NCT00018785

Brief Summary

Diabetes and end-stage kidney, liver and heart disease are prominent health issues among veteran patients. Successful solid organ transplantation in the absence of chronic immunosuppressive therapy (specific acquired immunological tolerance) is a desirable therapeutic option. This project extends recent observations supporting the use of concommitant donor bone marrow cell infusion as a means of modulating the immune response in kidney transplantation, thereby allowing a substantial decrease or withdrawal of potentially toxic immunosuppressive drugs.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 1998

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1998

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2001

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
Last Updated

January 21, 2009

Status Verified

December 1, 2004

First QC Date

July 3, 2001

Last Update Submit

January 20, 2009

Conditions

Kidney Disease

Keywords

kidney transplantationimmunosuppressionbone marrow

Interventions

donor bone marrow infusionPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Living related donor kidney transplant recipients and the living related donors.

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

Sponsors & Collaborators

Study Sites (1)

VAMC Miami

Miami, Florida, 33125, United States

Location

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Camillo Ricordi, M.D.

  • Andreas Tzakis, M.D.

  • Violet Esquenazi, Ph.D.

  • Keith Zucker, Ph.D.

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

July 3, 2001

First Posted

July 5, 2001

Study Start

October 1, 1998

Study Completion

September 1, 2003

Last Updated

January 21, 2009

Record last verified: 2004-12

Locations

US(1)