Kidney Transplantation
Conditions
Keywords
Transplantation, interleukin-2, IL-2, Kidney, Renal
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.
Interventions
BIOLOGICALaldesleukin
Sponsors
Anil K. Chandraker, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in Treg Count | 6 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aldesleukin aldesleukin | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Aldesleukin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 2 / 2 |
| serious Total, serious adverse events | 1 / 2 |
Outcome results
Primary
Increase in Treg Count
Time frame: 6 weeks
Population: Study was termination prior to completion