Clinical trial NCT00308802: Noninvasive Methods to Monitor Graft Survival in Kidney Transplant Patients
Official title: Noninvasive Monitoring to Predict Outcome in De Novo Kidney Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Keywords: Kidney
Transplant
Rejection
Kidney Disease
Kidney Failure
End Stage Renal Disease
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2006-03-30
Enrollment: 280
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who are candidates for kidney transplant

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.

Detailed description: Innovations in kidney transplantation have improved short-term outcomes for transplant patients. However, organ rejection remains as an important threat to the long-term survival of the transplanted organ. If clinicians could better monitor the condition of the organ after transplantation, they may be able to improve the chance of graft survival. Noninvasive ways to monitor the condition of the transplanted organ need to be developed and tested. This observational study will investigate whether certain blood and urine tests are useful in monitoring the health of transplanted kidneys.

This trial will involve 14 post-transplant study visits over the course of 2 years. A physical exam, medication history, adverse events assessment, and blood and urine collection will occur at all visits. Kidney biopsies will occur at study entry prior to transplantation and at Month 6, in adult participants only. Protocol biopsies are optional in the pediatric substudy group. Additional visits may be required if organ rejection is suspected.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Atlanta
country: United States
facility: Emory Children's Center
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Winnipeg
country: Canada
facility: Children's Hospital of Winnipeg
state: Manitoba
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Peter S. Heeger, MD
role: STUDY_DIRECTOR
affiliation: University Hospitals Cleveland Medical Center
name: Donald Hricik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba at Winnipeg
name: David Rush, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Kenneth Newell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Richard Formica, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Emilio Poggio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory-Children's Center
name: Barry Warshaw, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Enver Akalin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Winnipeg
name: Patricia Birk, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.