Expired Study
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New Boston, New Hampshire 02115


Purpose:

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.


Criteria:

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.


NCT ID:

NCT02417870


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

New Boston, New Hampshire 02115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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