Patients with moderate renal insufficiency (estimated eGFR > 30 and estimada 30 y <60 ml/min/1,73 m2). MedDRA version: 9.1 Level: LLT Classification code 10064499 Term: Nephrogenic fibrosing dermopathy
Conditions
Interventions
Trade Name: OMNISCAN 0,5 mmol/ml solución inyectable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GADODIAMIDA
CAS Number: 122795-43-1
Other descriptive name: GADODIAMIDE
Concentra
Sponsors
GE Healthcare Limited and its Affiliates
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) The subject is 18 years of age or older at time of study entry. (2) The subject is physically able and willing to comply with study procedures and a signed and dated informed consent is obtained. (3) The subject has been referred for a clinically indicated MRI examination with a gadolinium-based contrast agent (GBCA). (4) The subject has known or suspected chronic kidney disease with an eGFR >30 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (1) Patients with known or suspected NSF based on biopsy confirmation or the onset of signs and symptoms of NSF lasting at least 7 days as follows: (a) skin - swelling, hardening and tightening; reddened or darkened patches; burning or itching ; (b) eyes - yellow raised spots on whites of eyes; or (c) bones and muscle - stiffness in joints; difficulty in moving or straightening of arms, hands, legs or feet; bone pain especially in hips and ribs or muscle weakness. (2) Patients allergic to any GBCA. (3) Patients with chronic renal disease with a GFR <30 mL/min/1.73m2 as measured within 30 days prior to the planned index OMNISCAN administration. (4) Patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri-operative liver transplantation period. (5) Patients that were exposed to any GBCA within a period of 12 months prior the planned index administration of OMNISCAN.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To capture post-marketing safety information on patients with moderate renal insufficiency (eGFR >30 and <60 mL/min/1.73m2) undergoing routine contrast-enhanced MRI with OMNISCAN in order to assess the risk of developing nephrogenic systemic fibrosis (NSF).;Secondary Objective: Not applicable.;Primary end point(s): The primary endpoint will be the development of NSF, whether or not confirmed histologically. | — |
Countries
Spain
Outcome results
None listed