CompletedNCT00308802Updated Sep 25, 2026

Noninvasive Methods to Monitor Graft Survival in Kidney Transplant Patients

An observational study in Kidney Transplantation, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 9 sites in 2 countries. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 280
Sex: All

Study 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.

Read the 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.

Conditions studied

Kidney Transplantation

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Keywords

Kidney
Transplant
Rejection
Kidney Disease
Kidney Failure
End Stage Renal Disease

In context

Rejection, Psychology

50 studies on the registry are indexed under Rejection, Psychology; 27 are open to participants now.

This study's enrollment of 280 is above the median of 188 across 25 observational studies indexed under Rejection, Psychology.

Browse Rejection, Psychology studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

People who are candidates for kidney transplant

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

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

Study design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 280 participants (actual)
Biospecimen retention: Samples with dna

Interventions

ProcedureKidney transplantation
Participants in this study will have had a kidney transplant

Study locations

9 sites

Yale University School of Medicine
New Haven, Connecticut 06510, United States
Emory Children's Center
Atlanta, Georgia 30322, United States
Emory University Hospital
Atlanta, Georgia 30322, United States
Mount Sinai School of Medicine
New York, New York 10029, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229, United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195, United States
University Hospitals of Cleveland
Cleveland, Ohio 44195, United States
Children's Hospital of Winnipeg
Winnipeg, Manitoba R3A 151, Canada
University of Manitoba
Winnipeg, Manitoba R3A 1R9, Canada

References and documents

Publications

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. PubMed 11805720 ↗
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. PubMed 15268730 ↗
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. PubMed 14961990 ↗
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. PubMed 23968332 ↗

Updates

1 registry update since Sep 25, 2026

Minor edits

Nothing that changes what the study is or who can join. Edited: index terms, verification date, contact details, site details and references

1 update, last Sep 25, 2026

Show all 1 update

Sep 25, 2026
Minor edits only
+ 5 other changes: index terms, verification date, contact details, site details and references

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00308802
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party: Sponsor
First posted: Mar 30, 2006
Start date: Mar 2006
Primary completion: Jul 2011
Completion: Jul 2011
Last update: Sep 25, 2026

Study contacts

Peter S. Heeger, MD

study director · Icahn School of Medicine at Mount Sinai

Donald Hricik, MD

principal investigator · University Hospitals Cleveland Medical Center

David Rush, MD

principal investigator · University of Manitoba at Winnipeg

Kenneth Newell, MD

principal investigator · Emory University

Richard Formica, MD

principal investigator · Yale University

Emilio Poggio, MD

principal investigator · The Cleveland Clinic

Barry Warshaw, MD

principal investigator · Emory-Children's Center

Enver Akalin, MD

principal investigator · Icahn School of Medicine at Mount Sinai

Patricia Birk, M.D.

principal investigator · The Children's Hospital of Winnipeg

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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