Advertisement

Topics

Study of Tolerant Kidney Transplant Patients

2014-08-27 03:54:23 | BioPortfolio

Summary

This study will investigate tolerance in kidney transplant patients. One of the most common complications of kidney transplantation is organ rejection, which occurs because the body's immune system tries to attack (reject) the newly transplanted kidney. To prevent this, patients are given immunosuppressive, or anti-rejection, drugs. Most patients who stop taking these drugs reject their transplanted kidney; however, some patients do not reject the transplanted kidney and it continues to work well. These patients are said to "tolerate" the transplanted kidney, and this condition is referred to as tolerance. This study will establish a database of clinical and laboratory information that may help to identify unique characteristics of tolerant patients.

Patients 18 years of age and older who have had a kidney transplant and people who donated their kidneys for these patients may be eligible for this study. Patients are divided into 6 groups, according to the medicines they are currently taking and the status of their kidney function. A seventh group comprises patients who received a kidney from an identical twin, and an eighth group comprises kidney donors. Patients are screened with a medical history and a skin test to determine how well their immune system responds to foreign substances.

Patients in group 1 (patients who have stopped taking immunosuppressive medications for at least 1 year and whose transplanted kidney functions in a normal and stable manner) are required only to undergo the screening assessment, but may choose to participate in the following procedures, which are required for groups 2-7:

- Baseline visit - Review of medical history and demographic information; routine blood tests; 24-hour urine sample; blood draw by standard method (phlebotomy) or by leukapheresis for tolerance tests. For leukapheresis, a needle is placed in a vein in each arm. Blood is collected from one arm and directed to a machine that separates it into its components. Some of the white blood cells are removed, and the rest of the blood is returned to the patient through the needle in the other arm.

- Visits 1-6 (months 6, 12, 18, 24, and 36) - Review of medical history, including status of transplanted kidney; blood and urine samples for routine laboratory tests. If kidney function declines during the course of the study, patients will be asked to provide: additional blood and urine samples for routine laboratory tests; a 24-hour urine sample; and blood for tolerance tests, collected by standard phlebotomy or leukapheresis.

Patients in all groups may be asked to provide a biopsy sample of their transplanted kidney for tolerance assays and for microscopic examination. The biopsy may be repeated if kidney function worsens. For this procedure, a small piece of the transplanted kidney is removed with a special needle. Biopsies are an optional procedure.

Kidney donors provide blood samples for tolerance assays. They may be asked to provide additional samples if the kidney they donated deteriorates in function. The donor may choose to provide the blood sample by leukapheresis or by phlebotomy.

Description

This study is designed to obtain information from Kidney Transplant recipients and donors that will help scientists understand those factors causing and preventing transplant rejection. Approximately 210 renal transplant recipients and donors will be recruited into the study. The recruitment period for this study will be for 3 years after the first participant is enrolled. Based on the Network Executive Committee (NEC) and Tolerance Assay Sub-Group's annual review of the recruitment status of the study, the recruitment period may be adjusted. Participants will be classified into one of eight study groups and, once the participant has been assigned to a particular group, they will remain in that group until the end of the trial, regardless of change of status during the course of the study.

Each participant will be asked to provide consent for the collection of extensive demographic/clinical information and medical histories, and blood, urine and tissue (biopsy) samples upon study entry and during the study depending on the study group. Blood, urine and tissue samples (when provided) will be used to perform specific assays, to help define mechanism(s) of tolerance. In addition, specimens collected may be archived for use in future research assays. Participants will be asked to provide permission before any specimens are utilized in future research not described within this protocol. Information will be obtained regarding the donor of the renal allograft from the recipient's medical records. Living donors may be informed of this study by the recipient of their organ. The donor of the renal allograft may then contact study personnel if they are interested in participating in the study. The donor participants will be asked to consent to joining the study and asked to provide medical histories and blood samples. Information and archived blood and/or tissue samples from cadaveric donors will be requested from the Organ Procurement Organization (OPO) or UNOS (United Network for Organ Sharing) based on the unique UNOS number assigned to the donated kidney.

