Evaluation of the Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Without Exposure to Gadolinium Based Contrast Agents (GBCA)

A Prospective Study Evaluating the Incidence of Nephrogenic Systemic Fibrosis in Patients With Stages 4 to 5 Chronic Kidney Disease Without Exposure to Gadolinium Based Contrast Agents Within the Past 10 Years

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00773409

Enrollment

405

Registered

2008-10-16

Start date

2008-10-31

Completion date

2012-07-31

Last updated

2012-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Insufficiency

Brief summary

The objective of this long term study is to prospectively evaluate the incidence of NSF in patients with severe CKD or kidney failure including patients undergoing dialysis (stages 4 and 5 i.e., with an eGFR below 30)who have not had exposure to a GBCA within 10 years prior to enrollment.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Has CKD with an eGFR below 30 mL/min/1.73m2 and/or undergoing dialysis as calculated from a serum creatinine (SCr) value obtained from the local laboratory within 24 hours prior to signing the informed consent; * Provides written informed consent and is willing to comply with protocol requirements

Exclusion criteria

* Has received a GBCA within the past 10 years prior to inclusion in this study including the administration of a GBCA for something other than an MRI (e.g., CT or DSA); * Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives; * Has ever been suspected of, or diagnosed with, NSF; * Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy and laboratory/other diagnostic evaluations should development of NSF be suspected.

Design outcomes

Primary

Measure	Time frame
To estimate the incidence of NSF in patients that have not been exposed to GBCA within the last 10 years with severe CKD including those undergoing dialysis observed during the follow-up time period over the total number of eligible patients.	1,3,6,12,18,24 months

Countries

United States

Outcome results