Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation

Safety and Efficacy of Treatment With Ultra-low Dose Subcutaneous IL-2 to Promote Regulatory T Cells Post Renal Transplantation

To investigate the safety and tolerability of treatment with low dose rIL-2 in renal transplant recipients. To assess the immunologic impact of low dose rIL-2 in renal transplant recipients. To assess the efficacy of low dose rIL-2 in renal transplant recipients.

Inclusion Criteria:

• Kidney transplant recipients
• >18 years and <75 years of age
• >6 months post Tx
• on stable dose of immunosuppression
• Transplant biopsy showing interstitial fibrosis and tubular atrophy of grade II or greater, with some evidence of lymphocytic infiltration (biopsy is NOT a study procedure, it would be performed as part of the patient's SOC)
• Ability to give informed consent

Exclusion Criteria:

• Biopsy proven acute cellular rejection; greater than grade 1A
• Baseline creatinine >3.5mg/dL
• Patients with active infection, including Hepatitis B and C, HIV
• Current or prior invasive malignancy
• Patients who are pregnant or breastfeeding
• Patients who are unable to give consent
• Prior intolerance of/allergy to IL2
• Inability to comply with treatment
• History of thrombotic angiopathy including hemolytic uremic syndrome and thrombotic thrombocytopenic purpura
• Symptomatic congestive cardiac failure or uncontrolled cardiac angina
• Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
• WOCBP and male subjects with reproductive potential must agree to use a highly effective method of birth control [defined in protocol & ICF] during study treatment, and for 6 months after completion of treatment.