Use of Plasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF) and Understanding Its Etiology

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Loma Linda University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Loma Linda University
ClinicalTrials.gov Identifier:
NCT01078987
First received: February 5, 2010
Last updated: June 1, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Nephrogenic Fibrosing Dermopathy
Nephrogenic Systemic Fibrosis
Procedure: Plasmapheresis
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Plasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF) and Understanding Its Etiology

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: February 2002
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • People who have been diagnosed with NFD/NSF following a kidney transplant
  • People who have been diagnosed with NFD/NSF following a liver transplant
  • People with no NFD/NSF and who have not had a kidney or liver transplant
  • People who have been diagnosed with NFD/NSF and who have not had a kidney or liver transplant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078987

Contacts
Contact: Pedro Baron, MD 909-558-3672 pbaron@llu.edu
Contact: Jacquie Limjoco, BA 909-558-3672 jlimjoco@llu.edu

Locations
United States, California
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Jacquie Limjoco       jlimjoco@llu.edu   
Principal Investigator: Pedro Baron, MD         
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Pedro Baron, MD Loma Linda University Medical Center
  More Information

No publications provided

Responsible Party: Pedro Baron, MD, Loma Linda University Medical Center
ClinicalTrials.gov Identifier: NCT01078987     History of Changes
Other Study ID Numbers: 51018
Study First Received: February 5, 2010
Last Updated: June 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
Nephrogenic Fibrosing Dermopathy (NFD)
Nephrogenic Systemic Fibrosis (NSF)

Additional relevant MeSH terms:
Fibrosis
Nephrogenic Fibrosing Dermopathy
Pathologic Processes
Skin Diseases

ClinicalTrials.gov processed this record on July 26, 2014