBelgium, France, Germany, Poland, Spain, United Kingdom
-
Medical University of ViennaUnknownKidney Function After Transplantation | Outcome After Kidney Transplantation
Clinical Trials on Intravenous immune globulin (IVIG)
-
NYU Langone HealthLupus Research AllianceCompletedCongenital Heart Block | Neonatal Lupus | Autoantibody-associated Heart BlockUnited States
-
Green Cross CorporationAtlantic Research GroupCompletedImmunologic Deficiency SyndromeUnited States, Canada
-
Rutgers, The State University of New JerseyRecruitingChronic Inflammatory Demyelinating Polyneuropathy | CIDP | Immunoglobulin DeficiencyUnited States
-
University of South FloridaBaxter Healthcare CorporationUnknownSpinocerebellar AtaxiasUnited States
-
The University of Hong KongQueen Elizabeth Hospital, Hong Kong; Queen Mary Hospital, Hong Kong; Pamela Youde... and other collaboratorsCompleted
-
Columbia UniversityGrifols Therapeutics LLCCompletedLung Transplantation | HypogammaglobulinemiaUnited States
-
Vera BrilUnknownChronic Inflammatory Demyelinating Polyneuropathy (CIDP)Canada
-
Tongji HospitalRecruitingHFRS (Hemorrhagic Fever With Renal Syndrome)China
-
Johns Hopkins UniversityTerminatedAutoimmunity | Dysmotility SyndromeUnited States