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

This study is currently recruiting participants.

Verified June 2011 by Loma Linda University

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

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

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 May 22, 2013