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Belatacept to Prevent Organ Rejection in Kidney Transplant Patients

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: Renal Transplant

Intervention: Belatacept (Drug); Sirolimus (Drug); Anti-thymocyte globulin (Drug); methylprednisolone (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Flavio Vincenti, MD, Principal Investigator, Affiliation: University of California, San Francisco
Christian Larsen, MD, Principal Investigator, Affiliation: Emory University

Summary

Belatacept is an experimental medication shown in clinical trials to have immune system suppression properties in people who have had renal (e. g., kidney) transplants. This study will determine whether a combination of anti-rejection drugs, including belatacept, can prevent the rejection of a first-time, non-human leukocyte antigen (HLA) identical renal transplant and allow patients to be safely withdrawn from anti-rejection therapy one year post-transplant.

Clinical Details

Official title: The Safety and Efficacy of Belatacept, Antithymocyte Globulin, and Sirolimus in Recipients of Non-HLA-identical Living-donor Renal Transplants (ITN023ST)

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Acute Rejection at 6-Months

Secondary outcome:

Participant Survival at 12 Months Post-Transplant

Acute Rejection at 12-Months

Tolerance Induction

Renal Function as Measured by Glomerular Filtration Rate (GFR) at 24 Weeks

Graft Survival at 12 Months Post-transplant

Time From Transplant to Acute Rejection

Proportion of Participants Requiring Antilymphocyte Therapy for Acute Rejection

Proportion of Participants With Post-transplant Infections

Proportion of Participants With Wound Complications

Proportion of Participants With Malignancies

Proportion of Participants With a Sirolimus Associated Adverse Event

Proportion of Participants With Chronic Allograft Nephropathy

Proportion of Participants With Delayed Graft Function

Proportion of Participants With Post-transplant Diabetes Mellitus

Detailed description: Drugs that suppress the immune system have contributed to increased success of transplantation; however, to prevent organ rejection, transplant recipients need to take immunosuppressive drugs for the rest of their lives. These drugs make patients more susceptible to infection and certain kinds of cancer. Belatacept is an experimental medication that specifically targets immune reactions against transplanted organs and has been shown to be effective in preventing kidney transplant rejection in previous clinical trials. Both thymoglobulin, an antibody, and sirolimus, an anti-rejection drug, prevent rejection by lowering the response of the immune system to the transplanted organ. This study will evaluate whether belatacept, along with thymoglobulin and sirolimus, is safe in kidney transplant patients. The study will also evaluate this regimen's potential to allow tapering and eventual discontinuation of all immunosuppressive drugs. This study will last up to 4 years. At the time of transplant, participants will begin an immunosuppressive treatment regimen consisting of thymoglobulin, sirolimus, and belatacept. Participants will receive infusions of thymoglobulin on days 1 through 4, and a combination of oral sirolimus (daily) and belatacept infusions at day 5, then weeks 2, 4, 8, and monthly for at least 2 years. Dose reduction of belatacept will occur at 12 weeks post-transplant. At Year 2, eligible participants may choose to begin drug withdrawal or continue study therapy through the end of the study. Study visits will occur weekly for the first two months, then monthly. These visits will include belatacept treatment, general medical assessments, blood and urine collection, and other assessments to determine overall health of the recipient's immune system and kidney transplant and to better understand the way the immune system works in the acceptance or rejection of organ transplants. *** IMPORTANT NOTICE: *** The National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network do not recommend the discontinuation of immunosuppressive therapy for recipients of cell, organ, or tissue transplants outside of physician-directed, controlled clinical studies. Discontinuation of prescribed immunosuppressive therapy can result in serious health consequences and should only be performed in certain rare circumstances, upon the recommendation and with the guidance of your health care provider.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Receiving first renal (e. g., kidney) transplant

- Transplant is from a non-HLA-identical living donor

- Willing to use acceptable forms of contraception

Exclusion Criteria:

- Positive for anti-human globulin (AHG) or T-cell cross-match with the donor

- Receiving multiple-organ transplant

- History of cancer within the 5 years prior to study entry. Patients who have certain

nonmelanoma skin cancers are not excluded

- Human immunodeficiency virus (HIV) infected

- Hepatitis B (HBV) or C (HCV) virus infected

- Other active infections

- Active tuberculosis (TB) infection within the 3 years prior to study entry

- Pregnancy or breastfeeding

Locations and Contacts

University of California, San Francisco, San Francisco, California 94143, United States

Emory University, Atlanta, Georgia 30322, United States

Additional Information

Immune Tolerance Network (ITN) Website

ITN TrialShare: open public access to participant-level data available for this trial

Related publications:

Vincenti F, Larsen C, Durrbach A, Wekerle T, Nashan B, Blancho G, Lang P, Grinyo J, Halloran PF, Solez K, Hagerty D, Levy E, Zhou W, Natarajan K, Charpentier B; Belatacept Study Group. Costimulation blockade with belatacept in renal transplantation. N Engl J Med. 2005 Aug 25;353(8):770-81.

Starting date: December 2006
Last updated: December 30, 2014

Page last updated: August 23, 2015

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