Urine Testing to Detect Kidney Transplant Rejection

NCT00337220 | Completed DMC

• 1 other identifier: DAIT CTOT-04
• Study Type: observational
• Target: 492
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to determine if analysis of urine samples for specific markers can predict transplant rejection in people who have received kidney transplants.

Conditions

Kidney Transplantation; Kidney Disease; Kidney Failure, Chronic

Keywords

allograft; graft

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have recently undergone kidney transplant

You may qualify if:

• Scheduled to undergo primary or redo deceased- or living-donor kidney transplantation
• Ability to provide informed consent

You may not qualify if:

• Requires combined organ transplantation
• Previously received a solid organ transplant (other than kidney transplant) or islet cell transplant
• HCV infected
• HIV infected

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (5)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Cornell University

New York, New York, 10021, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (5)

• Dadhania D, Muthukumar T, Ding R, Li B, Hartono C, Serur D, Seshan SV, Sharma VK, Kapur S, Suthanthiran M. Molecular signatures of urinary cells distinguish acute rejection of renal allografts from urinary tract infection. Transplantation. 2003 May 27;75(10):1752-4. doi: 10.1097/01.TP.0000063931.08861.56.

  PMID: 12777869 BACKGROUND

• Ding R, Li B, Muthukumar T, Dadhania D, Medeiros M, Hartono C, Serur D, Seshan SV, Sharma VK, Kapur S, Suthanthiran M. CD103 mRNA levels in urinary cells predict acute rejection of renal allografts. Transplantation. 2003 Apr 27;75(8):1307-12. doi: 10.1097/01.TP.0000064210.92444.B5.

  PMID: 12717221 BACKGROUND

• Li B, Hartono C, Ding R, Sharma VK, Ramaswamy R, Qian B, Serur D, Mouradian J, Schwartz JE, Suthanthiran M. Noninvasive diagnosis of renal-allograft rejection by measurement of messenger RNA for perforin and granzyme B in urine. N Engl J Med. 2001 Mar 29;344(13):947-54. doi: 10.1056/NEJM200103293441301.

  PMID: 11274620 BACKGROUND

• Tatapudi RR, Muthukumar T, Dadhania D, Ding R, Li B, Sharma VK, Lozada-Pastorio E, Seetharamu N, Hartono C, Serur D, Seshan SV, Kapur S, Hancock WW, Suthanthiran M. Noninvasive detection of renal allograft inflammation by measurements of mRNA for IP-10 and CXCR3 in urine. Kidney Int. 2004 Jun;65(6):2390-7. doi: 10.1111/j.1523-1755.2004.00663.x.

  PMID: 15149352 BACKGROUND

• Suthanthiran M, Schwartz JE, Ding R, Abecassis M, Dadhania D, Samstein B, Knechtle SJ, Friedewald J, Becker YT, Sharma VK, Williams NM, Chang CS, Hoang C, Muthukumar T, August P, Keslar KS, Fairchild RL, Hricik DE, Heeger PS, Han L, Liu J, Riggs M, Ikle DN, Bridges ND, Shaked A; Clinical Trials in Organ Transplantation 04 (CTOT-04) Study Investigators. Urinary-cell mRNA profile and acute cellular rejection in kidney allografts. N Engl J Med. 2013 Jul 4;369(1):20-31. doi: 10.1056/NEJMoa1215555.

  PMID: 23822777 RESULT

Related Links

• Click here for the Clinical Trials in Organ Transplantation \[CTOT\] public Web site

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine collection

MeSH Terms

Conditions

Kidney Diseases; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Abraham Shaked, MD, PhD

  Department of Surgery, University of Pennsylvania Medical Center

  STUDY CHAIR

• John Friedewald, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Stuart Knechtle, MD

  Department of Surgery, University of Wisconsin

  PRINCIPAL INVESTIGATOR

• Jean Emond, MD

  Department of Surgery, Columbia University

  PRINCIPAL INVESTIGATOR

• Darshana Dadhania, MD

  Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 14, 2006
• First Posted: June 15, 2006
• Study Start: June 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 15, 2013

Record last verified: 2013-08

Locations

US (5)