A phase 2 evaluation for patients who undego kidney transplant requires long term theraphy that suppress immune response to prevent damage rejection by stopping the immune system from attacking the healthy tissues in the body.

Subjects with Epstein Barr virus (EBV) status negative or unknown. EBV serostatus positivity at screening is to be determined locally by two methods: anti-VCA IgG and anti-EBNA IgG. Both results must be positive for subject eligibility. Genetically-identical donor recipient pairs (ie, identical twins) Subjects with a recent (within 3 months prior to transplant) PRA more than or equal to 20%. Subjects in need of desensitization therapy. Subjects with previous graft loss due to acute rejection Subjects with a positive T-cell or B-cell cross match. Recipients of kidneys from donors < 10 years old. Recipients of extended criteria deceased donor (ECD) kidney, defined as: -Donors more than or equal to 60 years old, or -Donors aged 50 – 59 years and any 2 of the following: death from cerebrovascular accident; hypertension; serum creatinine > 1.5 mg/dL; or -Anticipated cold ischemia time more than or equal to 24 h, or -Recipients of kidneys from deceased donors after cardiac death. Subjects with prior or concurrent non-renal solid organ or cell transplant (eg, pancreas or kidney-pancreas, islet transplant or stem-cell) or deemed by the Investigator likely to have a non-renal transplant in the next 3 years.Subjects receiving paired kidneys (dual or en bloc kidney transplants). Hepatitis C virus (HCV): subjects or donors known to be positive for hepatitis C antibody or polymerase chain reaction (PCR). Hepatitis B virus (HBV): subjects or donors known to be positive for hepatitis B surface antigen or PCR. Human immunodeficiency virus (HIV): subjects or donors known to be HIV positive. Subjects must be screened for active and latent tuberculosis (TB): -Subjects must have documentation of a chest x-ray (posterior-anterior and lateral views) within the last 6 months prior to transplant. -Subjects who do not have documented results from an IGRA test performed within the last 3 months must be screened for latent TB with an Interferon gamma release assay (IGRA) test, such as QuantiFERON® TB Gold test or T-Spot®- TB. Note: Results of IGRA are not required for randomization. If the Screnning IGRA test result is positive and there is no historical negative screening test (PPD or IGRA) result for LTBI available so that the patient is a screen failure, the patient may be re-screened after completion of standard of care therapy for LTBI, if the only screen fail cause was Positive IGRA test result. IGRA test is to be done by central laboratories. However, if equipment for sample preparation prior to shipment to central lab is not available at the site, a local lab IGRA test is acceptable. If IGRA is positive, treatment for latent TB must be initiated upon receipt of the test result by the Investigator. Treatment consists of daily doses of 300 mg of isoniazid (INH) for 9 months. History of malignancy in the previous 5 years (other than nonmelanoma skin cancer cured by resection). Subjects with a body mass index (BMI) > 30 kg/m2 at screening (due to higher risk of wound complications). Subjects whose life expectancy is severely limited by disease state or other underlying medical condition. Subjects with a current or past history of substance abuse (drug or alcohol) within the past 5 years, or psychotic disorders that are not compatible with adequate study adherence and follow-up. Subjects with active peptic ulcer disease, chronic diarrhea, or gastrointestinal malabsorption. Subjects with any active infection or other contraindication that would

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A phase 2 evaluation for patients who undego kidney transplant requires long term theraphy that suppress immune response to prevent damage rejection by stopping the immune system from attacking the healthy tissues in the body.

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