Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation

NCT02417870 | Terminated Phase 1 Results DMC

• 1 other identifier: 2015P000796
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplantation

Keywords

Transplantation; interleukin-2; IL-2; Kidney; Renal

Outcome Measures

Primary Outcomes (1)

• Increase in Treg Count

  6 weeks

Study Arms (1)

aldesleukin

EXPERIMENTAL

Biological: aldesleukin

Interventions

aldesleukin BIOLOGICAL

Also known as: recombinant IL-2, recombinant interleukin-2, proleukin

aldesleukin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Anil K. Chandraker, MD: lead

Study Sites (1)

Anil Chandraker

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

aldesleukin; Interleukin-2

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Limitations and Caveats

Both enrolled subjects were discontinued prior to completion due to adverse events associated with advanced kidney disease and other comorbidities. The study was closed to enrollment in 2017 and ultimately terminated prior to completion.

Results Point of Contact

• Title: Anil Chandraker
• Organization: Brigham and Women's Hospital

achandraker@bwh.harvard.edu

617-732-7412

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director of Kidney and Pancreas Transplantation

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: April 16, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: June 24, 2021
• Results First Posted: June 24, 2021

Record last verified: 2021-06

Locations

US (1)