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The Safety and Efficacy of Belatacept, Daclizumab, and Sirolimus in Recipients of Non-HLA-Identical Living-Donor Renal Transplants (ITN023ST)

Phase 2
18 Years
65 Years
Not Enrolling
Transplantation, Kidney, End-Stage Renal Disease

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Trial Information

The Safety and Efficacy of Belatacept, Daclizumab, and Sirolimus in Recipients of Non-HLA-Identical Living-Donor Renal Transplants (ITN023ST)

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 a
medication schedule 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.

Inclusion Criteria:

- Receiving first kidney transplant

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

- Willing to use acceptable forms of contraception

Exclusion Criteria:

- Positive for antihuman 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.

- HIV infected

- Hepatitis B or C virus infected

- Other active infections

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

- Pregnancy or breastfeeding

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Acute Rejection at 6-Months

Outcome Description:

Cumulative incidence of acute rejection[1] at 6 months post-transplant based on local pathology biopsy reads Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999

Outcome Time Frame:

6 months post-transplant

Safety Issue:


Principal Investigator

Flavio Vincenti, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Food and Drug Administration

Study ID:




Start Date:

December 2006

Completion Date:

February 2010

Related Keywords:

  • Transplantation, Kidney
  • End-Stage Renal Disease
  • Kidney Transplant
  • Kidney Transplantation
  • Renal Transplant
  • Transplantation
  • Renal Transplantation
  • Kidney Failure
  • Renal Failure
  • Kidney Disease
  • Renal Disease
  • Living Donor
  • Kidney Diseases
  • Kidney Failure, Chronic



University of California, San FranciscoSan Francisco, California  94143
Emory UniversityAtlanta, Georgia  30322