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

Loma Linda University (LLU)

Status and phase: Terminated; Phase 4

Conditions: Nephrogenic Systemic Fibrosis; Nephrogenic Fibrosing Dermopathy

Treatments: Procedure: Plasmapheresis

Study type: Interventional

Funder types: Other

Identifiers

NCT01078987

51018

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Group 1

Active Comparator group

Description:

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

Treatment:

Procedure: Plasmapheresis

Group 2

Active Comparator group

Description:

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

Treatment:

Procedure: Plasmapheresis

Group 3

No Intervention group

Description:

No intervention taken

Group 4

Active Comparator group

Description:

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

Treatment:

Procedure: Plasmapheresis