A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study

NCT ID: NCT01974999

Last Updated: 2019-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

184 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-07-31

Brief Summary

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This study is a multicenter, non-randomized, retrospective study to collect long term (5 years post-transplant) clinical outcome data to test whether the results of the noninvasive immune monitoring test strategy performed in the parent study (CTOT-01, NCT00308802) in first six-month post-transplant is predictive of 5-year outcomes. Each center will complete a retrospective chart review for the data on patient survival, graft survival and renal function.

Detailed Description

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Conditions

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Kidney Disease Kidney Failure End Stage Renal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Participants previously enrolled in the CTOT-01 study.
* Participants who are at least 5 years post-transplant (+/- 6 months), no later than March 31, 2014.

Exclusion Criteria

* Withdrawal of consent to continue in the CTOT-01 study.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Trials in Organ Transplantation

NETWORK

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter S Heeger, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Donald E Hricik, MD

Role: STUDY_CHAIR

University Hospitals Cleveland Medical Center

Locations

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Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Mount Sinai School of Medicine

New York, New York, United States

Site Status

University Hospitals of Cleveland

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Foundation, Glickman Urological Institute

Cleveland, Ohio, United States

Site Status

University of Manitoba Health Sciences Centre

Winnipeg, Manitoba, Canada

Site Status

Children's Hospital of Winnipeg

Winnipeg, Manitoba, Canada

Site Status

Countries

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United States Canada

References

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Faddoul G, Nadkarni GN, Bridges ND, Goebel J, Hricik DE, Formica R, Menon MC, Morrison Y, Murphy B, Newell K, Nickerson P, Poggio ED, Rush D, Heeger PS; CTOT-17 consortium. Analysis of Biomarkers Within the Initial 2 Years Posttransplant and 5-Year Kidney Transplant Outcomes: Results From Clinical Trials in Organ Transplantation-17. Transplantation. 2018 Apr;102(4):673-680. doi: 10.1097/TP.0000000000002026.

Reference Type RESULT
PMID: 29189482 (View on PubMed)

Related Links

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https://www.niaid.nih.gov/

National Institute of Allergy and Infectious Diseases (NIAID)

https://www.niaid.nih.gov/about/dait

Division of Allergy, Immunology, and Transplantation (DAIT)

http://www.ctotstudies.org/

Clinical Trials in Organ Transplantation (CTOT)

Other Identifiers

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DAIT CTOT-17

Identifier Type: -

Identifier Source: org_study_id

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