Immune Development in Pediatric Transplantation (IMPACT)

NCT00951353 | Completed DMC

• 1 other identifier: DAIT CTOTC-02
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 3

Brief Summary

Transplantation is the preferred method of treatment for end-stage renal disease (ESRD) in children. Over the past forty years, the use of newer immunosuppressive drugs has decreased the risk for organ rejection considerably, and improved short-term outcomes. However, these costly and complicated life-long treatment regimens also cause serious side effects. This has been particularly true for children, who undergo treatment with these drugs at the same time they are transitioning, physically and emotionally, from childhood to adulthood. These factors lead to significantly reduced life-spans, decreased drug regimen adherence, and an increased need for re-transplantation, as compared with adults. Current immunosuppressive procedures and strategies for children mimic those for adults, despite the difference between the two populations' immune systems and needs. New strategies aimed at tailoring to an individual child's needs would both reduce the risk of complications and improve outcomes. The purpose of this study is to generate information which will help to change the current practice of pediatric transplantation into one that is more individualized and preventative.

Conditions

Chronic Kidney Failure; End Stage Renal Disease

Keywords

Transplantation; Kidney Failure; End Stage Renal Disease; Pediatric

Outcome Measures

Primary Outcomes (1)

• Incidence of biopsy proven and treated (steroid pulse, taper, immunosuppressant medication changes) acute rejection Banff grade borderline or higher

  6 months after transplant

Secondary Outcomes (12)

• Incidence of treated, clinically suspected rejection without biopsy

  Throughout study

• Incidence of biopsy proven and clinically relevant chronic allograft nephropathy

  Throughout study

• Incidence of infection and malignancy

  Throughout study

• Incidence of medication non-adherence in pediatric kidney transplant recipients using self report questionnaires and electronic monitoring bottle caps

  Throughout study

• Clinical impact of medication non-adherence with regard to the incidence of acute and chronic rejection

  Throughout study

Study Arms (1)

Pediatric Renal Transplant Recipients

Eligibility Criteria

• Age: 1 Year - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric end-stage renal disease patients needing a kidney transplant

You may qualify if:

• Parent or legal guardian willing to provide informed consent, if necessary
• to 20 years of age (before 21st birthday) at the time of enrollment
• Undergoing renal transplantation

You may not qualify if:

• Need for multi-organ transplantation
• Any prior history of organ transplantation
• Inability or unwillingness of participant of their legal guardian to give written informed consent or comply with study protocol

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (3)

University of California at Los Angeles/ Mattel Children's Hospital

Los Angeles, California, United States

Location

Stanford University Medical Center/ Lucille Packard Children's Hospital

Palo Alto, California, United States

Location

Emory University/ Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Location

Related Publications (1)

• Ettenger R, Chin H, Kesler K, Bridges N, Grimm P, Reed EF, Sarwal M, Sibley R, Tsai E, Warshaw B, Kirk AD. Relationship Among Viremia/Viral Infection, Alloimmunity, and Nutritional Parameters in the First Year After Pediatric Kidney Transplantation. Am J Transplant. 2017 Jun;17(6):1549-1562. doi: 10.1111/ajt.14169. Epub 2017 Feb 1.

  PMID: 27989013 RESULT

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID) website
• Clinical Trials in Organ Transplantation in Children (CTOT-C) program website

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Allan D. Kirk, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2009
• First Posted: August 4, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: March 1, 2013
• Last Updated: January 3, 2019

Record last verified: 2018-12

Locations

US (3)