Evaluation of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Following OptiMARK Injection

NCT00811863 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2017-08-02

No results posted yet for this study

Summary

The objective of this study is to prospectively monitor the incidence of adverse drug reactions, specifically NSF during routine use of gadoversetamide in a large number of patients with moderate renal insufficiency (eGFR 30-59) and severe renal insufficiency or end-stage renal disease requiring dialysis (eGFR \<30).

Conditions

  • Nephrogenic Systemic Fibrosis
  • Renal Insufficiency

Sponsors & Collaborators

  • Guerbet

    lead INDUSTRY

Principal Investigators

  • Herbert R. Neuman, MD · Mallinckrodt

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2012-05-17
Completion
2012-05-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00811863 on ClinicalTrials.gov