DBS for Home Monitoring in Children With Kidney Transplantation

NCT01931397 | Completed Results

• 1 other identifier: PROG-12G03
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Kidney transplantation is the treatment of choice for kidney failure in children. Kidney transplant recipients need to take immunosuppression for the rest of their lives after transplantation to prevent rejection of the graft. One of the important medications is called Tacrolimus which can prevent rejection of the kidney graft but at the same time is toxic to the kidney. Therefore, repeated blood levels of Tacrolimus with tests of kidney function will help physicians to prescribe the best dose for therapy to prevent kidney rejection and kidney toxicity. Failure of compliance with taking Tacrolimus is also an important cause of graft failure especially among teenagers, so repeated blood Tacrolimus levels are necessary to detect patients who fail to take their medications on a regular basis. We have developed a lab assay that measures Tacrolimus blood level and creatinine (for kidney function) using one dried blood spot (DBS) on filter paper similar to the filter paper used in the new born screen. We plan to teach patients how to do the test at home once a month and mail the filter paper back to OHSU for analysis for Tacrolimus and creatinine. The advantage of this method is that it is less painful for children then a regular blood dray from the vein, can be done easily at home, will be most cost effective as it will save the family a day of work or school and can detect both the Tacrolimus level and the kidney function at the same time. We will assess the effect of doing this simple finger prick at home on compliance, on Tacrolimus levels and kidney function over the study period of one year. We will also assess how satisfied patients are with this method instead of going to the lab or the hospital for blood test. All subjects will continue on their regular clinic visits and will continue to have their routine blood draws by intravenous method in the lab during the study.

Conditions

Kidney Disease

Keywords

Dried blood spots; kidney transplant; Children

Outcome Measures

Primary Outcomes (1)

• Variability of Tacrolimus Blood Levels Measured by DBS Over Time

  Mean standard deviation scores for Tacrolimus blood levels obtained by DBS for each patient over time.

  12 months

Secondary Outcomes (1)

• Percentage of Families Preferring DBS Method

  At baseline and then at 12 months

Other Outcomes (2)

• Mean Tacrolimus Blood Levels Measured by DBS Over Study Period According to Age

  up to 12 months

• Changes in Adherence Parameters to Home DBS Method

  At baseline then every 3 months for 12 months

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

children who are followed at the Pediatric Kidney Transplant CLinic at OHSU.

You may qualify if:

• Kidney transplant recipients between the ages of 2-21 years at time of enrollment
• On Tacrolimus immunosuppression therapy
• At least six months post kidney transplantation

You may not qualify if:

• Not on tacrolimus therapy Less than 6 months after kidney transplantation Refusal to provide consent fomr

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

Doernbecher Children's Hospital /OHSU

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

This is a pilot study to assess the feasibility of doing home dried blood spot sampling.

Results Point of Contact

• Title: Dr. Amira Al-Uzri , Professor of Pediatrics
• Organization: Oregon Health & Science University

aluzria@ohsu.edu

503-494-6956

Study Officials

• Amira Al-Uzri, MD, MCR

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: August 16, 2013
• First Posted: August 29, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 17, 2017
• Results First Posted: March 17, 2017

Record last verified: 2017-03

Locations

US (1)