NCT01289717

Brief Summary

There is a need to develop blood and/or urine tests that will help to detect early signs of rejection in people who have had kidney transplant. Researchers will examine blood, urine, and tissue samples and try to identify genetic markers for certain conditions like rejection, response to therapy, and scarring of the kidney. By studying gene patterns, researchers hope to be able to diagnose these conditions earlier and improve kidney survival.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
307

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

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

First Submitted

Initial submission to the registry

February 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 4, 2011

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

Enrollment Period

5.3 years

First QC Date

February 2, 2011

Last Update Submit

August 10, 2017

Conditions

Kidney TransplantKidney Transplantation

Keywords

biomarkersproteogenomic profilingacute rejectionchronic allograft nephropathy/interstitial fibrosis and tubular atrophy

Outcome Measures

Primary Outcomes (1)

  • Incidence of Biopsy Proven Acute Rejection (AR)-Clinical and Sub-Clinical), Chronic Allograft Nephropathy/Interstitial Fibrosis and Tubular Atrophy (CAN/IFTA), and Normal Renal Biopsy with Stable, Good Kidney Function

    12 and 24 months

Secondary Outcomes (12)

  • Incidence of Death

    Baseline to month 24

  • Incidence of Graft Loss

    Baseline to month 24

  • Incidence of Opportunistic infections

    Baseline to month 24

  • Incidence of BKV, CMV, and EBV Infection

    Baseline to month 24

  • Incidence of Treated Urinary Tract Infection

    Baseline to month 24

  • +7 more secondary outcomes

Eligibility Criteria

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

Adults undergoing kidney transplantation.

You may qualify if:

  • Subjects undergoing primary or subsequent deceased-donor or living donor kidney transplantation
  • Subject and/or parent guardian must be able to understand and provide informed consent
  • Female subjects of childbearing potential must have a negative pregnancy test within 6 weeks of study entry.

You may not qualify if:

  • Need for combined organ transplantation with an extra-renal organ and/or islet
  • Recipient of previous non-renal solid organ and/or islet cell transplantation
  • Infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol
  • Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Mayo Clinic, Division of Nephrology

Phoenix, Arizona, 85054, United States

Location

The Scripps Research Institute, Scripps Center for Organ and Cell Transplantation,

La Jolla, California, 92037, United States

Location

Northwestern University, Feinberg School of Medicine, Division of Organ Transplantation

Chicago, Illinois, 60611, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Medical University of South Carolina, Division of Transplant

Charleston, South Carolina, 29425, United States

Location

Related Publications (6)

  • Kurian SM, Heilman R, Mondala TS, Nakorchevsky A, Hewel JA, Campbell D, Robison EH, Wang L, Lin W, Gaber L, Solez K, Shidban H, Mendez R, Schaffer RL, Fisher JS, Flechner SM, Head SR, Horvath S, Yates JR, Marsh CL, Salomon DR. Biomarkers for early and late stage chronic allograft nephropathy by proteogenomic profiling of peripheral blood. PLoS One. 2009 Jul 10;4(7):e6212. doi: 10.1371/journal.pone.0006212.

    PMID: 19593431BACKGROUND

  • Brouard S, Mansfield E, Braud C, Li L, Giral M, Hsieh SC, Baeten D, Zhang M, Ashton-Chess J, Braudeau C, Hsieh F, Dupont A, Pallier A, Moreau A, Louis S, Ruiz C, Salvatierra O, Soulillou JP, Sarwal M. Identification of a peripheral blood transcriptional biomarker panel associated with operational renal allograft tolerance. Proc Natl Acad Sci U S A. 2007 Sep 25;104(39):15448-53. doi: 10.1073/pnas.0705834104. Epub 2007 Sep 14.

    PMID: 17873064BACKGROUND

  • Mas VR, Mas LA, Archer KJ, Yanek K, King AL, Gibney EM, Cotterell A, Fisher RA, Posner M, Maluf DG. Evaluation of gene panel mRNAs in urine samples of kidney transplant recipients as a non-invasive tool of graft function. Mol Med. 2007 May-Jun;13(5-6):315-24. doi: 10.2119/2007-00017.Mas.

    PMID: 17622313BACKGROUND

  • Muthukumar T, Dadhania D, Ding R, Snopkowski C, Naqvi R, Lee JB, Hartono C, Li B, Sharma VK, Seshan SV, Kapur S, Hancock WW, Schwartz JE, Suthanthiran M. Messenger RNA for FOXP3 in the urine of renal-allograft recipients. N Engl J Med. 2005 Dec 1;353(22):2342-51. doi: 10.1056/NEJMoa051907.

    PMID: 16319383BACKGROUND

  • Veronese F, Rotman S, Smith RN, Pelle TD, Farrell ML, Kawai T, Benedict Cosimi A, Colvin RB. Pathological and clinical correlates of FOXP3+ cells in renal allografts during acute rejection. Am J Transplant. 2007 Apr;7(4):914-22. doi: 10.1111/j.1600-6143.2006.01704.x. Epub 2007 Feb 7.

    PMID: 17286616BACKGROUND

  • Kurian SM, Williams AN, Gelbart T, Campbell D, Mondala TS, Head SR, Horvath S, Gaber L, Thompson R, Whisenant T, Lin W, Langfelder P, Robison EH, Schaffer RL, Fisher JS, Friedewald J, Flechner SM, Chan LK, Wiseman AC, Shidban H, Mendez R, Heilman R, Abecassis MM, Marsh CL, Salomon DR. Molecular classifiers for acute kidney transplant rejection in peripheral blood by whole genome gene expression profiling. Am J Transplant. 2014 May;14(5):1164-72. doi: 10.1111/ajt.12671. Epub 2014 Apr 11.

    PMID: 24725967RESULT

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Samples of blood, urine, and tissue

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Abecassis, MD, MBA

    Northwestern University

    PRINCIPAL INVESTIGATOR

  • John J Friedewald, MD

    Northwestern University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2011

First Posted

February 4, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 14, 2017

Record last verified: 2017-08

Locations

US(5)