NCT00419575

Completed

Renal Transplantation With Immune Monitoring

Washington University School of Medicine Source

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Other study identifiers

Sponsor study identifier

06-0867

Study Type

observational

Estimated enrollment

60

Locations

1 country

Sites

1

Timeline

Study Start

October 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

May 2008

Actual (reported)

Brief Summary

The aim of this observational study is to evaluate an FDA approved immune system monitoring assay (Immunknow, Cylex Inc. Columbia, MD) in renal transplant recipients using standard immunosuppression and prophylaxis protocols from the time of transplantation through a twelve month follow-up period. The primary endpoint will be the incidence of acute rejection and infection and any correlation of these events to an assay that may be a measure of recipient immune response. Secondary endpoints will include evaluation of renal function, patient and graft survival, incidence of post-transplantation lymphoproliferative disorder and duration and extent of lymphocyte depletion.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 60 participants
Study completion date: May 2008
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 2006
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
January 5, 2007
Actual (reported)
First Posted
January 8, 2007
Actual (reported)
Study Completion
May 2008
Actual (reported)

Last Updated: June 5, 2008
Status Verified: June 2008
Last Update Submitted: June 4, 2008

Conditions

Immunosuppression Renal Transplantation

Keywords

renaltransplantationimmunosuppressionmonitoring

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Kidney transplant recipients.

You may qualify if:

All consenting adult renal transplant recipients (age 18 years of age or older)
Females of childbearing age must have a negative pregnancy test performed at the time of admission for transplantation
Patient or guardian agrees to participate in the study and signs the informed consent.
Patients already consented to another study, if allowed by the study sponsor and PI of that study.

You may not qualify if:

Sponsors & Collaborators

Washington University School of Medicine
Otherlead

Study Sites (1)

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Study Officials

Matthew J Koch, MD
Washington University School of Medicine
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER

Study Record Dates

First Submitted

January 5, 2007

First Posted

January 8, 2007

Study Start

October 2006

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

May 2008

Actual (reported)

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Completed

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Phase 2Completed

NCT00768729

Safety of Immunosuppression Minimization in Children and Adolescents After Kidney Transplantation

Phase 1Completed

NCT00619528

HLA-Identical Sibling Renal Transplant Tolerance

Not ApplicableCompleted

Pregnant women or nursing mothers

Any patient who, in the opinion of the investigator, has a significant medical or psychosocial problem that should preclude them from the study.

Contact the study team to confirm eligibility.

Last Updated

June 5, 2008

Record last verified: 2008-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00419575
Data provider: ClinicalTrials.gov
Source updated: 2008-06-05
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:09 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Study Design

Study Record Dates

Source record

Locations