A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study

End Stage Renal Disease Clinical Trial

Official title:

A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study (CTOT-17)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974999
• Other study ID #: DAIT CTOT-17
• Status: Completed
• Start date: October 2013
• Est. completion date: July 2014

Study information

• Verified date: December 2018
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a multicenter, non-randomized, retrospective study to collect long term (5 years post-transplant) clinical outcome data to test whether the results of the noninvasive immune monitoring test strategy performed in the parent study (CTOT-01, NCT00308802) in first six-month post-transplant is predictive of 5-year outcomes. Each center will complete a retrospective chart review for the data on patient survival, graft survival and renal function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participants previously enrolled in the CTOT-01 study.

• Participants who are at least 5 years post-transplant (+/- 6 months), no later than March 31, 2014.

Exclusion Criteria:

• Withdrawal of consent to continue in the CTOT-01 study.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Disease
• Kidney Diseases
• Kidney Failure
• Kidney Failure, Chronic
• Renal Insufficiency

Locations

Country	Name	City	State
Canada	Children's Hospital of Winnipeg	Winnipeg	Manitoba
Canada	University of Manitoba Health Sciences Centre	Winnipeg	Manitoba
United States	Emory University	Atlanta	Georgia
United States	Cleveland Clinic Foundation, Glickman Urological Institute	Cleveland	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Clinical Trials in Organ Transplantation

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Faddoul G, Nadkarni GN, Bridges ND, Goebel J, Hricik DE, Formica R, Menon MC, Morrison Y, Murphy B, Newell K, Nickerson P, Poggio ED, Rush D, Heeger PS; CTOT-17 consortium. Analysis of Biomarkers Within the Initial 2 Years Posttransplant and 5-Year Kidney — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in estimated glomerular filtration Rate (eGFR) from 6 months to 5 years post-transplantation	Modification of Diet in Renal Disease (MDRD) in the adult cohort and Schwartz method in the pediatric cohort	Day 1
Secondary	Patient survival as assessed by the incidence of death reported in the first 5 years post- transplant		Day 1
Secondary	Graft survival as assessed by the incidence of graft loss reported in the first 5 years post- transplant		Day 1
Secondary	Renal function as assessed by the absolute glomerular filtration Rate (GFR) at 5 years post-transplant		Day 1
Secondary	Change in Chronic Kidney Disease stages between transplant and 5 years post- transplant		Day 1

External Links

•   Clinical Trials in Organ Transplantation (CTOT)
•   Division of Allergy, Immunology, and Transplantation (DAIT)
•   National Institute of Allergy and Infectious Diseases (NIAID)