NCT01642225

Brief Summary

Purpose of the study: The specific aims of this study are to evaluate overall efficacy and safety of the pre-transplant IVIG treatment in our transplant center since 2007 and to identify factors affecting treatment outcomes in order to improve patient selection and treatment protocols for future patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

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

June 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 20, 2014

Status Verified

October 1, 2014

Enrollment Period

2 years

First QC Date

July 12, 2012

Last Update Submit

October 17, 2014

Conditions

Transplant; Failure, Kidney

Outcome Measures

Primary Outcomes (1)

  • Anti HLA antibody level

    after IVIG infusion

Secondary Outcomes (1)

  • Number of patients transplanted

    at the end of study

Eligibility Criteria

Age7 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Approximately 100 subjects are expected to participate from 2007 to current, and another 100 subjects are expected to participate during the next 12-month period.

You may qualify if:

  • Recent (\< 3 months) high levels of anti-HLA antibodies (at least one cPRA ≥ 40%).
  • Waiting time greater than 1 year for blood type AB, 2 years for blood types A, B, or O.

You may not qualify if:

  • Female subject is pregnant or lactating.
  • Subject has an uncontrolled concomitant infection or any other unstable medical condition (e.g., uncontrolled cardiovascular disease) that could interfere with the study objectives.
  • Subject has an uncontrolled active hepatitis B, hepatitis C, or HIV infection.
  • Subject has a current malignancy or a recent history of any malignancy that is deemed to be contraindicated to kidney transplantation.
  • Subject has a psychiatric illness that, in the judgment of caring physicians, may interfere with study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Study Officials

  • Junichiro Sageshima, M.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical

Study Record Dates

First Submitted

July 12, 2012

First Posted

July 17, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 20, 2014

Record last verified: 2014-10

Locations

US(1)