NCT01078987

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2010

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 2, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

November 21, 2014

Status Verified

November 1, 2014

Enrollment Period

10.1 years

First QC Date

February 5, 2010

Last Update Submit

November 19, 2014

Conditions

Nephrogenic Fibrosing DermopathyNephrogenic Systemic Fibrosis

Keywords

Nephrogenic Fibrosing Dermopathy (NFD)Nephrogenic Systemic Fibrosis (NSF)

Outcome Measures

Primary Outcomes (1)

  • Improve elasticity of skin, including increased range of motion of compromised joints due to leathery skin

    Assessed two weeks after each monthly course of plasmapheresis

Study Arms (4)

Group 1

ACTIVE COMPARATOR

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

Procedure: Plasmapheresis

Group 2

ACTIVE COMPARATOR

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

Procedure: Plasmapheresis

Group 3

NO INTERVENTION

No intervention taken

Group 4

ACTIVE COMPARATOR

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

Procedure: Plasmapheresis

Interventions

PlasmapheresisPROCEDURE

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

Group 1Group 2Group 4

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Nephrogenic Fibrosing Dermopathy

Interventions

Plasmapheresis

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Component RemovalTherapeuticsSorption DetoxificationExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Pedro Baron, MD

    Loma Linda University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2010

First Posted

March 2, 2010

Study Start

February 1, 2002

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

November 21, 2014

Record last verified: 2014-11

Locations

US(1)