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

NCT ID: NCT01078987

Last Updated: 2014-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2012-03-31

Brief Summary

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

Detailed Description

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Conditions

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Nephrogenic Fibrosing Dermopathy Nephrogenic Systemic Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

One to three 5-day course of plasma exchange (plasmapheresis)

Group Type ACTIVE_COMPARATOR

Plasmapheresis

Intervention Type PROCEDURE

A course of 5 daily treatments of plasma exchange (plasmapheresis) for one to three courses

Group 2

One to three 5-day course of plasma exchange (plasmapheresis)

Group Type ACTIVE_COMPARATOR

Plasmapheresis

Intervention Type PROCEDURE

A course of 5 daily treatments of plasma exchange (plasmapheresis) for one to three courses

Group 3

No intervention taken

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 4

One to three 5-day course of plasma exchange (plasmapheresis)

Group Type ACTIVE_COMPARATOR

Plasmapheresis

Intervention Type PROCEDURE

A course of 5 daily treatments of plasma exchange (plasmapheresis) for one to three courses

Interventions

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Plasmapheresis

A course of 5 daily treatments of plasma exchange (plasmapheresis) for one to three courses

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pedro Baron, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University Medical Center

Locations

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Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Countries

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United States

Other Identifiers

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51018

Identifier Type: -

Identifier Source: org_study_id