NCT01163578

Brief Summary

The objective of this study is to evaluate whether certain proteins, expressed in biological tissues can indict a better understanding of the effect of drugs that are used to treat rejection, and of processes leading to rejection and rejection-free outcomes.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
46mo left

Started Mar 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress85%
Mar 2005Mar 2030

Study Start

First participant enrolled

March 1, 2005

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2010

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed
19.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

25 years

First QC Date

June 29, 2010

Last Update Submit

September 5, 2025

Conditions

Keywords

TransplantationRejection

Outcome Measures

Primary Outcomes (1)

  • Rejection

    Biopsy-proven acute cellular rejection

    90 day post transplantation (clinical severity)

Secondary Outcomes (1)

  • Thresholds of immunosuppression

    Yearly post transplantation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals who are listed and or recipients of solid organ or bone marrow transplantation.

You may qualify if:

  • Recipients of abdominal, thoracic and bone marrow allografts that are receiving inpatient and outpatient follow-up with routine laboratory tests at the University of Pittsburgh Medical Center.
  • All Ages
  • Subject or parents are able to read and understand the informed consent

You may not qualify if:

  • Subjects and/or their parents who are unable to read and understand informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Related Publications (2)

  • Ashokkumar C, Sun Q, Ningappa M, Higgs BW, Mazariegos G, Zeevi A, Sindhi R. Antithymocyte globulin facilitates alloreactive T-cell apoptosis by means of caspase-3: potential implications for monitoring rejection-free outcomes. Transplantation. 2015 Jan;99(1):164-70. doi: 10.1097/TP.0000000000000289.

  • Ashokkumar C, Gabriellan A, Ningappa M, Mazariegos G, Sun Q, Sindhi R. Increased monocyte expression of sialoadhesin during acute cellular rejection and other enteritides after intestine transplantation in children. Transplantation. 2012 Mar 15;93(5):561-4. doi: 10.1097/TP.0b013e3182449189.

Biospecimen

Retention: SAMPLES WITH DNA

blood, saliva, intestinal and liver biospy samples, urine, stool

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Rakesh Sindhi, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Morgan L Paul, BSN

CONTACT

Daniel Pieratt, MPA

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

June 29, 2010

First Posted

July 15, 2010

Study Start

March 1, 2005

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2030

Last Updated

September 9, 2025

Record last verified: 2025-09

Locations