Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT00308802
Status:
COMPLETED
Last Update Posted:
2013-09-02
First Post:
2006-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Noninvasive Methods to Monitor Graft Survival in Kidney Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012059', 'term': 'Rejection, Psychology'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016030', 'term': 'Kidney Transplantation'}], 'ancestors': [{'id': 'D017582', 'term': 'Renal Replacement Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016377', 'term': 'Organ Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples may be retained'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-29', 'studyFirstSubmitDate': '2006-03-28', 'studyFirstSubmitQcDate': '2006-03-28', 'lastUpdatePostDateStruct': {'date': '2013-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Kidney', 'Transplant', 'Rejection', 'Kidney Disease', 'Kidney Failure', 'End Stage Renal Disease'], 'conditions': ['Kidney Transplantation']}, 'referencesModule': {'references': [{'pmid': '11805720', 'type': 'BACKGROUND', '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.'}, {'pmid': '15268730', 'type': 'BACKGROUND', '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.'}, {'pmid': '14961990', 'type': 'BACKGROUND', '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.'}, {'pmid': '23968332', 'type': 'RESULT', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.ctotstudies.org', 'label': 'Click here for the Clinical Trials in Organ Transplantation (CTOT) public Web site'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People who are candidates for kidney transplant', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Candidate for deceased donor or living donor kidney transplant\n* Negative Crossmatch\n* Parent or guardian willing to provide informed consent, if applicable\n\nExclusion Criteria:\n\n* Clinically significant liver disease\n* Other illnesses that, in the opinion of the investigator, may interfere with the study\n* Recipient of multiple organ transplants\n* Inability or unwillingness to comply with the study protocol'}, 'identificationModule': {'nctId': 'NCT00308802', 'briefTitle': 'Noninvasive Methods to Monitor Graft Survival in Kidney Transplant Patients', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Noninvasive Monitoring to Predict Outcome in De Novo Kidney Transplant Recipients', 'orgStudyIdInfo': {'id': 'DAIT CTOT-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Kidney transplantation', 'type': 'PROCEDURE', 'description': 'Participants in this study will have had a kidney transplant'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Emory Children's Center", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals of Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': 'R3A 151', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': "Children's Hospital of Winnipeg", 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'R3A 1R9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'Peter S. Heeger, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}, {'name': 'Donald Hricik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}, {'name': 'David Rush, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba at Winnipeg'}, {'name': 'Kenneth Newell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}, {'name': 'Richard Formica, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}, {'name': 'Emilio Poggio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}, {'name': 'Barry Warshaw, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Emory-Children's Center"}, {'name': 'Enver Akalin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}, {'name': 'Patricia Birk, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Winnipeg"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}