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Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation

Information source: Brigham and Women's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Transplantation

Intervention: aldesleukin (Biological)

Phase: Phase 1/Phase 2

Status: Not yet recruiting

Sponsored by: Anil K. Chandraker, MD

Overall contact:
Anil K Chandraker, MD, Phone: 617-732-7412, Email: achandraker@partners.org

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Increase in Treg count

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Locations and Contacts

Anil K Chandraker, MD, Phone: 617-732-7412, Email: achandraker@partners.org

Additional Information

Starting date: June 2015
Last updated: April 15, 2015

Page last updated: August 23, 2015

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