Study to Evaluate the Safety of Chronic Administration of... | NCT00928811

Studies
Study to Evaluate the Safety of Chronic Administration of Simulect to Subjects Receiving a First Kidney Transplant

NCT00928811

Sponsor

Drexel University College of Medicine

Status

Terminated

Last Update Posted

Feb 10, 2015Estimated

Enrollment

5Actual

Phase

Phase 2Phase 3

Conditions

End Stage Renal Disease

Interventions

basiliximab
basiliximab

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

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CHI 621A	Other Identifier	Drexel

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Investigator left University 04/2010

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Jun 25, 2009

First Submission Date that Met QC Criteria

Jun 25, 2009

First Posted Date

Jun 26, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

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

Feb 9, 2015

Last Update Posted Date

Feb 10, 2015Estimated

Name	Class
Novartis	INDUSTRY

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

The study is undertaken to explore the safety of using Simulect at monthly dose intervals to reduce the need of high dose/level CNI's such as Prograf.

Detailed Description

The use of CNI's after kidney transplantation is associated with typical adverse effects such as potential contribution to progressive impairment of renal function, hypertension, and metabolic abnormalities. The study consists of a run-in phase (1 month),and treatment phase (11 months) and safety assessment phase (1 month).

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Other	Standard of care administration with Simulect (basiliximab)being administered as per induction therapy on day of transplant and day 4.	Drug: basiliximab
Simulect	Experimental	Simulect (basiliximab) intravenously day of transplant and day 4. Chronic Simulect (basiliximab) administration monthly for one year duration. Concomitant decrease in Prograf administration.	Drug: basiliximab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
basiliximab	Drug	Simulect 20 mg intravenously day of transplant and day 4	Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the risk of sensitization against the chimeric antibody, Simulect.		one year

Secondary Outcomes

Measure	Description	Time Frame
To describe the pharmacokinetics of Simulect over the study course.		one year
To determine the absolute and relative number of CD25 receptors on T cells at the end of each dosing interval.		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female 18-75
First kidney transplant from a living or deceased donor
Receiving CNI and MPA
Able to tolerate full dose MPA
Calculated glomerular filtration rate >=30ml/min by Cockcroft-Gault equation
Able to tolerate renal graft biopsies
Provided written, informed consent
Females of childbearing potential must have a negative pregnancy test within 48 hours prior to the first Simulect administration

Exclusion Criteria:

Known hypersensitivity to Simulect
Current preformed PRA>10%
Multi organ or second kidney transplant
Use of any investigational immunosuppressive drug within 1 month of inclusion
Female patients who are pregnant, lactating or of child bearing potential and not practicing two approved methods of birth control
Known malignancy or history of malignancy other than excised basal or squamous cell carcinoma of the skin
HBV, HCV, or HIV positive patients
Current severe infection
Receiving an organ from an extended criteria donor per United Network for Organ Sharing (UNOS) guidelines
Dialysis dependent one month post transplant
Live too far away from the transplant center for adequate follow up

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mysore Anil S. Kumar, MD	Drexel University College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Drexel University College of Medicine		Philadelphia	Pennsylvania	19102	United States

Type	Date	Date Unknown
Release	Sep 15, 2016
Reset	Nov 1, 2016
Release	Jul 25, 2017
Reset	Aug 24, 2017

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077552	Basiliximab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 15, 2016			Nov 1, 2016
Jul 25, 2017