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NCT01014754 · ClinicalTrials.gov registry record

Nephrogenic Systemic Fibrosis (NSF): Analysis of Tissue Gadolinium Levels

A clinical trial, sponsored by Northwestern University.

Completed
Registry status
24
Enrollment target

NCT01014754: Completed study, sponsored by Northwestern University.

NCT01014754 is a clinical trial that has completed, run by Northwestern University. The registered enrollment target is 24 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01014754 has completed, sponsored by Northwestern University.

COMPLETED
Registry status
24 participants
Enrollment target

Study Summary

The primary objective of this study is to determine any causative or associated factors for the development of Nephrogenic Systemic Fibrosis (NSF), Nephrogenic Fibrosing Dermopathy (NFD), or related diagnosis. Our primary focus will be on the previous administration of gadolinium to these patients, but we will also look at other postulated causes and risk factors. The secondary objective of this study is to assess tissue gadolinium (Gd) levels in five groups of subjects: * Those affected by NSF. * Those with normal kidney function who have undergone a medical imaging procedure using Gd-based contrast agent (GBCA) in the 2 years prior to a skin biopsy. * Those with normal kidney function who have never been exposed to GBCA and have had a skin biopsy. * Those on dialysis or with eGFR ≤ 30 ml/min/1.73 m2 who have had a medical imaging procedure using GBCA in the 2 years prior to skin biopsy. * Those on dialysis or with eGFR ≤ 30 ml/min/1.73 m2 who have never been exposed to GBCA and have had skin biopsy. We hypothesize that there is a correlation between the administration of Gd-containing agents usually associated with MRI procedures and the development of NSF in those with renal failure and some other predisposing condition. We also hypothesize that tissue Gd levels in those with NSF will be higher than in those who have been exposed to GBCA but do not have NSF. Of the two groups without NSF but with exposure to GBCA, we hypothesize that those with kidney dysfunction will have higher tissue Gd levels than those with normal kidney function. We hypothesize that in the two groups of subjects without exposure to GBCA, there will be no detectable levels of Gd, regardless of kidney function status.

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2007-08
Est. Completion 2014-06
Northwestern University

1,209 total trials

What the finished NCT01014754 record still lists

NCT01014754 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 24 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01014754 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01014754 about?

NCT01014754 is a clinical study titled "Nephrogenic Systemic Fibrosis (NSF): Analysis of Tissue Gadolinium Levels". The primary objective of this study is to determine any causative or associated factors for the development of Nephrogenic Systemic Fibrosis (NSF), Nephrogenic Fibrosing Dermopathy (NFD), or related diagnosis. Our primary focus will be on the previous administration of gadolinium to these patients, ...

What is the current status of trial NCT01014754?

This trial is currently completed. The enrollment target is 24 participants. The study started on 2007-08. Estimated completion is 2014-06.

Who is sponsoring clinical trial NCT01014754?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01014754, the US trial registry maintained by the National Library of Medicine. NCT01014754 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.