TerminatedNCT02417870Updated Jun 24, 2021Results posted

Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation

A Phase 1/2 interventional study of aldesleukin in Kidney Transplantation, sponsored by Anil K. Chandraker, MD. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-06-24.

Sponsored by Anil K. Chandraker, MD · Phase 1/2, Interventional, and Treatment

Why this study was terminated

lack of funding/resources

Phase: Phase 1/2
Study type: Interventional
Enrollment: 2
Allocation: Not applicable
Ages: 18 Years to 75 Years
Sex: All

Study 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 studied

Kidney Transplantation

Keywords

Transplantation
interleukin-2
IL-2
Kidney
Renal

In context

Lead sponsor

This is the only study on the registry with Anil K. Chandraker, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 2 participants (actual)

Study arms

Experimental
aldesleukin
Biological: aldesleukin

Interventions

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

What researchers measure

Primary outcomes

Increase in Treg Count
Time frame: 6 weeks

Results

Posted Jun 24, 2021

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.

Participant flow

Participant flow — Overall Study
Milestone	Aldesleukin
Started	2
Completed	0
Not completed	2

Outcome measures

PrimaryIncrease in Treg Count

Time frame:: 6 weeks

No measurements were reported for this outcome.

Adverse events

Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Aldesleukin	0/2 (0%)	1/2 (50%)	2/2 (100%)

Most frequent serious events

Most frequent serious events
Event	Aldesleukin
ischemic heart diseaseCardiac disorders	1/2

Most frequent other events

Most frequent other events
Event	Aldesleukin
Elevated CreatinineGeneral disorders	2/2

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Aldesleukin
<=18 years	0
Between 18 and 65 years	1
>=65 years	1

Sex: Female, Male
Sex: Female, Male(Participants)	Aldesleukin
Female	0
Male	2

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Aldesleukin
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	2
More than one race	0
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(participants)	Aldesleukin
United States	2

Study locations

1 site

Anil Chandraker
Boston, Massachusetts 02115, United States

References and documents

Study documents

Protocol and statistical analysis plan · May 9, 2016

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02417870
Lead sponsor: Anil K. Chandraker, MD
Responsible party: Anil K. Chandraker, MD (Medical Director of Kidney and Pancreas Transplantation, Brigham and Women's Hospital) — Sponsor-investigator
First posted: Apr 16, 2015
Start date: Sep 2015
Primary completion: Apr 2018
Completion: Apr 2018
Results posted: Jun 24, 2021
Last update: Jun 24, 2021

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Aldesleukin

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