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Kidney TransplantPROGENI-KINCT01289717

Proteogenomic Biomarker Panels in a Serial Blood & Urine Monitoring Study of Kidney Transplant Recipients

An observational study of Kidney Transplant and Kidney Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Transplant, Kidney Transplantation
How many people
307 participants
Where
5 sitesUnited States
Study dates
Mar 2011to Jun 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults undergoing kidney transplantation.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Medical University of South Carolina, Division of Transplant

    Charleston, South Carolina, 29425

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

    Chicago, Illinois, 60611

  • The Cleveland Clinic

    Cleveland, Ohio, 44195

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

    La Jolla, California, 92037

  • Mayo Clinic, Division of Nephrology

    Phoenix, Arizona, 85054

Other trials in United States

About this study

Official title: Discovery and Validation of Proteogenomic Biomarker Panels in a Prospective Serial Blood & Urine Monitoring Study of Kidney Transplant Recipients - Transplant Proteogenomics

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.

Read the 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).

Keywords
biomarkers, proteogenomic profiling, acute rejection, chronic allograft nephropathy/interstitial fibrosis and tubular atrophy
Medical subject headings
Pulmonary Fibrosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 and 24 months

Secondary outcomes (12)

  1. Incidence of Death

    Measured: Baseline to month 24

  2. Incidence of Graft Loss

    Measured: Baseline to month 24

  3. Incidence of Opportunistic infections

    Measured: Baseline to month 24

  4. Incidence of BKV, CMV, and EBV Infection

    Measured: Baseline to month 24

  5. Incidence of Treated Urinary Tract Infection

    Measured: Baseline to month 24

  6. Incidence of Malignancy

    Measured: Baseline to month 24

  7. Changes that Occur in Blood, Urine, and Kidney Tissue Gene Expression Signature

    Measured: Month 1 to month 24

  8. Changes in Plasma Protein Expression Profile

    Measured: Month 1 to month 24

  9. Changes in Urine Protein Expression Profile

    Measured: Month 1 to month 24

  10. Changes in Blood MicroRNA Expression Profile

    Measured: Month 1 to month 24

  11. Evolution of Gene and Protein Expression Profiles During Response to Therapy for AR

    Measured: Month 1 to month 24

  12. Evolution of Gene and Protein Expression Profiles During Progression or Regression of CAN/IFTA on Protocol Biopsies

    Measured: Month 1 to month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
307 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01289717
Sponsor's protocol ID
DAIT CTOT-08
Acronym
PROGENI-KI
Status last verified
Sep 2026
First submitted
2 Feb 2011
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19593431

  • 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.

    PubMed 17873064

  • 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.

    PubMed 17622313

  • 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.

    PubMed 16319383

  • 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.

    PubMed 17286616

  • 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.

    PubMed 24725967

  • Singla A, Park S, Pedamallu H, Chen K, Robelly B, Rebello C, Lantz C, Zhao L, LaCombe R, Sinha R, Hanna G, Kleiboeker S, Mehrotra S, Friedewald J. Diagnostic Performance and Resource Utilization of Combining Blood Gene Expression, Cell-Free DNA, and Urine Chemokines for Monitoring Kidney Rejection. Clin J Am Soc Nephrol. 2026 Aug 1;21(8):1414-1428. doi: 10.2215/CJN.0000001075. Epub 2026 May 21.

    PubMed 42166233

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Transplant and Kidney Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01289717, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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