Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation | NCT02417870

Studies
Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation

NCT02417870

Sponsor

Anil K. Chandraker, MD

Status

Terminated

Last Update Posted

Jun 24, 2021Actual

Enrollment

2Actual

Phase

Phase 1Phase 2

Conditions

Kidney Transplantation

Interventions

aldesleukin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

Participant Flow Module

Pre-assignment Details

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of funding/resources

Expanded Access Info

Start Date

Sep 2015Actual

Primary Completion Date

Apr 2018Actual

Completion Date

Apr 2018Actual

First Submitted Date

Apr 13, 2015

First Submission Date that Met QC Criteria

Apr 15, 2015

First Posted Date

Apr 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

May 26, 2021

Results First Submitted that Met QC Criteria

Jun 23, 2021

Results First Posted Date

Jun 24, 2021Actual

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2021

Last Update Posted Date

Jun 24, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Label	Type	Description	Intervention Names
aldesleukin	Experimental		Biological: aldesleukin

Name	Type	Description	Arm Group Labels	Other Names
aldesleukin	Biological		aldesleukin	recombinant IL-2 recombinant interleukin-2 proleukin

Measure	Description	Time Frame
Increase in Treg Count		6 weeks

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Anil Chandraker		Boston	Massachusetts	02115	United States

ID	Title	Description
FG000	Aldesleukin	aldesleukin

Baseline Characteristics Module

Baseline Analysis Population Description

Not provided

Type of Units Analyzed

Not provided

Arm/Group Information

ID	Title	Description
BG000	Aldesleukin	aldesleukin

Denominators

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Increase in Treg Count

Study was termination prior to completion

Posted

6 weeks

ID	Title	Description
OG000	Aldesleukin	aldesleukin

Units	Counts
Participants	OG000

Adverse Events Module

Frequency Threshold

Time Frame

6 weeks

Description

Not provided

All-Cause Mortality Comment

Not provided

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Aldesleukin	aldesleukin	0

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
ischemic heart disease	Cardiac disorders		Non-systematic Assessment

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Elevated Creatinine	General disorders		Non-systematic Assessment	associated with advanced kidney disease and other comorbidities

More Info Module

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.

Certain Agreements

Are all PI(s) employees of the sponsor?

Yes

Point of Contact

Title	Organization	Phone	Extension	Email
Anil Chandraker	Brigham and Women's Hospital	617-732-7412		achandraker@bwh.harvard.edu

ID	Term
D007378	Interleukins
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides

ID	Term
C082598	aldesleukin
D007376	Interleukin-2