Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation

Anil K. Chandraker, MD

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Kidney Transplantation

Treatments

Biological: aldesleukin

Study type

Interventional

Funder types

Other

Identifiers

NCT02417870

2015P000796

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.