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Proteogenomic Biomarker Panels in a Serial Blood & Urine Monitoring Study of Kidney Transplant Recipients (PROGENI-KI)

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ClinicalTrials.gov Identifier: NCT01289717
Recruitment Status : Completed
First Posted : February 4, 2011
Last Update Posted : August 14, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Kidney Transplant Kidney Transplantation

Detailed Description:

Kidney transplantation is a good treatment option for people with kidney disease. However, there is still much to learn about how to best care for the transplanted kidney and keep it working for a long time. One field of interest is how one's cellular make-up might affect the body's immune response (body's natural defense system to illness and foreign things) to a kidney transplant. Cellular tests, like gene expression, help doctors to study a person's cellular traits. Gene expression is when information found in one's DNA is translated into RNA and eventually proteins. These components are present in each of the body's cells. In this study, researchers are trying to learn if certain changes in the RNA and proteins found in blood, urine, or transplant biopsy tissue can detect rejection before injury can occur or become too severe. The blood and urine tests will look for patterns in one's DNA (called genetic markers).

This study will follow subjects for 2 years after transplant. There will be a total of 12 study visits with additional study visits if rejection occurs. The study requires additional samples of blood, urine, and tissue to be collected during routine clinical visits and biopsies (a procedure to remove and examine a small piece of kidney tissue).

Study Design

Study Type : Observational
Actual Enrollment : 307 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Discovery and Validation of Proteogenomic Biomarker Panels in a Prospective Serial Blood & Urine Monitoring Study of Kidney Transplant Recipients - Transplant Proteogenomics
Study Start Date : March 2011
Primary Completion Date : June 2016
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  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 [ Time Frame: 12 and 24 months ]

Secondary Outcome Measures :
  1. Incidence of Death [ Time Frame: Baseline to month 24 ]
  2. Incidence of Graft Loss [ Time Frame: Baseline to month 24 ]
  3. Incidence of Opportunistic infections [ Time Frame: Baseline to month 24 ]
  4. Incidence of BKV, CMV, and EBV Infection [ Time Frame: Baseline to month 24 ]
  5. Incidence of Treated Urinary Tract Infection [ Time Frame: Baseline to month 24 ]
  6. Incidence of Malignancy [ Time Frame: Baseline to month 24 ]
  7. Changes that Occur in Blood, Urine, and Kidney Tissue Gene Expression Signature [ Time Frame: Month 1 to month 24 ]
  8. Changes in Plasma Protein Expression Profile [ Time Frame: Month 1 to month 24 ]
  9. Changes in Urine Protein Expression Profile [ Time Frame: Month 1 to month 24 ]
  10. Changes in Blood MicroRNA Expression Profile [ Time Frame: Month 1 to month 24 ]
  11. Evolution of Gene and Protein Expression Profiles During Response to Therapy for AR [ Time Frame: Month 1 to month 24 ]
  12. Evolution of Gene and Protein Expression Profiles During Progression or Regression of CAN/IFTA on Protocol Biopsies [ Time Frame: Month 1 to month 24 ]

Biospecimen Retention:   Samples With DNA
Samples of blood, urine, and tissue

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults undergoing kidney transplantation.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01289717

United States, Arizona
Mayo Clinic, Division of Nephrology
Phoenix, Arizona, United States, 85054
United States, California
The Scripps Research Institute, Scripps Center for Organ and Cell Transplantation,
La Jolla, California, United States, 92037
United States, Illinois
Northwestern University, Feinberg School of Medicine, Division of Organ Transplantation
Chicago, Illinois, United States, 60611
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, South Carolina
Medical University of South Carolina, Division of Transplant
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Clinical Trials in Organ Transplantation
Principal Investigator: Michael Abecassis, MD, MBA Northwestern University
Study Chair: John J Friedewald, MD Northwestern University
More Information

Additional Information:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01289717     History of Changes
Other Study ID Numbers: DAIT CTOT-08
First Posted: February 4, 2011    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
proteogenomic profiling
acute rejection
chronic allograft nephropathy/interstitial fibrosis and tubular atrophy