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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

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 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
U.S. FDA Resources

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



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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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

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
United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Pedro Baron, MD Loma Linda University Medical Center

Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT01078987     History of Changes
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:
Fibrosis
Nephrogenic Fibrosing Dermopathy
Skin Diseases
Pathologic Processes