Desensitization of Renal Transplant Candidates | NCT00298883

Studies
Desensitization of Renal Transplant Candidates

NCT00298883

Sponsor

University of Florida

Status

Completed

Last Update Posted

Jul 25, 2012Estimated

Enrollment

9Actual

Phase

Phase 1

Conditions

End Stage Renal Disease
Kidney Transplantation

Interventions

Myfortic

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Aug 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Mar 1, 2006

First Submission Date that Met QC Criteria

Mar 1, 2006

First Posted Date

Mar 3, 2006Estimated

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

Jul 24, 2012

Last Update Posted Date

Jul 25, 2012Estimated

Name	Class
Novartis	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

Trial of the use of Myfortic to reduce anti-HLA alloantibody in patients waiting for renal transplantation.

Detailed Description

Pre-formed HLA antibodies prevent renal transplantation because of the risk of hyperacute rejection. We propose a prospective study evaluating the efficacy of Enteric Coated Mycophenolate Sodium (Myfortic) in decreasing the titers of anti-HLA alloantibodies in patients awaiting kidney transplantation. Myfortic is an immunosuppressant that inhibits the proliferation of B and T cells by blocking the enzyme inosine monophosphate dehydrogenase. We will attempt to determine whether a 6-week course of Myfortic adequately decreases the antibody reactivity to a level compatible with transplantation.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	This is a single arm, interventional trial.	Drug: Myfortic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Myfortic	Drug	Myfortic 360mg PO BID for six weeks	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
decrease in antibody reactivity		six weeks

Secondary Outcomes

Measure	Description	Time Frame
CBC and CMP values </> 2 times normal		six weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients on the deceased donor kidney transplant waiting list with panel reactive antibodies >50% and living donor waiting list patients who have a history of a positive crossmatch (donor-specific antibodies) will be eligible for the study.

Exclusion Criteria:

Any subjects not meeting the Inclusion Criteria
Subjects unable to attend weekly clinic visits for six weeks
Inability to tolerate Myfortic

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 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
Shiro Fujita, MD	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida		Gainesville	Florida	32610	United States

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
D009173	Mycophenolic Acid

Ancestor Terms

ID	Term
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided