NCT01078987TerminatedPhase 4
Use of Plasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF) and Understanding Its Etiology
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Loma Linda University
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Improve elasticity of skin, including increased range of motion of compromised joints due to leathery skin
Study Overview
Brief Summary
The purpose of this study is to evaluate the pathophysiology of nephrogenic fibrosing dermopathy (NFD)/nephrogenic systemic fibrosis (NSF).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Exclusion Criteria
- Not provided
Arms & Interventions
Group 1
Active Comparator
One to three 5-day course of plasma exchange (plasmapheresis)
Intervention: Plasmapheresis (Procedure)
Group 2
Active Comparator
One to three 5-day course of plasma exchange (plasmapheresis)
Intervention: Plasmapheresis (Procedure)
Group 3
No Intervention
No intervention taken
Group 4
Active Comparator
One to three 5-day course of plasma exchange (plasmapheresis)
Intervention: Plasmapheresis (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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