Serial Blood and Urine Monitoring Study in Kidney Transplant Recipients (PROGENI-KI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01289717
First received: February 2, 2011
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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
Kidney Transplantation

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • The incidence of biopsy proven acute rejection (AR) (both 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of Death [ Time Frame: Baseline to month 24 ] [ Designated as safety issue: No ]
  • Incidence of Graft Loss [ Time Frame: Baseline to month 24 ] [ Designated as safety issue: No ]
  • Incidence of Opportunistic infections [ Time Frame: Baseline to month 24 ] [ Designated as safety issue: No ]
  • Incidence of BKV, CMV, and EBV infection [ Time Frame: Baseline to month 24 ] [ Designated as safety issue: No ]
  • Incidence of Treated urinary tract infection [ Time Frame: Baseline to month 24 ] [ Designated as safety issue: No ]
  • Incidence of Malignancy [ Time Frame: Baseline to month 24 ] [ Designated as safety issue: No ]
  • The changes that occur in blood, urine, and kidney tissue gene expression signature [ Time Frame: Month 1 to month 24 ] [ Designated as safety issue: No ]
  • The changes that occur in plasma protein expression profile [ Time Frame: Month 1 to month 24 ] [ Designated as safety issue: No ]
  • The changes that occur in urine protein expression profile [ Time Frame: Month 1 to month 24 ] [ Designated as safety issue: No ]
  • The Changes that occur in blood microRNA expression profile [ Time Frame: Month 1 to month 24 ] [ Designated as safety issue: No ]
  • The evolution of gene and protein expression profiles during response to therapy for AR [ Time Frame: Month 1 to month 24 ] [ Designated as safety issue: No ]
  • The evolution of gene and protein expression profiles during the progression or regression of CAN/IFTA on protocol biopsies [ Time Frame: Month 1 to month 24 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Samples of blood, urine, and tissue


Enrollment: 307
Study Start Date: March 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adults undergoing kidney transplantation.

Criteria

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 HCV or 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289717

Locations
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
Investigators
Principal Investigator: Michael Abecassis, MD, MBA Northwestern University
Study Chair: John J Friedewald, MD Northwestern University
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01289717     History of Changes
Other Study ID Numbers: DAIT CTOT-08
Study First Received: February 2, 2011
Last Updated: June 23, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Transplantation
Kidney
Biological Markers

ClinicalTrials.gov processed this record on July 24, 2014