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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 Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about 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 conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. 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 Clinical research trials and 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 healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as 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. 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 Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a 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 clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their 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 condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: End-Stage Renal Disease,Kidney Transplantation
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 100
Location and Contact Information:
Ann Limberger
Rockville, Maryland, 20850
United States
Additional Information:
Study ID Numbers: DAIT IG02;
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000935
Other Kidney Transplantation Studies:
1. Prevention of Kidney Transplant Rejection
2. Kidney Transplants in People with HIV Infection
3. End- Stage Renal Disease – High Risk Transplant Recipients
4. A Study to Compare Treatment with Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant
5. Steroid Withdrawal in Pediatric Kidney Transplant Recipients
Related Studies:
Other Kidney Transplantation Clinical Trials
Other Maryland Clinical Trials
Other Rockville Clinical Trials
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
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