Study Design

N/A

Conditions

Immune System Diseases

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda
Maryland
United States
20892

Status

Completed

Source

National Institutes of Health Clinical Center (CC)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:23-0400

Clinical Trials [1241 Associated Clinical Trials listed on BioPortfolio]

Evaluation of the Efficacy of Hydroxychloroquine in Decreasing Immune Activation in Asymptomatic HIV-infected Patients

The purpose of this pilot study is to find out if taking hydroxychloroquine will decrease immune activation (stimulation of the body's defence system) in people with early HIV infection. H...

Investigating the Immune System in chrONIC Kidney Disease.

This study will investigate the function of the immune system in people with chronic kidney disease (CKD) compared to people with normal kidneys. The investigators will use standard vacci...

Immunological Profiles in Inflammatory Bowel Disease

Inflammatory Bowel Diseases (IBD) is a heterogeneous group of diseases regarding clinical presentation, disease course and treatment response. Pathogenesis is complex and multifactorial, b...

Studies of the Immune Response in Normal Subjects and Patients With Disorders of the Immune System

The goal of the protocol is to define the normal humoral and cellular immune responses to antigens in volunteers and to define abnormalities of these immune responses in patients with immu...

Treatment of Childhood Onset Psychiatric Disorders With Intravenous Immunoglobulin (IVIg)

Recent research studies of early onset-obsessive compulsive disorder (OCD) and Tourette's syndrome have questioned whether autoimmunity could play a role in the development of these condit...

PubMed Articles [19773 Associated PubMed Articles listed on BioPortfolio]

Deciphering Sex Differences in the Immune System and Depression.

Certain mood disorders and autoimmune diseases are predominately female diseases but we do not know why. Here, we explore the relationship between depression and the immune system from a sex-based per...

Similarity and Differences in Inflammation-Related Characteristics of the Peripheral Immune System of Patients with Parkinson's and Alzheimer's Diseases.

Parkinson's disease (PD) and Alzheimer's disease (AD) are the most common age-related neurodegenerative disorders. Both diseases are characterized by chronic inflammation in the brain-neuroinflammatio...

CNS inflammation and neurodegeneration.

There is an increasing recognition that inflammation plays a critical role in neurodegenerative diseases of the CNS, including Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease, ...

The Role of the Immune System in Alzheimer Disease: Etiology and Treatment.

The immune system is now considered a major factor in Alzheimer Disease (AD). This review seeks to demonstrate how various aspects of the immune system, both in the brain and peripherally, interact to...

Immunity - a significant pathogenic factor as well as an integral part of the sychoneuroendocrine-immune regulations.

Immunity plays an important role in the reactivity of the organism and, in this context, is an essential factor in the pathogenesis of many diseases. Basically, there is no system or organ in the body...

Medical and Biotech [MESH] Definitions

Group of diseases mediated by the deposition of large soluble complexes of antigen and antibody with resultant damage to tissue. Besides SERUM SICKNESS and the ARTHUS REACTION, evidence supports a pathogenic role for immune complexes in many other IMMUNE SYSTEM DISEASES including GLOMERULONEPHRITIS, systemic lupus erythematosus (LUPUS ERYTHEMATOSUS, SYSTEMIC) and POLYARTERITIS NODOSA.

Disorders caused by cellular or humoral immune responses primarily directed towards nervous system autoantigens. The immune response may be directed towards specific tissue components (e.g., myelin) and may be limited to the central nervous system (e.g., MULTIPLE SCLEROSIS) or the peripheral nervous system (e.g., GUILLAIN-BARRE SYNDROME).

The biochemical and electrophysiological interactions between the NERVOUS SYSTEM and IMMUNE SYSTEM that result in regulation of the immune system by the nervous system.

The theory that infectious agents, symbiotic microorganisms, and parasites are normal stimulants for the maturation of the immune system toward a balanced immune response. The theory predicts that lack of such stimulation leads to allergies and AUTOIMMUNE DISEASES.

Alteration of the immune system or of an immune response by agents that activate or suppress its function. This can include IMMUNIZATION or administration of immunomodulatory drugs. Immunomodulation can also encompass non-therapeutic alteration of the immune system effected by endogenous or exogenous substances.

More From BioPortfolio on "Study of Tolerant Kidney Transplant Patients"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nephrology - kidney function
Nephrology is a specialty of medicine and pediatrics that concerns itself with the study of normal kidney function, kidney problems, the treatment of kidney problems and renal replacement therapy (dialysis and kidney transplantation). Systemic conditions...

Antibodies
An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...


Searches Linking to this Trial