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NCT Number: NCT01974999

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

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.

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Key information

Conditions

Kidney Disease Behavior Chronic Disease Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rejection, Psychology Renal Insufficiency Renal Insufficiency, Chronic Social Behavior Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Winnipeg, Winnipeg, Manitoba, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in estimated glomerular filtration Rate (eGFR) from 6 months to 5 years post-transplantation

    Time frame: Day 1

    Modification of Diet in Renal Disease (MDRD) in the adult cohort and Schwartz method in the pediatric cohort

Secondary outcomes

  1. Patient survival as assessed by the incidence of death reported in the first 5 years post- transplant

    Time frame: Day 1

  2. Graft survival as assessed by the incidence of graft loss reported in the first 5 years post- transplant

    Time frame: Day 1

  3. Renal function as assessed by the absolute glomerular filtration Rate (GFR) at 5 years post-transplant

    Time frame: Day 1

  4. Change in Chronic Kidney Disease stages between transplant and 5 years post- transplant

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • Clinical Trials in Organ Transplantation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 4, 2013
Registry last updated
Jan 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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