Prospective Evaluation of the Incidence of NSF in Patients With Kidney Disease Undergoing MR

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Phase 4, open-label, two-year, prospective, multi-center, follow-up study conducted at up 15 sites in USA. Approximately 1,000 patients with moderate-to-severe CKD will be enrolled and followed for up to 24 months.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00811863

Nephrogenic Systemic Fibrosis Renal Insufficiency

WITHDRAWN

Evaluation of the Risk of NSF Following MultiHance Injection in Patients With Chronic Kidney Disease

NCT00600951

Renal Insufficiency

COMPLETED

An Open-Label, Long-term Study of GFB-887 in Patients With Glomerular Kidney Diseases

NCT04950114

Kidney Diseases Glomerulosclerosis Focal Segmental Nephrosis +4 more

TERMINATED PHASE2

Study on Efficacy and Safety of LNP023 in C3 Glomerulopathy Patients Transplanted and Not Transplanted

NCT03832114

Glomerulonephritis

COMPLETED PHASE2

CKDu Treated With Intra-arterial Infusion of Autologous SVF Cells

NCT05154591

Chronic Renal Failure of Unknown Cause

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Phase 4, open-label, two-year, prospective, multi-center, follow-up study will be conducted in up to 15 active sites in the United States. All patients will receive 1 dose of Ablavar as part of an MRI examination in their routine clinical management. Prior to undergoing an Ablavar MRI, patients will have a baseline serum creatinine test within 24 hours prior to Ablavar administration, will sign an Informed Consent (IC) form, will undergo a limited exam for skin abnormalities, and will undergo a brief medical history assessment on the day of and prior to Ablavar administration. A standardized NSF questionnaire will be administered to the patient at 48 (+ or -12) hours, 1 month (+ or - 1 week), 3 months (+ or - 2 weeks), 6 (+ or - 1) months, and 18 (+ or - 1) months post-dose. At 12 (+ or - 1) months, and at 24 (+ or - 1) months. Patients will return to the clinic for a limited examination for skin abnormalities and formal review of signs and symptoms suggestive of NSF.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nephrogenic Systemic Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ablavar

One dose of Ablavar will be administered for use during a contrast MRI examination

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Kidney Disease with GFR \< 60 mL/min./1.73 m\^2. Clinical Need to Receive an MRI with Contrast. Understand \& Sign Informed Consent.

Exclusion Criteria

History of known or suspected NSF. Has received any gadolinium based contrast agent within 12 months prior to enrollment.

Has a clinically significant skin disorder which may interfere with detection of cutaneous NSF manifestations.

Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives.

Is unable or unwilling to return for necessary office visits or follow up calls, and/or to be examined by a physician or undergo deep skin biopsy should the development of NSF be suspected.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No