Back to resultsPlasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF) (NFD)
Primary Purpose
Nephrogenic Fibrosing Dermopathy, Nephrogenic Systemic Fibrosis
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Plasmapheresis
Sponsored by
About this trial
This is an interventional treatment trial for Nephrogenic Fibrosing Dermopathy focused on measuring Nephrogenic Fibrosing Dermopathy (NFD), Nephrogenic Systemic Fibrosis (NSF)
Eligibility Criteria
Inclusion Criteria:
- diagnosed with NFD/NSF following a kidney transplant
- diagnosed with NFD/NSF following a liver transplant
- NFD/NSF and who have not had a kidney or liver transplant
- diagnosed with NFD/NSF and who have not had a kidney or liver transplant
Sites / Locations
- Loma Linda University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
No Intervention
Active Comparator
Arm Label
Group 1
Group 2
Group 3
Group 4
Arm Description
One to three 5-day course of plasma exchange (plasmapheresis)
One to three 5-day course of plasma exchange (plasmapheresis)
No intervention taken
One to three 5-day course of plasma exchange (plasmapheresis)
Outcomes
Primary Outcome Measures
Improve elasticity of skin, including increased range of motion of compromised joints due to leathery skin
Secondary Outcome Measures
Full Information
NCT ID
NCT01078987
First Posted
February 5, 2010
Last Updated
November 19, 2014
Sponsor
Loma Linda University
1. Study Identification
Unique Protocol Identification Number
NCT01078987
Brief Title
Plasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF)
Acronym
NFD
Official Title
Use of Plasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF) and Understanding Its Etiology
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment
Study Start Date
February 2002 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the pathophysiology of nephrogenic fibrosing dermopathy (NFD)/nephrogenic systemic fibrosis (NSF).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrogenic Fibrosing Dermopathy, Nephrogenic Systemic Fibrosis
Keywords
Nephrogenic Fibrosing Dermopathy (NFD), Nephrogenic Systemic Fibrosis (NSF)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
One to three 5-day course of plasma exchange (plasmapheresis)
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
One to three 5-day course of plasma exchange (plasmapheresis)
Arm Title
Group 3
Arm Type
No Intervention
Arm Description
No intervention taken
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
One to three 5-day course of plasma exchange (plasmapheresis)
Intervention Type
Procedure
Intervention Name(s)
Plasmapheresis
Intervention Description
A course of 5 daily treatments of plasma exchange (plasmapheresis) for one to three courses
Primary Outcome Measure Information:
Title
Improve elasticity of skin, including increased range of motion of compromised joints due to leathery skin
Time Frame
Assessed two weeks after each monthly course of plasmapheresis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
diagnosed with NFD/NSF following a kidney transplant
diagnosed with NFD/NSF following a liver transplant
NFD/NSF and who have not had a kidney or liver transplant
diagnosed with NFD/NSF and who have not had a kidney or liver transplant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Baron, MD
Organizational Affiliation
Loma Linda University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Plasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF)
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