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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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New Enrollment Study


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General
Study Status Progress Inadequate
Application Number /
Requirement Number
H130001 / PAS001
Date Original Protocol Accepted 08/24/2015
Date Current Protocol Accepted 08/24/2015
Study Name New Enrollment Study
Device Name KANEKA LIXELLE BETA 2-MICROGLOBULIN APHERESIS COLUMN
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Neonate: 1-28 days, Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives The primary objective of the study is to assess the safety of Lixelle column in patients with (dialysis-related amyloidosis) DRA in the US. The secondary objective of the study is to assess the probable benefit of Lixelle column to increase the 2M reduction rate in a single dialysis session.

This is a new enrollment study. This is a prospective study with two arms; DRA patients treated with Lixelle column (treatment arm) and DRA patients treated with conventional hemodialysis(HD) (natural history arm). The PAS will consist of four stages for the two groups. Stages 1, 3 and 4 will be observed in the natural history arm and Stages 1, 2, 3 and 4 will be observed in the study arm.
Study Population Patients receiving thrice-weekly HD (conventional hemodialysis) and diagnosed as DRA by one or more of the following 2-1 to 2-4 will be included:
2-1. Biopsy of any tissue, showing Congo-red positive amyloid fibrils and immunohistochemical stains consistent with ß2M
2-2. Shoulder ultrasonography showing rotator cuffs greater than 8 mm in thickness, and/or echogenic pads between muscle groups of the rotator cuff
2-3. Two or more diagnoses of the following (1) to (5)
(1) Polyarthralgia
(2) Carpal tunnel syndrome
(3) Trigger finger
(4) Dialysis-associated spondylosis ((i) or (ii))
(i) Destructive spondyloarthropathy (DSA)
(ii) Spinal stenosis
(5) Bone cysts (Bone cysts considered to be caused by other diseases such as osteoarthritis, aneurysmal bone cysts and unicameral bone cysts should be excluded.)
2-4. Biopsy of any tissue, showing Congo-red positive amyloid fibrils, and one diagnosis or surgical history of criterion specified above in 2-3 (1) to (5)
Sample Size 30 DRA patients treated with Lixelle column (study arm) and 10 DRA patients treated with conventional HD. The sample size is based on clinical considerations and is not statistically driven.
Key Study Endpoints Primary endpoint
The primary endpoint is the rate of every SAE in the through 2 years of Lixelle treatment during the study period. The data will be assessed by descriptive statistics and will be compared to the SAE rate observed in the natural history arm.

Secondary endpoints
There are three secondary endpoints to assess the probable benefit of Lixelle in serum 2M reduction rate in a single Lixelle-treatment:
1. In study arm, 2M reduction rates obtained in Stage 2 (2nd week to 7th week) will be statistically compared with that in Stage 1 (1st week).
2. In study arm, 2M reduction rates obtained in Stage 3 (any week from 46th to 53rd week) will be statistically compared with that in Stage 1.
3. Differences in 2M reduction rates will be statistically compared between Stage 1 and Stage 3 in the natural history arm and study arm respectively.
Follow-up Visits and Length of Follow-up Patients will be followed for 2 years

The follow-up assessments for both groups are as follows: Stages 1 (1st week), 3 (any week from 45th to 52nd week) and 4 (any week from 93rd to 104th week) will be observed in the natural history arm and Stages 1 (1st week), 2 (2nd week to 7th week), 3 (any week from 46th to 53rd week) and 4 (any week from 94th to 105th week) will be observed in the study arm.


New Enrollment Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/03/2015 08/31/2015 On Time
1 year report 03/04/2016 02/25/2016 On Time
18 month report 09/02/2016 08/25/2016 On Time
2 year report 03/04/2017 02/21/2017 On Time
3 year report 03/04/2018 03/01/2018 On Time
4 year report 03/04/2019 03/01/2019 On Time
5 year report 03/04/2020 03/02/2020 On Time
6 year report 03/04/2021 03/03/2021 On Time
7 year report 03/04/2022 03/02/2022 On Time
8 year report 03/04/2023    
9 year report 03/04/2024    
10 year report 03/04/2025    
Final Report 06/30/2026    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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