Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02417870
• Other study ID #: 2015P000796
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: September 2015
• Est. completion date: April 2018

Study information

• Verified date: June 2021
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Biological:
• aldesleukin

Locations

Country	Name	City	State
United States	Anil Chandraker	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Anil K. Chandraker, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in Treg Count		6 weeks