NCT00275717

Brief Summary

This study is being done to collect blood and bone marrow samples for biologic studies of antibody producing cells. Donor specific antibodies can cause damage to the kidneys after they are transplanted. The study will look at the impact of immunosuppression on antibody production by antibody producing cells.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2005

Longer than P75 for all trials

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

March 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2006

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 22, 2010

Status Verified

December 1, 2010

Enrollment Period

5.8 years

First QC Date

January 10, 2006

Last Update Submit

December 20, 2010

Conditions

Kidney Transplant

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Three groups will be studied: 1. Non-sensitized renal allograft candidates prior to any therapy; 2. High DSA recipients--Recipients with a positive T or B cell cytotoxicity crossmatch or a B cell flow cytometric crossmatch assay with a channel shift \>350 at baseline against their living donor at baseline and 3. Low DSA recipients-recipients with a negative T and B cell cytotoxicity assay, but a positive T or B cell flow cytometric crossmatch with a B cell channel shift \<350.

Participants must be between the ages of 18 and 70 years of age and undergoing a kidney transplant.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Study Officials

  • Mark D. Stegall, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 12, 2006

Study Start

March 1, 2005

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 22, 2010

Record last verified: 2010-12

Locations

US(1)