Noninvasive Methods to Monitor Graft Survival in Kidney Transplant Patients

NCT00308802 | Completed DMC

• 1 other identifier: DAIT CTOT-01
• Study Type: observational
• Target: 280
• Locations: 2 countries
• Sites: 9

Brief Summary

The purpose of this study is to test noninvasive methods to monitor the health and condition of new kidneys in people who have received kidney transplants.

Conditions

Kidney Transplantation

Keywords

Kidney; Transplant; Rejection; Kidney Disease; Kidney Failure; End Stage Renal Disease

Interventions

Kidney transplantation PROCEDURE

Participants in this study will have had a kidney transplant

Eligibility Criteria

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

Study Population

People who are candidates for kidney transplant

You may qualify if:

• Candidate for deceased donor or living donor kidney transplant
• Negative Crossmatch
• Parent or guardian willing to provide informed consent, if applicable

You may not qualify if:

• Clinically significant liver disease
• Other illnesses that, in the opinion of the investigator, may interfere with the study
• Recipient of multiple organ transplants
• Inability or unwillingness to comply with the study protocol

Sponsors & Collaborators

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

Study Sites (9)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Emory Children's Center

Atlanta, Georgia, 30322, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44195, United States

Location

Children's Hospital of Winnipeg

Winnipeg, Manitoba, R3A 151, Canada

Location

University of Manitoba

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Related Publications (4)

• Kaplan B, Srinivas TR, Meier-Kriesche HU. Factors associated with long-term renal allograft survival. Ther Drug Monit. 2002 Feb;24(1):36-9. doi: 10.1097/00007691-200202000-00007.

  PMID: 11805720 BACKGROUND

• Meier-Kriesche HU, Schold JD, Kaplan B. Long-term renal allograft survival: have we made significant progress or is it time to rethink our analytic and therapeutic strategies? Am J Transplant. 2004 Aug;4(8):1289-95. doi: 10.1111/j.1600-6143.2004.00515.x.

  PMID: 15268730 BACKGROUND

• Meier-Kriesche HU, Schold JD, Srinivas TR, Kaplan B. Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era. Am J Transplant. 2004 Mar;4(3):378-83. doi: 10.1111/j.1600-6143.2004.00332.x.

  PMID: 14961990 BACKGROUND

• Hricik DE, Nickerson P, Formica RN, Poggio ED, Rush D, Newell KA, Goebel J, Gibson IW, Fairchild RL, Riggs M, Spain K, Ikle D, Bridges ND, Heeger PS; CTOT-01 consortium. Multicenter validation of urinary CXCL9 as a risk-stratifying biomarker for kidney transplant injury. Am J Transplant. 2013 Oct;13(10):2634-44. doi: 10.1111/ajt.12426. Epub 2013 Aug 22.

  PMID: 23968332 RESULT

Related Links

• Click here for the Clinical Trials in Organ Transplantation (CTOT) public Web site

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples may be retained

MeSH Terms

Conditions

Rejection, Psychology; Kidney Diseases; Renal Insufficiency; Kidney Failure, Chronic

Interventions

Kidney Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Peter S. Heeger, MD

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

• Donald Hricik, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• David Rush, MD

  University of Manitoba at Winnipeg

  PRINCIPAL INVESTIGATOR

• Kenneth Newell, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Richard Formica, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Emilio Poggio, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Barry Warshaw, MD

  Emory-Children's Center

  PRINCIPAL INVESTIGATOR

• Enver Akalin, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Patricia Birk, M.D.

  Children's Hospital of Winnipeg

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 28, 2006
• First Posted: March 30, 2006
• Study Start: March 1, 2006
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 2, 2013

Record last verified: 2013-08

Locations

US (7); CA (2)