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Plasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF) (NFD)

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ClinicalTrials.gov Identifier: NCT01078987
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : March 2, 2010
Last Update Posted : November 21, 2014
Sponsor:
Information provided by (Responsible Party):
Loma Linda University

Study Description
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Brief Summary:
The purpose of this study is to evaluate the pathophysiology of nephrogenic fibrosing dermopathy (NFD)/nephrogenic systemic fibrosis (NSF).

Condition or disease Intervention/treatment Phase
Nephrogenic Fibrosing Dermopathy Nephrogenic Systemic Fibrosis Procedure: Plasmapheresis Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Plasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF) and Understanding Its Etiology
Study Start Date : February 2002
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group 1
One to three 5-day course of plasma exchange (plasmapheresis)
 Procedure: Plasmapheresis
A course of 5 daily treatments of plasma exchange (plasmapheresis) for one to three courses
Active Comparator: Group 2
One to three 5-day course of plasma exchange (plasmapheresis)
 Procedure: Plasmapheresis
A course of 5 daily treatments of plasma exchange (plasmapheresis) for one to three courses
No Intervention: Group 3
No intervention taken
Active Comparator: Group 4
One to three 5-day course of plasma exchange (plasmapheresis)
 Procedure: Plasmapheresis
A course of 5 daily treatments of plasma exchange (plasmapheresis) for one to three courses


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078987


Locations
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United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Pedro Baron, MD Loma Linda University Medical Center
More Information
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Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT01078987    
Other Study ID Numbers: 51018
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: November 2014
Keywords provided by Loma Linda University:
Nephrogenic Fibrosing Dermopathy (NFD)
Nephrogenic Systemic Fibrosis (NSF)
Additional relevant MeSH terms:
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Nephrogenic Fibrosing Dermopathy
Skin Diseases
Fibrosis
Pathologic Processes