Clinical Trials for

Gradual Withdrawal of Immunosuppression in Patients Receiving a Liver Transplant (AWISH)

itn_admin — Thu, 31 Jul 2008 12:55:59 -0700

It is possible that tolerance induction may be occurring in a significant number of liver transplant recipients already as a result of variables intrinsic to the organ. In these individuals, tolerance was achieved either after abrupt discontinuation of immunosuppression, or following gradual weaning of immunosuppression long after transplantation. Importantly, the occurrence of rejection during weaning was reversed by reinstitution of immunosuppression, and did not result in a significant long-term damage to the graft.

Study of Thymoglobulin to Arrest Type 1 Diabetes (START)

itn_admin — Thu, 31 Jul 2008 15:35:57 -0700

Type 1 diabetes mellitus (T1DM) is an autoimmune disorder that results from T-cell mediated destruction of insulin producing beta cells. It is not currently possible to identify the majority of subjects who will develop T1DM in the general population in a pre-clinical phase of the disease. Yet, at the time of diagnosis, at least 10-20% of beta cell function remains, and endogenous insulin secretion at this stage often results in near normal metabolic control.

A Phase I Trial of IL-2 and Sirolimus in Recent-onset Type 1 Diabetes Mellitus

itn_admin — Thu, 31 Jul 2008 15:52:04 -0700

Hypothesis: Combination therapy with IL-2 (Proleukin®) and rapamycin (Rapamune®) is safe, and will arrest pancreatic islet β-cell destruction in subjects with new-onset T1D, thereby preserving the residual β-cell mass and improving blood glucose control.

ITN Registry of Tolerant Kidney Transplant Recipients

itn_admin — Thu, 31 Jul 2008 16:00:40 -0700

The objectives of this study are: (1) to identify patients who are functionally tolerant following kidney transplantation as well as relevant groups for comparison, (2) to enter demographic and clinical data from these patients into an electronic database thereby creating a registry of tolerant kidney transplant recipients in order to facilitate subsequent mechanistic studies, and (3) to use cutting edge research technologies to define surrogate markers of tolerance and gain new insights into immune mechanisms underlying tolerance induction in humans.

Cytokine production in blood leukocytes of prediabetic children and effect of intranasal insulin

itn_admin — Thu, 31 Jul 2008 16:02:43 -0700

Objectives: The aim of the study is to create assays able to detect the beginning of islet cell specific cellular immune response, the destructive capacity of this response, and its natural development as well as the possible effect of intranasal insulin treatment on the direction of this response.

Abatacept and Cyclophosphamide Combination: Efficacy and Safety Study (ACCESS) for Lupus Nephritis

itn_admin — Tue, 16 Dec 2008 12:16:03 -0800

The current treatment for SLE patients with class III and class IV glomerulonephritis consists of high doses of corticosteroids, often accompanied by the cytotoxic agents cyclophosphamide or mycophenolate mofetil. Despite this aggressive therapy, 65%–90% of patients do not achieve remission within 6 months. Even if treatment is continued for 24 months, approximately one-third of SLE patients have an inadequate response. Moreover, significant adverse events (AEs) are common, especially with long-duration therapy. Clearly, safer and more effective therapies are needed for SLE.

Renal Allograft Tolerance through Mixed Chimerism

lstraub — Wed, 10 Mar 2010 08:43:50 -0800

Basis/Rationale: Evidence that tolerance can occur in humans is illustrated by the fact that recipients of successful allogenic bone marrow transplants with end-stage renal disease have undergone kidney transplantation from the same donor without the need for immunosuppressive therapy. However, full allogenic bone marrow transplantation for routine use, specifically for the induction of functional tolerance to a solid organ allograft, is neither necessary or desirable.