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CTOT-C

Improving outcomes for pediatric transplant recipients

The Clinical Trials in Organ Transplantation in Children (CTOT-C) project is a cooperative research program sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), with co-funding from the National Heart, Lung and Blood Institute (NHLBI). CTOT-C is an investigative consortium for conducting multi-institutional clinical and associated mechanistic studies that will lead to improved outcomes for pediatric transplant recipients. The purpose of these studies is to improve short and long-term graft and patient survival in children who have undergone heart, lung or kidney transplantation.

Visit the CTOT-C website for more information.

As the Statistical and Clinical Coordinating Center (SACCC) for the CTOT program, Rho’s responsibilities encompass a broad range of functions for the clinical trials and mechanistic studies, which include:

  • statistical design and analysis,
  • computer-based data collection and management,
  • database storage and management,
  • quality control,
  • reporting and associated training for clinical site personnel,
  • safety oversight and reporting of serious adverse events (SAEs),
  • regulatory guidance and support for investigational new drugs (INDs),
  • clinical site monitoring,
  • operational support,
  • management of study drug supply to sites,
  • preparation of study-related materials, and
  • website development and maintenance.

Project team members coordinate activities to support the design and conduct of a series of clinical, mechanistic, and biomarker studies. Rho statisticians provide leadership for the design and analysis of clinical trials and studies of underlying mechanisms. They also collaborate with clinicians during concept development, providing statistical and clinical trial expertise essential to creating the protocol. The administrative and infrastructure support tools established for this project include:

  • EDC and randomization systems,
  • specimen tracking systems,
  • a secure website,
  • standard operating procedures, and
  • document templates.

David Iklé (Ph.D., Senior Statistical Scientist) is the Principal Investigator (PI) for this coordinating center.

 

Protocol

Title

CTOTC-01

Immunosuppression Minimization to Single Drug Therapy with Sirolimus (Rapamune®) in Pediatric Transplantation

CTOTC-02

Immune Development in Pediatric Transplantation

CTOTC-03

Viral Triggers of Alloimmunity and Autoimmunity in Pediatric Lung Transplantation

CTOTC-04

Alloantibodies in Pediatric Heart Transplantation

CTOTC-05

Perceived Barriers to Patient Adherence after Pediatric Solid Organ Transplantation

CTOTC-06

Biomarkers for Post Transplant Lymphoproliferative Disorders in Children

CTOTC-08

B-cell Targeted Induction to Improve Outcomes in Pediatric Lung Transplantation

CTOTC-09

An Observational Cohort Study to Determine the Impact of Alloantibodies and Antibodies to Self Antigens on Chronic Graft Function up to 5 Years After Pediatric Heart Transplant

 

Studies in Development

Protocol        

Title

CTOTC-07

Polyclonal Tregs to Promote Tolerance in Pediatric Liver Transplant Recipients

CTOTC-10

Randomized Controlled Trial of Novel Mobile Device Application to Improve Adherence in Children >11 Years of Age After Cardiac Transplantation

CTOT-11

Prevalence and Correlates of PTSS in Adolescent Solid Organ Transplant Recipients

CTOTC-12

Safety of Donor Alloantigen Reactive Tregs to Facilitate Minimization and/or Discontinuation of Immunosuppression in Adult Liver Transplant Recipients