Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation

Stopped early · Phase 1/Phase 2

Conditions studied: Kidney Transplantation

In brief

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.

Key facts

Study ID

NCT02417870

Run by

Anil K. Chandraker, MD

People needed

2

Starts

2015-09-01

Expected to finish

2018-04-01

Last updated by the study team

2021-06-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Anil Chandraker — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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