Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation

• Sponsor: Anil K. Chandraker, MD (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02417870
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Actual Duration (Months): 31
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation	Biological: aldesleukin	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Treatment With Ultra-low Dose Subcutaneous IL-2 to Promote Regulatory T Cells Post Renal Transplantation
• Actual Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Apr 1, 2018
• Actual Study Completion Date: Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: aldesleukin	Biological: aldesleukin; Other Names: recombinant IL-2 recombinant interleukin-2 proleukin

Outcome Measures

Primary Outcome Measures

1. Increase in Treg Count [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anil Chandraker	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Anil K. Chandraker, MD

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 9, 2016

More Information

Publications

None provided.

• Responsible Party: Anil K. Chandraker, MD, Medical Director of Kidney and Pancreas Transplantation, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02417870
• Other Study ID Numbers: 2015P000796
• First Posted: Apr 16, 2015
• Last Update Posted: Jun 24, 2021
• Last Verified: Jun 1, 2021

• Keywords provided by Anil K. Chandraker, MD, Medical Director of Kidney and Pancreas Transplantation, Brigham and Women's Hospital: Transplantation; interleukin-2; IL-2; Kidney; Renal
• Additional relevant MeSH terms: Aldesleukin; Interleukin-2

Study Results

Participant Flow

Arm/Group Title	Aldesleukin
Arm/Group Description	aldesleukin
Period Title: Overall Study
STARTED	2
COMPLETED	0
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Aldesleukin
Arm/Group Description	aldesleukin
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 50%
>=65 years	1 50%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	2 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	2 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	2 100%

Outcome Measures

1. Primary Outcome

Title	Increase in Treg Count
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Study was termination prior to completion

Arm/Group Title	Aldesleukin
Arm/Group Description	aldesleukin
Measure Participants	0

Adverse Events

Time Frame	6 weeks
Arm/Group Title	Aldesleukin
Arm/Group Description	aldesleukin
All Cause Mortality
	Aldesleukin
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Serious Adverse Events
	Aldesleukin
	Affected / at Risk (%)	# Events
Total	1/2 (50%)
Cardiac disorders
ischemic heart disease	1/2 (50%)	1
Other (Not Including Serious) Adverse Events
	Aldesleukin
	Affected / at Risk (%)	# Events
Total	2/2 (100%)
General disorders
Elevated Creatinine	2/2 (100%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.