Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation

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.