Research Study of ATG and Rituximab in Renal Transplantation

• Status: Terminated
• Trial end date: 2017-08-25
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is see if a combination of two drugs, (ATG and rituximab), given at the time of the transplant surgery, will help reduce or eliminate the need for long term immunosuppressive medication.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Immune Tolerance Network (ITN)
• Treatments: Antilymphocyte Serum; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Rituximab; Sirolimus; Tacrolimus; Thymoglobulin

Criteria

Inclusion Criteria:

• Recipient of a first renal allograft from a single haplotype matched or greater living related donor who is no older than 65, or a second degree relative with an Human Leukocyte Antigen(HLA) type that is consistent with a single haplotype match with the recipient.

• Demonstration of absence of anti-HLA antibodies using solid phase micro particle technology (by Luminex® phenotype panel or Luminex single antigen bead test) performed 7 days or less prior to the first dose of rituximab, as assessed by local laboratories.No evidence of anti-HLA antibodies in current or past sera.Negative T- and B-cell crossmatch as determined by flow cytometric assay measured 7 days or less prior to the first dose of rituximab.

• Single-organ recipients (kidney only).

• Serologic evidence of prior exposure to Epstein-Barr virus (EBV).

• For women of childbearing potential: a negative serum or urine pregnancy test with sensitivity less than 50 mIU/m within 72 hours before the start of study medication.

• Use of FDA-approved methods of contraception (those with less than a 5% failure rate) by all participants from the time that study treatment begins until 104 weeks (24 months) after renal transplantation.

• Ability to receive oral medication.

• Ability to understand and provide informed consent.

Exclusion Criteria:

• Recipient of a kidney from a donor who is older than 65 years.

• History of cancer within the last 5 years, except for nonmelanoma skin cell cancers cured by local resection and cervical carcinoma in situ.

• Women who are breastfeeding.

• Uncontrolled hyperlipidemia (total serum cholesterol more than 300 mg/dL and/or triglycerides more than 400 mg/dL).

• Platelet count less than 100,000/μL at study entry.

• Seropositivity for HIV-1, Hepatitis C virus (HCV) (confirmed by HCV PCR), hepatitis B surface antigen, or Hepatitis B virus (HBV) core antibody (confirmed by HBV PCR).

• Active tuberculosis (TB) within the previous 3 years regardless of treatment history for TB. Participants with a known positive purified protein derivative (PPD) or positive Quantiferon assay will not be eligible for the study unless they have completed treatment for latent TB and have a negative chest x-ray at the time of enrollment. PPD testing or Quantiferon testing done within 52 weeks before transplant is acceptable as long as there is documentation of the results. Prior recipients of a Bacille Calmette-Guérin vaccination (BCG) are not exempt.

• Underlying renal disease with a high risk of disease recurrence in the transplanted kidney, including focal segmental glomerulosclerosis, types I or II membranoproliferative glomerulonephritis, and hemolytic-uremic syndrome/thrombotic thrombocytopenic purpura.

• The presence of any medical condition that the investigator deems incompatible with participation in the trial.

• Known sensitivity to antithymocyte globulin, rituximab, tacrolimus, sirolimus, MMF, or corticosteroids.

• Current use of systemic corticosteroids or antibody-based therapies (e.g., infliximab, adalimumab, or etanercept).

• Use of any investigational drug within 30 days of transplantation.

• Receipt of a live vaccine within 3 months of enrollment.