Serial Blood and Urine Monitoring Study in Kidney Transplant Recipients (PROGENI-KI)
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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 |
- 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 ]
- 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
| Estimated Enrollment: | 300 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
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 |
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 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| Contact: Merideth Brown, MS | 301-435-7569 | brownmeri@niaid.nih.gov |
| United States, Arizona | |
| Mayo Clinic, Division of Nephrology | Recruiting |
| Phoenix, Arizona, United States, 85054 | |
| Contact: Raymond Heilman, MD Heilman.raymond@mayo.edu | |
| Contact: Michael Leonard leonard.michael@mayo.edu | |
| Principal Investigator: Raymond Heilman, MD | |
| United States, California | |
| The Scripps Research Institute, Scripps Center for Organ and Cell Transplantation, | Recruiting |
| La Jolla, California, United States, 92037 | |
| Contact: Shannon Cyhan cyhan.shannon@scrippshealth.org | |
| Contact: Christopher Marsh, MD marsh.christopher@scrippshealth.org | |
| Principal Investigator: Christopher Marsh, MD | |
| United States, Illinois | |
| Northwestern University, Feinberg School of Medicine, Division of Organ Transplantation | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: jane charette jane-charette@northwestern.edu | |
| Contact: John J Friedewald, MD jfriedewald@northwestern.edu | |
| Principal Investigator: John J Friedewald, MD | |
| United States, Ohio | |
| The Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Emilio Poggio, MD poggioe@ccf.edu | |
| Contact: Jennifer Czerr czerrj@ccf.org | |
| Principal Investigator: Emilio Poggio, MD | |
| United States, South Carolina | |
| Medical University of South Carolina, Division of Transplant | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Gail Johnson cronan@musc.edu | |
| Principal Investigator: Prabhakar Baliga, MD | |
| 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: | October 9, 2012 |
| 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 May 19, 2013