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

November 19, 2014 updated by: Loma Linda University

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Assessed two weeks after each monthly course of plasmapheresis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Pedro Baron, MD, Loma Linda University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

February 5, 2010

First Submitted That Met QC Criteria

March 1, 2010

First Posted (Estimate)

March 2, 2010

Study Record Updates

Last Update Posted (Estimate)

November 21, 2014

Last Update Submitted That Met QC Criteria

November 19, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 51018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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