NCT00298883

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

July 25, 2012

Status Verified

July 1, 2012

Enrollment Period

2.5 years

First QC Date

March 1, 2006

Last Update Submit

July 24, 2012

Conditions

End Stage Renal DiseaseKidney Transplantation

Keywords

RenalTransplantPRA

Outcome Measures

Primary Outcomes (1)

  • decrease in antibody reactivity

    six weeks

Secondary Outcomes (1)

  • CBC and CMP values </> 2 times normal

    six weeks

Study Arms (1)

Treatment

EXPERIMENTAL

This is a single arm, interventional trial.

Drug: Myfortic

Interventions

MyforticDRUG

Myfortic 360mg PO BID for six weeks

Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects unable to attend weekly clinic visits for six weeks
  • Inability to tolerate Myfortic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Shiro Fujita, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2006

First Posted

March 3, 2006

Study Start

February 1, 2006

Primary Completion

August 1, 2008

Study Completion

December 1, 2008

Last Updated

July 25, 2012

Record last verified: 2012-07

Locations

US(1)